BSA_April_2016

Inductively Coupled Plasma Mass Spectrometer
ICPMS-2030
Innovation - Industry's first method development and
diagnostic assistant functions
Accuracy - Newly developed collision cell achieves
high sensitivity with low interference
Economic - Proprietary technology realizes low running
costs, among the industry’s best

BioEdit
4 BioSpectrum | April - May 2016 | www.BioSpectrumAsia.com | An MM Activ Publication
I
ndia’s $20 billion pharma indus-
try has been shell-shocked by a
sudden government announce-
ment in mid-March 2016 ban-
ning the production and sale of 344
fixed dose combination (FDC) drug
production and sale.Analysts estimate
that these drugs, some of them very
popular brands of cough syrups, anti-
infectives, anti-cholesterol treatments,
account for at least 10% of the indus-
try’s revenue.
A High Court in the national capital Del-
hi has given a temporary relief to the
manufacturers,who are some of the leading
global pharma giants as well as domestic ge-
nerics drug makers,and is hearing the case on
priority.There has been some intense debate
within the health community in the past seven
years over these FDCs.There are more than
6,000 generic FDC products that have become
very popular with patients as well as doctors for
their usefulness and efficient treatment proto-
col.
The Indian government had appointed an ex-
pert committee, headed by a pharmacologist,
C K Kokate, to study the issue and its recom-
mendations were submitted in January 2015.
Subsequently, there was no public debate on
the expert committee report till the mid-March
2016 announcement on the ban of 344 FDCs.
Globally, FDCs are used widely and the US
regulator FDA has approved 131 FDC products
from 1990 to 2013.
The Active Pharmaceutical Ingredients (APIs)
that go into making of FDCs are individu-
ally approved by regulators around the world.
Regulators also provide guidelines on FDC
formulations.In an exhaustive study on FDCs
done by two Turkish pharmacologists,Timucin
Ugurluand Tugce Ozaydin, at the Marmona
University, the researchers found not adverse
side effects reported by most of the FDC drugs
prescribed widely in the world.
In fact, they highlighted the beneficial effect
of a combination of Amlodipine and Valsar-
tan in lowering blood pressure in patients sig-
nificantly compared to their individual use.
The researchers noted that FDCs are highly
successful in treatments related to cardiovas-
cular diseases, infectious diseases, diabetes,
psychiatric disorders and respiratory illnesses.
The only drawback is that it is not very easy to
pinpoint quickly which of the APIs contribute
to side-effects, if any reported by patients.
Metformin is one of the most popular drug in
treating diabetes.Inrecent years, metformin
has been combined with different dosages of a
new class of drugs called gliptins and the com-
binations have beenfound to be highly effective
in diabetes management. There are many more
such examples of combination drugs that are
highly effective.
While hearing the case, a judge in the Delhi
court asked a pertinent question to the govern-
ment’s lawyer. When the drug regulator has
approved these drugs, APIs and their combina-
tions after rigorous scrutiny, how can another
expert find fault with these? And how long can
the regulatory approval process go on with-
out any certainty?The government lawyer just
spouted the excuse of ‘public interest’ for the
ban on these drugs.The decision of this court
will holdsignificance not just for the pharma
industry in India but around the world in the
near future.It could be trendsetter for this sec-
tor in many ways.
Meanwhile, the industry and regulators have
to share more data on the rationale for use of
FDCs and put things in perspective on this con-
tentious issue. BS
Narayanan Suresh
Group Editor
narayanan.suresh@mmactiv.in
B an on Fixed Dose Combination (FDC)
drugs hits India pharma

BioMail
An MM Activ Publication | www.BioSpectrumAsia.com | April - May 2016 | BioSpectrum 5
Excellent read
The entire segment called ‘A decade of growth‘ was an
excellent read. It revived the entire decade of the bio-
tech industry. Refreshing the stories that was burning
issues and major happening in the industry, it’s good to
know that the biotech sector has evolved substantially
in the past 10 years.
James,Korea
Wonderful wearables
This is with reference to the story on wearables in the
last issue of the magazine. Wearables are increasingly
becoming an important tool to monitor health. How-
ever, I believe better policies and a strong regulatory
framework,will go a long way in exploiting this new tech-
nology in a healthy way.
Julie Tan, Malaysia
Excellent flashback!
I have been an avid reader of BioSpectrum for the past
many years and have been reading the yearly round-
ups. This is the first time I have read the flashback for
the entire decade! Kudos to BioSpectrum for coming
up with interesting and informative articles every month.
Zack Mathison, Taiwan
Big data for healthcare
Big data has immense potential
for healthcare sector, but un-
fortunately the sector has been
slow in exploiting the usage of
big data. Though the traction has
increased in the past few years
but not too much. Other sectors
are already benefitting from big
data, hopefully healthcare will
also join the bandwagon soon.
Carl Benedict, Singapore
Congratulations to BioSpectrum
My heartiest congratulations to BioSpectrum Asia and
its team as the publication turned 10 in March, celebrat-
ing a decade of relentless existence. I’m very impressed
by your quality editorial content which is a perfect bal-
ance between Science & Technology and Business. The
story ‘A Decade of Growth’ in your 10thanniversary edi-
tion took me through 10 mind-blowing developments in
the bioscience industry. On similar lines, I’m wondering
if you could highlight at least one big breakthrough in
bioscience in each edition. Overall, job well done!
Shalmalee Vaidya, Singapore
1www.biospectrumAsia.com | March 2016 | BioSpectrum
CoverStory
BioSpectrum is an publication; MCI (P) 115/10/2014
A DECADE OF
GROWTH
| ł Ð é Ý Ë ‰ ł ú Ž
1
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Executive Editor: Srinivas Rasoor
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Vol 11; Issue 4; April - May 2016
Vol 11; Issue 3;
March 2016

Latest
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Technologies
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COVERSTORY16
Siemens Healthcare, India17
ARE YOU READY FOR
LABORATORY TRANSFORMATION?
Thermo Fisher Scientific20
CRISPR-CAS9 GENOME EDITING –
SIMPLE GENOME EDITING
STARTS HERE
Horizon Discovery23
CRISPR–CAS9: A NEW HOPE
FOR DRUG DISCOVERY
Eppendorf India26
TRIUMPH OF HIGH PRECISION
PARALLEL BIOREACTORS OVER
CONVENTIONAL SYSTEMS
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SINGLE USE MICRO SCALE
BIOREACTOR ENABLES HIGHER
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EXPLORING NEW FRONTIERS IN
BIOLOGICAL SCIENCE USING
MASS SPECTROMETRY
In the ensuing pages, BioSpectrum is publishing a selection of open invitation
articles by the industry captains, highlighting the latest BioSupplier technologies/
products that are enabling the biosciences industry on the course of drug discovery.

REGULARS
BioEdit��04
BioMail��05
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10 India’s trillion-dollar opportunities in ICT, IoT
BIOIT
QE Prize winner
Dr Langer shares his
success
Dr Robert Langer
Winner of Queen Elizabeth Prize of Engineering 2015, David H Koch
Institute Professor, Massachusetts Institute of Technology (MIT), USA
08
36 Biosimilars are opening
up new opportunities
Mr Christiaan Engstrom
President, Cell Culture Company
BIOTALK
47
BIOCOLUMNS
Driving public health impact with vaccines
The past, present and way forward
Dr Joselito Sta Ana
Senior Director, Regional Head Dengue, Sanofi Pasteur Asia Pacific
BIOANALYSIS
49
Lung cancer burden
of Asia

BioTalk
QE Prize
winner
Dr Langer
shares his
success
Dr Robert Langer
Winner of Queen Elizabeth Prize of Engineering
2015, David H Koch Institute Professor, Massa-
chusetts Institute of Technology (MIT), USA
T
he Queen Elizabeth Prize for Engineering is con-
sidered as the highest international accolade for
engineering, and recognizes ground-breaking
global innovation to inspire next-gen engineers.
The award is a global £1 million prize celebrating pio-
neering innovations that has had a profound benefit to
humanity globally.
Dr Langer lab’s work is at the interface of biotechnology
and material science. His lab’s major focus is in studying
and development of polymers to deliver drugs, particu-
larly genetically-engineered proteins, DNA and RNAi,
continuously at controlled rates for prolonged periods of
time.
Dr Langer exclusively spoke to BioSpectrum, where he
shared his passion, origins, memories of his childhood
laboratory, entrepreneurial tips and his award-winning
work on controlled-release drug systems. Excerpts:
Dr Robert Samuel Langer was awarded the 2015 Queen Elizabeth Prize
(QEPrize) for Engineering in February 2015 at the Royal Academy of Engineering,
London, UK. He is a world-renowned American scientist, engineer, inventor and
entrepreneur, and David H Koch Institute Professor at the Massachusetts
Institute of Technology (MIT), USA.

BioTalk
Firstly, a hearty congratulations Dr Langer.
Tell us about your award-winning work to
our Indian readers, and the impact of your
controlled-release drug systems.
A Thank you. I think engineering is such a wonderful
way to contribute to society. The two things that
give me the greatest satisfaction are discovering princi-
ples or making inventions that enable people to have hap-
pier and healthier lives, and seeing the people who train
in our lab succeed to become future leaders in engineer-
ing themselves.
There are times when drugs administered to patients
could react after being in the system for more than the
required period of time or they might be ineffective by
disappearing quickly. To tackle this, controlled drug re-
lease helps maintain and sustain the drug release at an
effective level for the suitable period of time. The polymer
which was invented through my study helps in controlled
dissemination of the drug molecules. My work which won
the QEPrize is on engineered polymers which control the
delivery of large molecular weight drugs for the treatment
of diseases such as cancer and mental illness. It is already
being used in various countries, including India.
I am thrilled to be the recipient of the Queen Elizabeth
Prize 2015. The prize celebrates ground-breaking innova-
tions in engineering and in addition strives to celebrate
stories of engineering successes, raising the international
public profile of engineering and inspiring new genera-
tions of engineers to take up the challenges of the future.
What sparked you to become a scientist?
A Some of it started as a child having chemistry, mi-
croscope and erector sets. My dad also played a lot
of math games with me. All this contributed to my liking
science and math.
Shed some light about the lab in your home’s
basement in Albany.
A It was a small basement and I had a Gilbert chem-
istry set. I put all the chemicals down there and I
loved doing experiments where I would make things like
rubber and make solutions change colors via chemical re-
actions.
You have a background in Chemical
Engineering. What made you to shift towards
Biomedical Engineering?
A I always wanted to learn biology. My PhD thesis
was on the enzymatic regeneration of ATP. I did my
postdoc in a surgery lab at Boston’s children’s hospital. I
was the only engineer in the hospital. It really gave me all
For young people, I’d say
dream big dreams, dreams
that can change the world
and make it a better place
kinds of ideas as to how chemical engineering could be
applied to medicine.
You have been researching since the 70s. How
difficult or hard has it been for you to achieve
what you have achieved today?
A Very difficult. My first nine research grants were
turned down largely because my research went
against conventional wisdom. No chemical engineering
department would hire me as a professor. And I ended up
joining a nutrition department. The year after I joined,
the department head who hired me left. So the associate
department heads decided to give me advice. They told
me to start looking for another job. Time helped me over-
come some of these issues as we proved that conventional
wisdom was incorrect. And I just never gave up.
You have over 1,000 patents to your credit.
How will you define innovation?
A A new idea or invention, and its implementation
into real life
You are also an entrepreneur too. What do you
have to say to all the scientists who want to be
an entrepreneur?
A: I think it’s an attractive career path but not the only
career path. Personally I love it because it enables myself
and my students to take our ideas into the real world and
help people. But science leads to many good career paths.
What are the common mistakes committed
by scientists while they pursue their
entrepreneurial dreams?
A Starting a company too early. Not having good in-
tellectual property (IPs).
What do you advice students who hesitate
to become a scientist or pursue a research-
oriented career?
A I think that’s okay. Everyone should get lots of ad-
vice. But they should follow their passion. I think
people should do things that make them happy. And they
shouldn’t do things just to make money. BS
Raj Gunashekar

BioIT
In recent years, Internet of Things (IoT) has emerged
as a buzzword, with both service providers and
businesses, exploring possibilities connected devices
can bring to the services they render and the way
they conduct their businesses. IoT solutions are
impacting the healthcare in a significant manner.
Today, enterprises are realizing that the adoption of
IoT in their operations will not only lead to increased
productivity and process efficiencies, but also a
reduction of costs.
While IoT is still at its nascent stages in India, the
potential is tremendous.
India’s trillion-dollar
opportunities in ICT, IoT
A
s a society, we are
becoming more
connected and the
pace at which new
technology is im-
pacting our every-
day lives is increasing at lightning
speeds.
Over the next decade, the IoT and
M2M (machine-to-machine) are ex-
pected to bring billions of data-gen-
erating devices online, and connect
a vast stream of data with people,
processes and other devices. There
are some niche applications such as
sensors record, ambulatory medi-
cal record (AMR) modem, and asset
tracking.
“In the pharma and healthcare in-
dustries,” says Mr Sai Pratyush, Ad-
ditional VP, Managed Services, Tata
Teleservices, “we see the increasing
use of IoT in the form of people con-

BioIT
necting to various healthcare devices.
Also the use of wireless technology
will allow healthcare workers and pa-
tients to rapidly access information.
M2M communication connected
wirelessly via sensors that transfer
data automatically will improve ef-
ficiencies.”
The healthcare industry has long
been overburdened by slow moving
innovation due to the complexity of
the medical ecosystem that’s chang-
ing aggressively, and IoT and M2M
solutions are playing a catalyst role
in this change and revolutionizing
the pharma sector.
“It will also be helpful in providing
better medication-management and
will be the fastest growing segment
in the whole IoT market,” predicts
Mr Pratyush.
Technology is playing a significant
role in improving the quality of
healthcare, cost efficiency, precision
performance, proactive and on-time
care, real-time communication and
most importantly, saving lives.
Tata Teleservices is working with
partners to develop scalable ICT (In-
formation and Communication Tech-
nologies) and IoT solutions across
the healthcare value chain which in-
cludes hospitals, vendor ecosystem,
doctors and individuals.
The following are few areas which
will see innovation, and will benefit
Technology
is playing a
significant role
in improving
the quality of
healthcare.
Mr Sai Pratyush
Additional VP, Managed Services,
Tata Teleservices
facebook.com/BioSpectrumMagazine bit.ly/BS-LinkedInhttps://twitter.com/BioSpectrumMag

BioIT
both the industry as well as patients:
 Outpatient monitoring
 Wearables
 Remote monitoring or rural
healthcare
 mHealth
 Location based services
ICT Trends In Indian
Healthcare
ICT and IoT solutions are impacting
the healthcare in a significant man-
ner.
There is the wearables space which is
enabling and pushing ordinary peo-
ple to maintain a healthy lifestyle,
and then, there are those simple in-
novations which are enabling the
healthcare industry to provide better
quality of care to its patients.
Outpatient monitoring and telemedi-
cine applications are introducing the
healthcare industry to newer ways
of interaction with patients and en-
abling them to not only monitor pa-
tients on a continuous basis but also
respond more quickly to situations
that need their attention.
“As an example, a monitoring device
is given to the patient at the time of
discharge for a limited timeframe,
which helps the doctor to continue to
monitor the patient and suggest cor-
rective actions during the patient’s
recovery,” states Mr Pratyush.
As per a Deloitte Report, telemedi-
cine is witnessing fast adoption in In-
dia. In 2012, the telemedicine market
in India was worth $7.5 million, and
it is expected to rise 20% annually to
$18.7 million by 2017.
Telemedicine can provide low-cost
consultation and diagnostic facilities
to the remotest areas via high-speed
internet and telecommunications,
The major users of ICT include big
pharmaceutical companies, cor-
porate hospitals and other private
health sector institutions, while the
public healthcare sector is lagging
way behind in IT utilization. But the
good news is that the situation is
changing.
Mr Pratyush mentions, “Though ICT
solutions have had a positive im-
pact on the healthcare sector, there
are some challenges that need to be
overcome in order to provide afford-
able, high quality healthcare solu-
tions, and innovations to hospitals
and their vendor ecosystem, doctors,
and eventually the citizens of this
country.”
The government is now cognizant
that technology can help overcome
challenges arising due to geographi-
cal size, high-population density,
lack of healthcare infrastructure, in-
accessibility in rural India, poor nu-
tritional conditions, and low literacy,
among others.
Furthermore, the National Health
Policy endorsed by the Parliament of
India encourages the introduction of
electronic communication media in
health sector.
The Government of India also
brought in the National Rural Health
Mission for delivering the best-in-
class healthcare facilities to the rural
population.
The Ministry of Health and Family
Welfare and the Ministry of Com-
munication and Information Tech-
nology are jointly creating a national
health information infrastructure for
easy capture and dissemination of
health information.
Like all new disruptive technolo-
gies, IoT deployments face numerous
challenges.
thus, bridging the rural-urban divide.
In addition, India’s extensive mobile
technology infrastructure and better
connectivity infrastructure is expect-
ed to drive mobile health (mHealth)
adoption further.
He points, “Several people in our
country do not have ready access to
decent healthcare. There are many
challenges to set up a full-fledged
hospital at remote and rural loca-
tions.
However, IoT-based wireless solu-
tions are now making it possible for
doctors based in cities to monitor
patients located in remote villages.
Now, villagers need not travel long
distances to get a simple diagnosis
done.”
Mr Pratyush feels that solutions need
not involve complex ICT infrastruc-
ture.
“SMS-based solutions are enabling
doctors and hospitals to send re-
minders and alerts to their patients
on medication or health checkups.
“This management of medication
through SMS platform ensures doc-
tors and hospitals provide best pos-
sible care to their patients,” he adds.
Challenges to disruption
Despite being an IT-enabled servic-
es behemoth, the use of ICT in the
healthcare sector is limited in India.
The government is
now cognizant that
technology can help
overcome challenges
arising due to
geographical size, high
population density

BioIT
THE CLOUD ADOPTION
Though cloud computing is still a concept that exists only in theory for
the Indian healthcare industry, the healthcare vertical has made it to
the potential list of every cloud vendor and service provider.
Mr Pratyush says, “It is not surprising, given the general opinion that
healthcare industry is rapidly automating itself, and soon enough, will
be leapfrogging towards the cloud.”
Research agencies like Zinnov have derived that the healthcare industry
currently spends only about 2% of their total budgets on IT. This figure
is set to grow to 15 to 20% in 2015, and up to 40% in 2020, purely to-
wards adoption of cloud services.
This will mean that the cloud opportunity within the healthcare seg-
ment could touch $600 million in 2020. At a CAGR growth rate pegged
at 25%, healthcare is definitely one of the most promising segments as
far as cloud adoption is concerned.
“With connected IoT devices, reliable
bidirectional signaling is essential for
collecting and routing data between
devices. You need to be 100% sure
that that stream of data is going to
arrive at its destination every time,”
emphasizes Mr Pratyush.
Security is another important factor
in IoT connectivity.
“What good is a smart home if any-
one can unlock your doors, or for
that matter anyone can access your
health records?” asks Mr Pratyush.
“Solutions need to ensure that when
sending or receiving a stream of data,
the IoT device or server has proper
authorization to send or receive that
stream of data, and most important-
ly, you need end-to-end encryption
between devices and servers.”
Huge and uninterrupted power
consumption is also seen to pose
challenges. “Billions of IoT devices
which are required to transmit data
between one another will require un-
interrupted power either through the
grid or battery bank,” he stresses.
Currently most solutions deployed in
the country are based on proprietary
technologies which make it difficult
for customers to scale or opt out in
case the solutions are not working for
them.
Tata Teleservices is working with
partners to create innovative ICT so-
lutions for the healthcare industry.
These solutions address the basic
needs of providing telecom infra-
structure as well as more complex
IoT solutions such as LBS (Location-
based services) or healthcare-related
applications.
Trillion dollar opportunity
As far as the IoT market opportunity
is concerned, while findings of market
research companies may vary, they
are unanimous in their conclusion
that this is a trillion dollar opportu-
nity in terms of revenue potential.
A recent study by a global network-
ing major predicted that there will
be 25 billion devices connected to
the internet by 2015, and 50 billion
by 2020, thus highlighting its promi-
nence in the coming decade.
Mr Pratyush explains, “We have seen
IoT and M2M deployments primar-
ily in the utilities and transportation
space, but that is changing slowly.
As the devices, sensors and applica-
tion ecosystems grow, we are seeing
investments being made across BFSI
(Banking, Financial Services and In-
surance), retail, healthcare and even
the home and building management
space. The Government of India
is also playing a significant role in
adopting ‘smart IoT technologies’.
The ‘Smart Cities’ program as well
as ‘Digital India’ is leading entre-
preneurs to make substantial invest-
ments in this space.”
Globally, IoT has seen deployment
across transport, utilities, retail, logis-
tics, home automation and security.
“The West is definitely a few steps
ahead in terms of use cases and scale
of deployments, but it would be in-
correct to say that we are ‘very’ far be-
hind,” he opines. “The next few years
will be critical for India, and I believe
we have a good opportunity to bridge
the gap. The Government’s ‘Digital
India’ program and ‘Smart Cities’ ini-
tiatives will further the cause of IoT
substantially.”
Tata Teleservices has been develop-
ing IoT solutions for its customers
across a host of use cases and indus-
tries which includes the healthcare
industry.
“Our solutions encompass not only
the telecom infrastructure but the de-
vices and application as well in select
verticals. Healthcare is a key vertical,
and we are working with partners to
create solutions which will be benefi-
cial for our customers,” concludes Mr
Pratyush. BS
Raj Gunashekar

Latest
BioSupplier
Technologies
The invention of the microscope is one of the most
important scientific development. Since then the
development in the laboratory instruments and
technologies have grown by leaps and bounds.
The Human Genome Project to sequence the
human took 13 long years. Today, it is possible to
sequence DNA in a couple of hours.
As research and development in the biosciences
grows, so is the demand for more sophisticated
technologies, instruments that are affordable,
precise and timely.
In the ensuing pages, BioSpectrum is publishing
a selection of open invitation articles by the
industry captains, highlighting the latest BioSupplier
technologies/products that are enabling the
biosciences industry on the course of drug discovery.
CoverStory

CoverStory
Are you ready
for laboratory
transformation?
Mr Amit Manjure
Head-Clinical Marketing, Laboratory Diagnostics,
Siemens Healthcare, India
The influence
of diagnostic
tests on
clinical decisions
is very high.
The global in
vitro diagnostics
market is
estimated to
reach $75.1
billion by 2020
R
ising populations
in emerging econ-
omies will lead to
increased demand
for medical de-
vices, diagnostic
equipment and pharmaceuticals in
the near future. At the same time,
this demand will leverage tech-
nological advances. In vitro diag-
nostics (IVD) is one such industry
that is witnessing proliferation of
technology in terms of new assays,
workflow excellence, turnaround
time, etc.
IVD plays an integral role in health-
care and disease management.
The influence of diagnostic tests
on clinical decisions is very high
– almost 75% of clinical decisions
are based on a diagnostic test. The
global in vitro diagnostics market is
estimated to reach $75.1 billion by
2020, growing at a CAGR of 5.8%.
The Indian IVD industry, still in the
inception stage is valued at more
than $500 million and is expected
to surpass $1.5 billion by 2018.
Growth Drivers for IVD
With a population of more than 1
billion, India is world’s second larg-
est country and therefore a signifi-
cant market to the healthcare pro-
viders. The demographic change
has led to growth in tier 2 and tier
3 cities creating disposable income
ultimately leading to a change in
lifestyle patterns and an increase in
the lifestyle diseases like cardiovas-
cular diseases, lung disease, cancer,
obesity, diabetes, etc. One in four
Indians is at a risk of non-commu-
nicable lifestyle disease.
Accurate and quick diagnosis of
diseases has thus become a crucial
factor in providing quality patient
care.
Turn-around time (TAT)
The diagnostics labs operate in a
dynamic environment. In addition
to the accurate diagnosis, reduced
turnaround time (TAT), consistent
delivery and affordability have be-
come the need of the hour. Turn-

CoverStory
around time is the most noteworthy
manifestation of laboratory service
and a crucial barometer of laboratory
performance. As a result, laborato-
ries of all sizes are adapting total au-
tomation across pre-analytical, ana-
lytical and post-analytical processes
integrated with information technol-
ogy (IT) since information systems
are a key differentiator among major
healthcare providers.
The innovations and discoveries in
the IVD market are transforming the
healthcare arena. The IVD market in-
cludes a variety of advanced and cut-
ting edge technologies to project the
disease state, choose the right treat-
ment and monitor thepatientsresponse
to the treatment. An array of assay ca-
ters to wide spectrum of diseases.
Automation, a unified solution de-
veloped expressly for the changing
workload and expanding needs of to-
day’s clinical laboratory, is playing a
key role in the entire diagnostics set
up. It provides unlimited potential
for lab optimization by combining
peak performance, adaptability, and
intelligent technology. However, the
challenges of implementing lab au-
tomation can be formidable. It is a
complex undertaking to meet busi-
ness objectives and clinical require-
ments while managing logistics,
timelines, people and technology to
achieve workflow excellence. And the
operations must continue uninter-
rupted during this transition!
The work in any laboratory is typi-
cally broken in three phases.
1. The pre-analyticalphase: this
comprises of patient sample iden-
tification, test request registration
and billing, sample collection,
labeling by barcode, separation
followed by transport and sample
processing.
2. The analytical phase: this com-
prises of properly calibrating the
instruments, the quality control
process and analysis of samples.
3. The post-analytical phase: This
includes all the processes that
follow the testing of the samples.
Namely, the validation of test re-
sults, transcription of results into
the records, printing and dispatch
of the results. Also, the data so
generated needs to be stored. The
samples also need to be stored
for specified period of time for
repeats or add-ons.
With this background, it is critical for
laboratories to optimize the follow-
ing flow across these three phases.
 The sample flow has to do with
the collection of the samples, to
sorting, transportation until their
disposal and/or they are sent out.
 The data (information) flow goes
from order entry to receiving or
accessing, quality control, etc. all
the way to validation, reporting
and billing.
 The material flowincludes inven-
tory tracking; invoicing and pay-
ment etc.
Removal of non value-added steps
such as reducing sample touch
points, manual bench sorting ali-
quoting transportation, sample re-
run, results review is a key to achiev-
ing workflow excellence.
Automation – the way
ahead!
Statistics indicate that there has been
an approximately 25 percent increase
APTIO AUTOMATION INTELLIGENT, TEST-DRIVEN,
TUBE ROUTING ON APTIO PLATFORM

CoverStory
in laboratory tests due to screening
and follow up for lipid profile, blood
glucose levels, glycosylated haemo-
globin, speciality tests for thyroid hor-
mone levels, vitamin levels, infectious
serology and basic cancer markers.
The diagnostics and pathological lab
test market has the potential to grow
at a CAGR of 18.9 percent.
With automation, labs of all sizes can
transform their operations to harness
change and drive maximum perfor-
mance and efficiency. Laboratories
can also customize their automation
solutions by identifying the sustain-
able workflows. Labs can consolidate
multi discipline testing into a single,
fully automated solution or improve
spatial efficiency, tube utilization,
or resource allocation. Siemens has
helped diagnostic laboratories lever-
age the benefits of automation and
information technology since 1998—
making workflow more efficient and
flexible while improving turnaround
times, reducing errors, and cutting
costs.
Laboratory automation allows for
a broader diagnostic scope and in-
creased accuracy. Ultimately, labo-
ratories will be able to perform more
tests in-house and reduce their de-
pendency on outsourcing services in
addition to the decrease in number
of duplicative laboratory process and
increase in throughput.
This will also allow staff to be better
utilized beyond bench testing and
routine operation including but not
limited to patient interaction,finance,
marketing services and strategic
planning. BS
Statistics indicate
that there has been
an approximately 25
percent increase in
laboratory tests due to
screening and follow
up

CoverStory
CRISPR-Cas9
genome editing
– simple genome
editing starts here
Namritha Ravinder
Senior RD Manager, Synthetic biology, Thermo Fisher Scientific
The new
GeneArt
CRISPR
Search
Design tool
allows scientists
to search a
database of
600,000
pre-designed
CRISPR gRNAs
in human and
mouse genes
I
ntroducing the only com-
plete genome editing solu-
tion designed to expedite
your research. Our easy-
to-use, optimized and val-
idated solutions span the
entire cell engineering workflow,
making genome editing accessible
to anyone at any level. We are con-
tinuing to expand our suite of ge-
nome editing products to span the
entire cell engineering workflow,
from cell culture reagents, delivery
reagents and sample preparation
to genome modification, detection
and analysis of known genetic vari-
ants. We offer our state-of-the-art
online CRISPR search and design
tool along with CRISPR-Cas9 in
four formats: an all-in-one expres-
sion vector, Cas9 mRNA, Cas9 pro-
tein, and CRISPR libraries services
paired with the optimal cell culture
reagents, delivery method, and
analysis tools based on required
application and cell type (Figure 1).
Optimal CRISPR design
at the touch of afinger
The new GeneArt CRISPR Search
Design tool allows scientists to
search a database of 600,000 pre-
designed CRISPR gRNAs in human
and mouse genes or analyze their
sequence of interest for de novo
gRNA designs using Thermo Fish-
er’s proprietary algorithms. The
tool is designed to analyze genes of
interest, identify gRNA sequences
adjacent to protospacer adjacent
motif (PAM) sites, and rank order
resulting gRNAs based on potential
off-target effects. Up to 25 gRNA
sequences per gene are provided
with recommendations based on
potential off-target effects for each
CRISPR sequence.
Invitrogen GeneArt Platinum Cas9
Nuclease is wild type Cas9 in pro-
tein form for genome editing with
CRISPR-Cas9 technology. Cas9
protein and guide RNA (gRNA)
form a very stable ribonucleo pro-

CoverStory
NamrithaRavinderisaseniorRDmanageratThermoFisherScientificinCarlsbad,California.Sheleads
productdevelopmentactivitieswithintheSyntheticBiologyandSamplePrepteam,withprimaryfocus
onbuildingproducts,screeningtoolsandworkflowsforgenomeeditingandcellengineeringapplications.
Priortohercurrentrole, she was a technical lead for a wide variety of synthetic biology custom
service offerings including cDNA library generation; high-throughput gene expression and miRNA
profiling for biomarker discovery; lentivirus production; and next-generation sequencing libraries.
She did her postdoctoral research at Children’s hospital in Los Angeles in HIV virology and doctoral
research in plant molecular biology and biotechnology at University of Alabama inHuntsville.
BRIEF PROFILENAMRITHA RAVINDER
tein (RNP) complex that provides
the next level of cleavage efficien-
cy over CRISPR-Cas9 vector and
mRNA-based systems when paired
with Invitrogen Lipofectamine CRIS-
PRMAX Cas9 Transfection Reagent.
The Cas9 RNP complex can act im-
mediately after it enters the cell,
since transcription and translation
are not required (Figure 2). More-
over, the complex is rapidly cleared
from the cell, minimizing the chance
for off-target cleavage events when
compared to vector-based systems.
GeneArt Platinum Cas9 Nuclease
is the recombinant Streptococcus
pyogenes Cas9 (wt) protein purified
from E.coli that can be used for ge-
nome editing with CRISPR technol-
ogy. Features and benefits include:
 Two available concentrations
 1µg/µL(B25640) for use instan-
dardediting scenarios, including
cell lines such as HEK293 or
HCT116
 3 µg/µL (B25641) for optimiza-
tion of editing conditions in more
difficult scenarios such as in
primary or embryonic cell lines,
or when screening multiple gRNA
sequences at a time
 Streamlined cell engineering by
eliminating transcription and
translation in the cell
 Elimination of time-consuming
cloning steps
 Minimization off-target cleavage
due to rapid clearance of the pro-
tein complex from the cell
The GeneArt Precision gRNA Synthe-
sis Kit is a complete system for rapid
synthesis of guide RNA (gRNA),
ready to complex with GeneArt Plati-
num Cas9 Nuclease for transfection-
ready Cas9 protein/gRNA ribonu-
cleoprotein (Cas9 RNP). Features
and benefits include:
 Fast assembly and synthesis of
any gRNA target in as little as
four hours, including template
assembly
 High yield (10 µg) and concen-
tration ( 200 ng/µL) of gRNA
The Lipofectamine CRISPRMAX
Cas9 Transfection Reagent is the first
optimized lipid nanoparticle trans-
fection reagent for CRISPR-Cas9
protein delivery, providing the cleav-
age efficiency of electroporation with
the simplicity and scalability of a re-
agent. Lipofectamine CRISPRMAX
transfection reagent is an ideal al-
THE PERFECTPAIRING
We have paired the CRISPR-Cas9 format and delivery method for scientists to ensure the
highestefficiencies.

CoverStory
ternative to electroporation as it is
gentleron cells and more cost effec-
tive overall (Figure 3). Features and
benefits include:
 Demonstrated cleavage efficiency
tested in more than 20 cell types
including iPSC, mESC, N2A,
CHO, A549, HCT116, HeLa,
HEK293, and several others
 Low cell toxicity—fewer cells
needed to initiate your experi-
ment
 Cost savings—including both cost-
per-reaction and initial invest-
ment
 Easy scalability—an ideal deliv-
ery solution for high-throughput
experiments
Advances in genome modulation and
editing have the potential to change
the way we create energy, produce
food, optimize industrial processing,
and detect, prevent, and cure diseas-
es — improving the human condition
and the world around us. Thermo
Fisher’s trusted products harness the
power of science to transform lives.
Its instruments, routine tools, and
services offer high-quality, innova-
tive life science solutions for every-
lab. BS
WORKFLOW
Advances in genome
moudulation and
editing have the
potential to change
the way we create
energy, produce food,
oprtimize industrial
processing, and cure
diseases

CoverStory
CRISPR–Cas9:
a new hope for drug discovery
Dr Ceri Wiggins
Team Leader, Horizon Discovery
Thought to
be devoid of
the caveats
associated
with siRNA and
shRNA reagents
the hope is
that novel
targets can be
uncovered
T
he repurposing of
a primitive adap-
tive immune re-
sponse in bacteria,
known as CRISPR
(clustered regularly
interspaced short palindromic re-
peat), has revolutionized gene edit-
ing and provides a new and power-
ful tool to interrogate gene function
on a genome-wide level. Indeed,
the contribution of this technology
to drug discovery looks, from our
current vantage point, to be sub-
stantial. The application CRISPR–
Cas9 technology to whole genome
screening is transforming our abil-
ity to perform target identification
experiments and to understand
complex biological processes, such
as drug resistance. Thought to be
devoid of the caveats associated
with siRNA and shRNA reagents,
the hope is that novel targets can be
uncovered and rigorously validated
using CRISPR–Cas9, and that a
pipeline of innovative and validat-
ed targets will enter drug discovery
programs.
Indels are crucial: CRIS-
PR–Cas9 screens make use ofshort
guide RNAs (sgRNAs) and Cas9
nuclease, two components of the
CRISPR machinery in bacteria. The
sgRNA, which Cas9 binds to, con-
tains a protospacer adjacent motif
(PAM) site and this enables the tar-
geting of Cas9 to the RNA:DNA hy-
brid. Once bound, the Cas9 nucle-
ase generates DNA double strand
breaks precisely 3 base pairs away
from the PAM site. These double
strand breaks are repaired by non-
Dr Steffen Lawo
Senior Scientist, Horizon Discovery
Narinder Singh
commercial contact, Country
Head-India-Horizon Discovery.

CoverStory
Ceri Wiggins is a Team
Leader at Horizon Discovery,
currently responsible for
the internal synthetic lethal
CRISPR screening and target
identification/validation team.
Steffen Lawo joined Horizon
Discovery GroupasSenior
Scientist in 2013.
As Country Head at Horizon
Discovery, Narinder is responsible
for business development of
Horizon’s product and service
portfolioacross India and Middle
East.
BRIEF PROFILE BRIEF PROFILE BRIEF PROFILE
DR CERI WIGGINS DR STEFFEN LAWO NARINDER SINGH
homologous end joining (NHEJ),
which frequently results in small nu-
cleotide insertions and or deletions
(indels) that can lead to the inter-
ruption of the normal reading frame,
thereby disrupting gene function.
Pooling resources: Using
lentiviral transduction to deliver both
the Cas9 nuclease and sgRNAs into
cells, Horizon Discovery has adapted
a pool-based screening protocol to
examine the effect on cell survival of
knocking out thousands of individual
genes. The sgRNAs are designed to
direct Cas9 to exons at the start of
the open reading frame, such that
any out-of-frame indels will result in
gene disruption. The screen analysis
is based on data from cells collected
at the start of the screen (3–5 days
after transduction) compared with
cells collected at the end of a screen
that have been exposed to a drug of
interest, for example. The next gen-
eration sequencing (NGS) data from
the initial time point acts as a com-
parator for the NGS data collected
at the end of the screen, such that
sgRNA loss and gain over the time of
the screen can be established. We use
a dedicated CRISPR–Cas9 screening
analysis platform, adapted from the
MAGeCK workflow (Li et al., 2014),
which enables individual sgRNAs
and gene hits to be ranked.
Resistance discovery
ahead of the clinic
Many of the initial screens that Ho-
rizon Discovery has undertaken for
a number of clients from the phar-
maceutical industry have examined
mechanisms of drug sensitivity and
resistance. Indeed, for our initial
proof of concept studies we, like oth-
ers, examined mechanisms of resis-
tance to vemurafenib, a drug that
targets the BRAFV600E activating
mutation. The GeCKOv2 genome
wide library, which contains 6 guide
RNAs against 19,050 genes (San-
janaet al., 2014), was transduced into
BRAFV600EmutantA375melanoma
cells and the cells were treated with
vemurafenib. A comparison of the
abundance of each guide RNA at the
start and end of the screen was used
to assess whether drop out or enrich-
ment of guide RNAs had occurred
over the course of the screen. Over
228 guides were shown to be 100-
fold enriched, with several sgRNAs
targeting the same genes. Using our
analysis platform, the highest rank-
ing targeted genes (MED12, NF1,
CUL3, NF2, TADA2B and TADA1)
were those whose loss is known to
confer resistance. These findings
repeated previously published data
(Shalemet al., 2013, Huang et al.,
2012, Whittaker et al., 2013).
Interestingly, when the sgRNAs for
each of these hits were evaluated
individually, it was clear that not all
guides performed equally well in the
screen. This emphasises that for suc-
cessful screening, the library compo-
sition and complexity are key consid-
erations.
Increasing the odds with
a haploid approach
Engineered from KBM7 fibroblasts,
eHAP cells are a fully haploid cell
line and are particularly suited to
CRISPR–Cas9 screens because there
is only one copy of any given gene to
edit. We used the eHAP cells to ex-
amine the mechanisms of resistance
to 6-thioguanine (6-TG), a purine an-
timetabolite that is used in the treat-
ment of leukaemia. The biology of the
DNA mismatch repair (MMR) system
and factors that mediate resistance to
6-TG have been extensively studied
and as such provide an excellent par-

CoverStory
adigm to test the power of CRISPR–
Cas9 resistance screens in haploid
cells. eHAP cells were infected with
the whole genome GeCKOv2 library
and were exposed to either 500 nM
6-TG or vehicle control and main-
tained in culture to allow sgRNA en-
richment and depletion to occur. As
expected, NGS analysis revealed that
sgRNAs targeting MLH1, MSH2 and
MSH6, three genes that encode MMR
proteins, were enriched in the screen
(Branch et al., 1993; de Wind et al.,
1995, Abuinet al., 2000, Buermeyer-
et al., 1999). To validate these targets
as 6-TG resistance factors, MLH1
and MSH6 knockout HAP1 cells were
generated using a CRISPR–Cas9
approach. These cells were able to
proliferate in the presence of 6-TG
unlike the parental cell line. Thus,
CRISPR–Cas9 approaches were used
to both identify the mechanisms of
resistance and to validate them.
The future looks bright
CRISPR–Cas9 is a fast moving
technology that has been embraced
across the board. As discussed above,
it has been used to successfully iden-
tify mechanisms of drug resistance
in whole genome screens, but its
applications extend further into ani-
mal model generation and genetic
therapies. Its use, particularly in hu-
mans, is the subject of much debate
that looks set to continue for years
to come. However, in terms of drug
discovery, CRISPR–Cas9 technolo-
gies look poised to replace RNAi as
a new avenue for more effective drug
discovery. Thanks to NGS, we are
starting to catalogue the plethora of
mutational changes that occur in the
genome of any cancer cell. With this
knowledge comes potential – novel
mutated genes and the proteins that
they encode, are candidates for prog-
nostic markers and/or new drug tar-
gets. With the ability to rapidly engi-
neer cells (and animal models) using
CRISPR–Cas9 technologies, the gen-
eration of robust models needed for
improved target identification and
validation promise to be attainable.
BS
The generation of
robust models needed
for improved target
identification and
validation promise to
be attainable.

CoverStory
Triumph of high
precision parallel
bioreactors over
conventional systems
D. Muruganand
PhD., Vice President – Marketing, Eppendorf India, Chennai
Scientists
and
investors are
looking forward
to shorter
timeframes in
getting results
and the product
of interest
launched in
the market
respectively
T
he biopharma in-
dustry is growing
steadily at a sig-
nificant pace and
so are their invest-
ments in research
and development. Investment in
biologics like vaccine, biosimilars,
novel biopharmaceuticals, cell and
gene-based therapeutic products
are seeing a never before trend.
The stakeholders, both scientists
and investors, are looking forward
to shorter timeframes in getting
results and the product of interest
launched in the market respec-
tively. As these processes involve
cell culture or microbial fermenta-
tion, the need for dedicated mini-
bioreactor systems for process de-
velopment and critical parameter
optimizations in low volume ranges
are certainly creating interest com-
pared to the conventional fermen-
ters and bioreactors. With time
being very critical, the single use
vessels are also gaining more at-
tention over autoclavable formats
among the biopharma users.
From conventional
shake flasks to parallel
bioreactors
While initial bioprocess develop-
ment involving microbial or cell
culture involves several steps like
cell line optimization, clone selec-
tion, screening for media and feed
components along with other pro-
cess conditions, conventional shake
flasks are still used foroptimizing
these early steps. Though widely
used, shake flask formats only al-
low identifying temperature, am-
bientgas mix and agitation rates-
but pose limitation upon reaching
scalable levels with respect to the
industry standard monitoring and
control requirements. Critical pro-
cess parameters like pH, dissolved

CoverStory
oxygen (DO), gas flow rates and feed
schedules of media components are
beyond the capabilities of shake flask
format. Moreover equipment used
for screening or optimization in the
earlier steps should mimic the physi-
cal and mechanical characteristics
of production scale reactors to the
greatest degree possible, to ensure
consistency throughout development
phases. The parallel bioreactor sys-
tem provides all essential features in
a compact and comprehensive design
with flexibility to optimize and un-
derstand parameters that influence
growth kinetics, productivity, prod-
uct quality and stability.
Parallel bioreactors over
the micro/mini bioreactor
Though micro and mini bioreac-
tor systems address the basic needs
of media selection and optimiza-
tions they still do not support when
it comes to scalable proportions
and concerns over unconventional
formats are not uncommon. Lower
volume by itself seems to limit for
applications where the processes
requirements are not flexible. Feed
rates, sampling volumes to mention
a few could be mandatory in these
critical steps of characterization or
optimization. Hence selection of an
ideal system for lower volumes is no
different from the standard volumes
when it comes to the expectations of
the process outcome.
Expectations in a parallel
bioreactor system
With more manufacturers getting
into this space expectations also
grow from the user end. Hence the
demand for compact, comprehensive
and flexible system to adapt to pres-
ent and future needs is on the cards.
While deciding the number of vessels
the primary requirement starts with
a compact and less space occupying
system. But when coming to the pro-
cess needs features like flexibility for
upgrades to enhance or extend the
configuration to meet evolving needs,
minimum level of scalability in work-
ing volumes to establish proof of
concepts, possibility for seamless in-
tegration to downstream equipmen-
tare certainly the priorities. Above all
a simple and user friendly superviso-
ry control and data acquisition (SCA-
DA) software convenient for data ac-
quisition, monitoring and processing
becomes mandatory.
Parallel bioreactors
from Eppendorf
DASGIP parallel bioreactor systems
for microbial or cell culture applica-
tions from Eppendorf combine the
advantages of small working volumes
with the full functionality of indus-
trial bioreactors. The modular design
allows expanding the system capa-
bilities in 4,8,12 or 16 parallel vessels
format controlled by single operating
system. The vessels are the industry
standard stirred tank reactors with
different workings volumes ranging
from 60 mL to 3.8 L.
The modular system provides the
flexibility to configure to the needs
of user with respect to number of
pumps, gases and their flow rates.
The availability of single use vessels
of different volumes have provided
users the flexibility to choose be-
tween autoclavable and single use
vessels in both microbial and cell cul-
ture applications.
DASBOX parallel mini bioreactor sys-
tem for microbial or cell culture has
the option to use a dedicated vessel
volume with working volume rang-
ing from 60-250 mL. These systems
are also designed to operate in mod-
ules of 4, 8, 12 or more vessels.With
both autoclavable and single use ves-
sel formats available, the user has the
choice to select. Availability of Photo-
synthetic light module can make it a
convenient choice for users working
either with plant cells or for biofuel.
Both DASGIP and DASBOX sys-
tems can be calibrated in parallel for
pumps and sensors making the ves-
sels perform as replicates. Though
designed for parallel reactions, these
can also be controlled independently
for maintaining completely different
parameters.
DASGIP control software allows par-
allel monitoring, data capture with
online analysis options. Combined
with other software options, the
system can be integrated with third
party equipment like metabolite ana-
lyzer, Raman spectrometer etc. The
DAS ware software platform pro-
vides larger integration and analysis
flexibilities like Design of Experi-
ment (DoE), remote monitoring and
controlling, communicating with
third party OPC compliant systems
and morwwe. BS
PARALLEL BIOREACTOR SYSTEMS

CoverStory
Single use micro
scale bioreactor
enables higher
productivity
Dr Barney Zoro
ambr 15 Product Manager, Sartorius-Stedim Biotech, Royston, UK
A strategy
for reducing
manufacturing
COGs is to
use advanced
automated
micro and mini
bioreactor models
to improve
upstream
cell culture
productivity
W
o r l d w i d e
sales of bio-
logic drugs,
including
monoclonal
antibodies
(mAbs), fusion proteins and thera-
peutic enzymes now exceeds $120
billion per year. These therapies
cost more than small molecules,
in part because they are more ex-
pensive to manufacture. A strategy
for reducing manufacturing COGs
(cost of goods) is to use advanced
automated micro and mini biore-
actor models to improve upstream
cell culture productivity by select-
ing better clones and enabling more
efficient optimisation of media, feed
and culture conditions.
Traditionally, cell culture develop-
ment for bioprocessing begins with
screening to find clones that express
the most protein. This is usually per-
formed in small volumes of 0.1mL
to 6mL using a multiwell plate for-
mat. Because of the need to conduct
large numbers of experiments this
has resulted in the development of
systems based on 24 well single-
use multiwell plate. These have the
advantage of being quick and easy
to set up and use and because the
multiwell plate are pre-sterilised
there is no pre-process preparation
and as they are single-use there is
no post-run cleaning. Some of these
multiwell plate systems do provide
monitoring and some control of
dissolved oxygen (DO) and pH but
have the drawback that they do not
mimic the sparging or stirring ac-
tion of a large scale bioreactor as
they rely on shaking for mixing. Ad-
ditionally, they do not provide auto-
mated feeding and have a working
volume of less than 6mL, which lim-
its the amount of analytical testing
possible.
Clone selection and early process
development to identify the most
productive clones and define op-

CoverStory
timal media or culture conditions is
typically performed in shake flasks
with two or three top clones carried
forward for evaluation in bench top
bioreactors. Using shake flasks and
bench top bioreactors is very labour
intensive and as they are generally
made of glass, require time consum-
ing pre and post-process cleaning
and sterilisation for every experi-
mental run.
Shake flasks provide no active control
of pH and DO, relying on the buffer-
ing capacity of the media and the gas
environment of the incubator. The
mixing environment is unlike that in a
bioreactor as there is no impeller. Ad-
ditionally, shake flasks are often ma-
nipulated by hand, making it difficult
to perform nutrient feeding or sam-
pling without introducing variability.
Hence, the use of shake flasks can of-
ten result in different cell growth and
titre profiles to those seen after scale-
up in a bioreactor. Data published
in Cytology of a study at Genentech
demonstrates that when cultured in
shake flasks, Chinese Hamster Ovary
(CHO) clones expressing mAbs do
not show comparable culture perfor-
mance with those grown in 2L bench
top bioreactors.
Using bench top bioreactors does
mimic the sparging and stirring ac-
tion of a large scale bioreactor but
they require considerable amount
of time for set-up, operation and
post-experimental cleaning and ster-
ilisation. Therefore, the amount of
available resource often limits use
of bench top bioreactors requiring
that researchers have to select only
their top clones to test in this way.
This can lead to the final choice of
clone sometimes performing sub-
optimally upon scale-up, adversely
affecting yield and titre. If a larger
number of runs could be performed
during clone selection under condi-
tions which are representative of the
scale-up bioreactor environment,
then it should be possible to isolate
a better performing clone for use in
manufacturing and potentially save
thousands of dollars in manufactur-
ing COGs.
To meet the need for a single-use bio-
reactor model that provides compa-
rable mixing, gassing and sampling
parameters to be used in place of
shake flasks and bench top bioreac-
tors, the advanced micro and mini
scale bioreactor systems, ambr 15 and
ambr 250 (Sartorius-Stedim Biotech)
have been developed. These integrat-
ed systems combine 10-15mL or 100-
250mL single-use bioreactor, with an
automated liquid
handling work-
station and dedi-
cated control and
analysis soft-
ware. Critical to
the use of these
systems as bio-
reactor models
is the geometric
similarity to larg-
er bioreactors
and that their
contents are
stirred by an im-
peller and gases
can be supplied
by sparging. In addition, the software
control systems and integrated single
use sensors enable these systems to
control the culture conditions in a
similar way to large scale systems en-
suring scalability.
Each workstation maintains aseptic
conditions using a HEPPA filtered
environment (ambr 15 can be in-
stalled in a standard biological safety
cabinet and the ambr 250 includes
an integrated system) and provides
independent parallel control of either
12 or 24 (ambr 250), 24 or 48 (ambr
15) bioreactors. The workstation con-
trols the stir speed, gas supply and
temperature and also provides liquid
handling automation functions for
the bioreactors, each of which can
have its own medium, feed, inoculum
and sampling strategy. Each bioreac-
tor also incorporates sensors for real-
time measurement and bioreactor-
specific automated control of DO and
pH and set points.
A major contract research organisa-
tion (CRO) compared the timelines
for clone selection and early process
development of a mAb expressing
(CHO) clone using shake flasks and
bench top bioreactors with the auto-
mated micro bioreactor. The results
showed that with reusable shake

CoverStory
flasks and bench top bioreactors,
clone selection and early process
development took around 22 weeks,
whereas using the single-use micro
bioreactors and a confirmatory run
in a reusable bench top bioreactor
ambr15 operators examining full 96 well plate Picture
this was reduced to six weeks.
Single-use micro and mini bioreac-
tor technology can provide an ac-
curate prediction of cell growth and
protein titre achieved in bench top
bioreactors. Setting up and running
reusable shake flasks and bench top
bioreactors is manually intensive,
while the fully automated single-use
micro and mini bioreactor is more
convenient, taking much less time to
set-up and run, as well as requiring
no time consuming post run cleaning
and sterilising. Thus clone selection
and early process development can
be performed rapidly and efficiently,
increasing the number of clones that
can be evaluated by up to ten fold.
This improves the chances of select-
ing a clone with optimal growth and
protein expression. The automated
system makes it easy to implement
DoE into the work flow and the geo-
metric similarity of the platforms re-
duces the risks for scale-up to larger
single-use pilot and manufacturing
scale stirred bioreactors, reducing
time-lines and saving cost. BS

CoverStory
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CoverStory
AcquityQDa:
Separating
beyond question
Manu Grover
Product Manager-Pharmaceutical Market, Waters India.
One of the
complicated
process
in analytical
industry was
handling of
Mass detection
technologies.
The research
is still on to
find the most
sensitive Mass
spectrometer or
detector.
W
hen Albert
E i n s t e i n
forged the
b e d r o c k
t h e o r y
of mod-
ern physics 100 years ago, he had
no computer,nointernet and few
homes had telephones. Yet it took
one of the most sophisticated sci-
ence tools ever built, at a cost of
hundreds of millions of dollars,
to prove an idea the scientist had
crafted with little more than paper,
a fountain pen, hard work and a
mind sharper than most. Recently
physicists announced they had de-
tected gravitational waves, hitherto
a key unproven element of Ein-
stein’s general theory of relativity.
It is not always the complicated pro-
cess work better but simple tools
and process are faster and accurate
too. Waters also with same philoso-
phy started searching for simple
answers for complicated questions.
One of the complicated process in
analytical industry was handling of
Mass detection technologies. The
research is still on, to find the most
sensitive Mass spectrometer or de-
tector. Waters thought differently
and focussed on simplifying the
usage of the Mass detector tech-
nology so that it reaches to masses
and today we have world’s smallest,
sensitive enough, very robust, and
highly user friendly Mass detector
– AcquityQDa.
The product istrulyan industry
changing technology. The idea was
to empower and enable chromatog-

CoverStory
ra-
phers
with ac-
cessible mass
data, without
the training, without the complex-
ity, without extensive compound-
specific optimisation. This is realised
through the AcquityQDa detector
which is now revolutionizing prac-
tices within laboratories in India
and globally. Within India we have
more than 20 companies using the
technology in different areas of RD,
Quality Control, Drug Discovery etc.
The vision of the AcquityQDa was
born through the unmet need of the
analytical scientists. Today many
prestigious scientists and multi-na-
tional companies are thrilled with its
impact on quality of data. The QDa
has been recognized throughout the
industry both in India and globally
garnering very positive reviews and
winning multiple awards for innova-
tion. AcquityQDa was listed as one of
the top 15 innovative products of the
year.
Increased efficiency is coming from
dramatic innovation. The result of
over 30 patented Waters innovations,
this the only mass detector that fits
on top of your instrument stack. Us-
ing less bench space and less energy
than a traditional mass spectrometer,
it fits easily within your existing lab
set up
as part of your
regular workflow. Even
most cleaning and routine mainte-
nance have been innovated away,
maximizing your uptime. This is fun-
damentally different from any expe-
rience one would have had with MS.
In any analytical development we
majorly rely on UV/PDA detector as
detector of choice and live with the
limitations of same. To have more
confidence in data, to understand
the development process better and
to resolve the complex cases of mass
balance we need to have orthogonal
analytical detectors like AcquityQDa
in our development process. The
usage of the detector ensures confi-
dence in the data and hence ‘Right
time-first time’.
The challenges in UV/PDA based
developments can be resolved using
this orthogonal detector AcquityQDa
Mass Detector, which have been pur-
posefully designed to enable analysts
to readily incorporate mass detection
within a UV/PDA chromatographic
workflow. The simplicity of this Sin-
gle Quadrapole Mass detector is such
that it can be handled easily by the
chromatographers who have no MS
training and are only UV/PDA users.
AcquityQDa has the quickest start
time, once switched on, the detector
is ready to use in less than 25 min-
utes. AcquityQDa through Empower
CDS software can enable scientists to
do tasks like peak tracking, identify-
impurities/peaks, analyze non-chro-
mophoric impurities, understand-
mass-balance related issues, perform
MS finger printing, confirm peak pu-
rity data, etc.
With recent interest of many organi-
zations in Biologics and Biopharma-
ceuticals, AcquityQDa has emerged
to be quite useful in these areas as
well. AcquityQDa enables greater
selectivity, faster – high throughput
methods, and mass confirmation for
greater certainty and productivity in
routine ‘Glycan monitoring’.
AcquityQDa is being utilized by
many organizations to monitor pep-
tides over a wide molecular weight
range. The addition of mass detec-
tion allowed scientists to monitor
and quantify peptides with greater
specificity. AcquityQDa expands the
sensitivity currently available with
optical only workflows. The addition
of AcquityQDa to existing workflows
allows scientists to selectively detect
and monitor co-elution species. And
perhaps most importantly, Acqui-
tyQDa works with both TFA and FA
based separations.
Recent publications like “HILIC-MS
Determination of Genotoxic Impu-
rity of 2-Chloro-N-(2-Chloroethyl)
Ethanamine in the Vortioxetine
Manufacturing Process” by Zentiva
(Sanofi), “Implemenation of a single
quad MS detector in high-through-
put transdermal research of plant
extracts” by University of Ghent and
‘‘A novel compact mass detection
tool for the open access (OA) envi-
ronment in drug discovery and early
development” by Merck use Acquity-
QDa technology and hence exhibiting
the potential of this simple and pow-
erful tool. BS

CoverStory
Exploring new
frontiers in biological
science using Mass
Spectrometry
Sharad Mishra
Sr. Product Manager, life sciences mass spectrometry,
Thermo Fisher ScientificScientists
and
biologists
face many
challenges
in functional
biology studies
that require
the observation
of proteomes
over many time
points
F
uture of bioscience
through its potential
utility in RD where
pharmaceutical in-
dustries increase in-
vestment to achieve
discovery of novel compounds.
This technology will continue to
drive high-throughput screening of
candidate molecules together with
advances in ‘omics’ technologies
(genomics, transcriptomics, pro-
teomics, metabolomics) and bio-
marker identification. Innovation
is shrinking industrial machines
and medical devices to the scale of
atoms and molecules. Mass spec-
trometry is one of the important
and versatile tools that will drive
the
Mass Spectrometry is used in in-
dustrial and academic fields for
both routine and research purpos-
es. Today, there is no single area of
experimental science where mass
spectroscopy is not being used. It is
used to understand the fundamen-
tal atomic and molecular processes
and, at the same time, those of im-
mediate relevance to events within
cells. As a technique, it helps to
control processes in chemical and
biological industries, diagnose dis-
eases, discover new drugs, protect
the environment and explore mys-
teries of nature.
Scientists and biologists face many
challenges in functional biology
studies that require the observa-
tion of proteomes over many time
points, precise spatial distribution
of proteins and different cellular

CoverStory
states. These issues translated into
the analytical challenge of perform-
ing reproducible and precise quan-
tification of a few selected biological
components in the presence of very
complex background.
One of the major challenges in pro-
teomics is the quantification of low
abundance proteins and peptides
of biological relevance such as tran-
scription factors or low stoichiometry
post translational modified proteins.
The quantification of these analytes
of interest is complicated by the very
large dynamic range observed for cel-
lular protein expression, especially in
humans. With the development of
new generations of mass spectrom-
etry platforms providing high resolu-
tion and multiple detector versatility,
new strategies are available to push
the limits of quantification.
This new technology ensures that
scientists don’t miss anything in
their area of research and provides
a strong platform, combining next-
generation screening techniques
with advanced targeted methods for
protein quantitation. It is designed
to expand researchers’ capabilities
in advanced proteomics and me-
This new technology
ensures that scientists
don’t miss anything in
their area of research
and provides a strong
platform
tabolomics applications, including
targeted, data-independent acquisi-
tion (DIA) and top-down analyses
with the industry’s highest level of
sensitivity. This delivers more com-
plete sequence coverage and allows
scientists to perform more inclusive
analyses.
On January 27, 2016, Thermo Fisher
Scientific’s Orbitrap Fusion Lumos
Tribrid Mass Spectrometer received
the SelectScience Scientists’ Choice
Award for Best New Drug Discov-
ery Product of 2015. This award cel-
ebrates the new technologies that
made the biggest impact in drug dis-
covery and development research in
2015. The awards are unique in this
industry as they empower scientists
to nominate and vote for their favor-
ite new product, allowing them to
have their say about which manufac-
turers have truly enabled their work.
We’re seeing first hand how Orbi-
trap mass spectrometry is driving the
future of bioscience, helping scien-
tists push the limits of quantitation
and protein characterization further
and faster. It is ideal for laborato-
ries that require more extensive and
more profound analytical informa-
tion from their sample, especially
lower limits of detection and better
sequence coverage when characteriz-
ing proteoforms, which was not pos-
sible with other high-resolution mass
spectrometry systems.
This technology also enables scien-
tists to:
 Confidently quantify low-level
analytes, low atomic LOQ in
nLC analysis and fg in high flow
analysis;
 Be more selective about which
instruments they perform their
MS/MS experiments on;
 Characterize intact proteins with
top down on LC time scale, which
means lower detection limits and
higher throughput; and
 Elucidate structures more thor-
oughly and easily by using any
fragmentation mode, at any stage
of MSn analysis, with detection
by either analyzer, which maxi-
mizes structural information from
metabolites, glycans, PTMs, and
sequence polymorphisms. BS

BioTalk
C
ell Culture Company is a US based Contract
Manufacturing Organisation that manufactures
automated single-use perfusion bioreactor sys-
tems and provide custom manufacturing ser-
vices for diagnostic and therapeutic mammalian protein
production.Christiaan Engstrom, in an e-mail interview
with BioSpectrum Asia, shares his thought on the pros-
pects of biologics manufacturing.
What are new opportunities in biologics
manufacturing for CMOs?
A Biosimilars are opening up new opportunities for
CMOs as hundreds of drugs have already come off
patent and will continue to do so over the next decade or
so.This transition has changed the focus of many drug
manufacturers back to innovation and has augmented
traditional manufacturing facility needs as multi-product
facilities trend upwards.
Pharma companies are definitely interested in investing
in biologics, especially as the patient population is taking
a more active interest in their treatment.The population
is demanding new, more targeted therapies,which means
that large molecule drugs will remain on an upward tra-
jectory.Additionally, patients and physicians will be able
to choose from multiple commercial sources for drug
products,which will add a new element of competition.
What are the benefits of single-use technology
and is it getting more popular?
A As manufacturers look to increase productivity and
decrease facility footprint and cost,single-use tech-
nologiespresent an easy to implement solution.Whenever
a facility is producing multiple products, cross-contami-
nation becomes a serious risk.Single use nearly elimi-
nates this risk through the disposal of all product contact
material.Users can also expand the footprint of their fa-
cilities more drastically and rapidly,because of the flexi-
ble skids, and eliminate clean-in-place or steam-in-place
stainless steel piping—not to mention the tonnesofwaste
that come with them.
Single-use technologies have already made a huge impact
on the way this industry operates over the last decade.
Biosimilars are opening
up new opportunities
Mr Christiaan Engstrom
President, Cell Culture Company
Interview

BioTalk
We fully expect that the trend towards multi-product fa-
cilities will eventually become a standard,meaning that
single-use technologies will continue to be a solution of
choice for the industry.
Do you have plans to expand customer base in
Asia?
A Definitely, and, in fact, we already work on certain
levels in this market.AtCell Culture Company, our
goal is to ensure that customers have a reliable, global
partner.Asia is a critical market of focus for us,and one
that we look forward to expandinginoverthe next five
years.
What are the challenges in supply chain and
cross-border shipments?
A Most biologics are living and highly perishable—
unless they are lyophilized—sotimely delivery by
couriers is critical to ensure the product is not lost due to
improper cold handling. Global distribution of living
products further complicates this challenge.The level of
cold and supply chain support needs to be exceptional to
ensure product viability.
Right now, we see that most countries or unions are en-
forcing individual established policies, but this is not
enough.Webelieve that the industry will continue driving
towards harmonisation of global importation to address
this critical challenge that has now become industry-wide
with the uptick in large molecule drug production.
As a new entity, what are the immediate plans
of Cell Culture Company?
A We see many opportunities for growth, which is
why we are launching C3. Our initial focus will be
on enhancing and growing our core businesses:our cus-
tom GMP contract production BioServices, single-use
perfusion bioreactor portfolio,and National Cell Culture
Center offerings.Our goal is to leverage our30+years of
experience in delivering custom GMP production servic-
es from preclinical to commercial stages to the
diagnostic,therapeutic and animal healthcare industries.
We want to be recognised for being a trusted partner that
delivers innovative, high quality products and services
that control costs and increase speed to market.
What are the factors do you attribute to for the
growth of outsourcing industry in biopharma
sector?
A As the drug industry shifts back to innovation, with
a greater focus on large molecule development,
manufacturing outsourcing has almost become a neces-
sity.Drug makers have to focus their resources on devel-
oping the lifesavingtherapies that the market is demand-
ing. And, as biologics become more popular, batch sizes
have drastically decreased since the days of the block-
buster drugs.
A traditional, highvolume manufacturing facility no lon-
ger retains the same value for many drug manufacturers.
And, as technology advances continue to extend the shelf
life of biologics, onsite manufacturing becomes even less
attractive.There are numerous other advantages to out-
sourcing, including decreased risk and cost by removing
operators from the equation.
Of course, that makes the importance of selecting the
right contract manufacturing partner crucial. This is
where C3 sees our greatest opportunity—in being an ex-
ceptional, long-term instruments and bioservices partner
to our customers.
How should a CMO ensure the interest of
the sponsor companies at the available
infrastructure and capacity?
A This is an everevolving question as outsourcing be-
comes more commonplace.Eventually, it all comes
down to having proper documentation and full manufac-
turing transparency—not only between partners,but also
to meet and exceed the various regulatory expectations.
Beyond that, there is such a great element of trust in
an outsourcing partnership.The most successful CMOs
will have clearly defined supply agreements,including
agreedupon transfer methods and details of how the sup-
plier plans to deliver exceptional supply chain security.
At the end of the day, the value of your product does not
matter if your customer cannot get it.
There is a great deal of responsibility placed on the CMO
to really know their market and act as a guide for the cus-
tomer every step of the way. BS
Amrita Tejasvi

BioNews
Korea’s ImmunoMet
raises $5.2 mn
Korea-based ImmunoMet Therapeutics, a biotech-
nology company developing innovative drugs for the
treatment of cancer, has raised $5.2 million in a Se-
ries A financing led by Mirae Asset Venture Invest-
ments with participation from Aju Tech, GNTech, and
MetaVest.
ImmunoMet Therapeutics is a development-stage
biotechnology company, focused on the development
of innovative oncology products.The company’s novel
technology is designed to disrupt cancer cell growth
and enhance anti-cancer immunity and may be used
in a broad range of difficult-to-treat cancers.The com-
pany’s lead compound, IM156, for the treatment of
glioblastoma (brain cancer) is expected to enter Phase
1 clinical development in the second half of 2016.
The primary use of these proceeds will be to fund the
company’s research and clinical development pro-
grams, establish its worldwide headquarters in Hous-
ton and for general corporate purposes.
Biovest to spin off
CMO business
Biovest International has decided to spin off its in-
strument and contract manufacturing offerings into
a single wholly-owned subsidiary named Cell Culture
Company.
Cell Culture Company will supply automated single-
use perfusion bioreactor systems and custom mam-
malian cell and protein manufacturing services to the
diagnostic, therapeutic, and animal healthcare indus-
tries.
Since the late 1990s, Biovest’s primary focus has
been the commercialization of personalized immu-
notherapies. That work will continue under the Bio-
vest name.”The spin-off of Cell Culture Company will
ensure that our instrument and CMO customers will
be better served through increased focus and invest-
ment,” said ChristiaanEngstrom, president, Cell Cul-
ture Company President.
Medical device firms open to
invest on RD: KPMG survey
Medical device manufacturers are investing heavily in re-
search and development (RD), and are shifting their in-
novation strategies from incremental innovation towards
achieving breakthrough innovation, according to Global
Manufacturing Outlook survey conducted by KPMG.
Almost a quarter of all respondents say they spend more
than 6 percent of revenueon RD in the last two years,
according to a further analysis of a recent KPMG Inter-
national Global Manufacturing Outlook 2015 survey.This
level of investment and distinct drive for breakthrough
innovation is in contrast to the other manufacturers
polled in other sectors.
In fact, leading medical devices manufacturers are also
collaborating with a much broader range of players than
before.The report found 80 percent of respondents seek-
ing “partnerships rather than in-house efforts” in the pur-
suit of innovations.
Tan WahYeow, Head of Asia Pacific Healthcare practice
at KPMG in Singapore said, “More than other manufac-
turing sectors,medical devices have a special stake in in-
novation. The nature of the business requires companies
to elevate their performance to offer better life-enhancing
and life-saving technologies.
Medical devices companies need to embrace collabora-
tive innovation with a broader range of partners such as
suppliers, development partners and healthcare provid-
ers to develop product customisation to markets for an
‘in-country, for-country’ business model.
Ajay Kumar Sanganeria, Life Sciences Partner at KPMG
in Singapore said, “It is imperative that medical device
companies, especially smaller, low-cost manufacturers in
Singapore develop breakthrough products through col-
laboration to stimulate growth and remain competitive in
the industry. Compared to larger companies, these com-
panies are more adaptable, better able to identify market
niches and have more innovative potential.”

BioNews
China to account for half of Hep B drug sales by 2024
China will remain the largest ma-
jor hepatitis B market over the next
decade, rising from just under $923
million in 2014 to over $1.4 billion by
2024, representing a Compound An-
nual Growth Rate (CAGR) of 4.4%,
according to research and consulting
firm GlobalData.
The company’s report, which cov-
ers the eight major markets (8MM)
of the US, France, Germany, Italy,
Spain, the UK, Japan and China,
states that China will continue to
dominate the hepatitis B treatment
space, as its market share rises from
38.8% in 2014 to 47.2% by 2024.
DrDaian Cheng, GlobalData’s Ana-
lyst covering Infectious Disease, says
this hepatitis B market trend will
be largely down to natural popula-
tion growth and China’s huge and
increasing drug-treated population,
which currently makes up 80% of
treated cases across the 8MM.
Dr Cheng adds: “China’s proportion
of treated cases is much higher than
its market share because hepatitis
B therapeutics cost much less com-
pared with other regions.Indeed, it is
the sheer increase in the number of
drug-treated patients that will drive
market growth.
“The projected increase of patients
alone, nearly 3,00,000 between 2014
and 2024, is much more than the to-
tal number of treated patients in the
US, which is around 1,00,000. Thus,
the increase in therapeutic sales will
be considerable and China will hang
on to its market dominance, even
with lower drug prices.”
Despite the relatively high rates of
hepatitis B among the Chinese popula-
tion, infants are screened for the infec-
tion as part of health checks at birth,
and at various points throughout their
lives, a practice which is mostly orga-
nized by schools and employers.
APAC’s Alzheimer’s market to surpass $5 bn by 2021
The Asia-Pacific (APAC) Alzheim-
er’s disease market will grow from
$3 billion in 2014 to $5.1 billion in
2021,representing a robust Com-
pound Annual Growth Rate of 7.9%,
according to business intelligence
provider GBI Research.
The company’s latest report states
that the main driver of this im-
pressive growth,which will oc-
cur across the APAC countries of
India,China,Australia and Japan,will
be rising and aging populations,
as Alzheimer’s disease is significantly more prevalent
among the elderly. Additional market drivers include bet-
ter diagnostic techniques, improving health awareness,
special healthcare programs, health insurance coverage,
and increasing treatment affordability.
MsGayathriKanika, Analyst for GBI Research, says: “An
example of healthcare reforms is the Japanese govern-
ment’s recently approved plan to increase the number of
nurses and care workers in the country’s healthcare sys-
tem by 2025,in order to help patients access and inter-
pret information about their health, thereby improving
knowledge and diagnoses of Alzheimer’s.
“Across the APAC region, the expansion of health insur-
ance coverage will increase access
to healthcare, also leading to a rise
in Alzheimer’s diagnosis and higher
treatment rates.” In terms of the cur-
rent Alzheimer’s pipeline, there are
a number of latestage products with
the potential to be approved and
launched in APAC countries during
the forecast period.
These include first-in-class Beta-site
Amyloid precursor protein Cleaving
Enzyme (BACE)1 inhibitors and pas-
sive immunotherapies.
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BioNews
Baxter initiates clinical trial for
home hemodialysis system
Baxter International
has announced the
enrollment of the first
patient in a US clini-
cal trial for VIVIA, an
investigational home
hemodialysis (HD)
system being devel-
oped by Baxter and
DEKA Research
Development Corpo-
ration.
The trial is designed to study more frequent, extended dura-
tion nocturnal home HD therapy (High Dose HD), which will
be performed in dialysis facilities as well as the home setting.
The study is assessing safety of the product and adequacy of
dialysis.
The VIVIA investigational home hemodialysis system in-
cludes an integrated water purification module, safety sensors
and one-button fluid infusion. The investigational system also
features SHARESOURCE, Baxter’s two-way connectivity plat-
form that allows physicians and nurses to monitor patients’
historical treatment results remotely.
Synbiosis introduces the aCOLyte 3 HD
high resolution colony counter
Synbiosis manufacturer of auto-
mated microbiological systems
has introduced the aCOLyte 3
HD automated colony counter for
microbiologists to quickly and ac-
curately count colonies of all sizes
and colours.
The new aCOLyte 3 HD colony
counter, features a high resolution
megapixel CCD camera for accu-
rate detection of different coloured
microbial colonies,even those
as small as 0.1mm.The system’s
software can analyse pour, spread
andspiral plates of up to 90mm, gen-
erating full-colour plate images and
precise count in seconds.The results
can be directly transferred to Excel
and other software packages to avoid
keying and scanning errors, guar-
anteeing accurate GLP compliant
reporting and full data traceability
every time.
“Countinghundreds of micro-
bial colonies is time consuming
and can generate data that var-
ies between different microbi-
ologists as it is a tiring and er-
ror prone task,”comments Kate
George, Divisional Manager at
Synbiosis,”we’re confident this
new colony counter provides af-
fordable automation, which will
improve count accuracy, as well
as increase productivity in any wa-
ter, food or environmental lab that
installs an aCOLyte 3 HD.”
Gilead’s cancer drug
under FDA scrutiny
US Food and Drug Administration has raised
alarm for Gilead Science’s cancer medicine
Zydelig (idelalisib) due to incoming reports of
an increased rate of adverse events, including
deaths.
According to FDA, Gilead Sciences has decided
to halt six clinical trials in patients with chronic
lymphocytic leukemia, small lymphocytic lym-
phoma and indolent non-Hodgkin lymphomas.
Zydelig is currently approved by the FDA for the
treatment of relapsed chronic lymphocytic leuke-
mia, in combination with rituximab, in patients
for whom rituximab alone would be considered
appropriate therapy due to other co-morbidities;
relapsed follicular B-cell non-Hodgkin lymphoma
in patients who have received at least two prior
systemic therapies; relapsed small lymphocytic
lymphoma in patients who have received at least
two prior systemic therapies.

BioNews
Celsion launches cancer
drug trial in China
Celsion Corporation, a fully-integrat-
ed oncology company focused on the
development of a portfolio of innova-
tive cancer treatments,has launched
OPTIMA Study in China.
The OPTIMA Study is the company’s
global pivotal, double-blind, place-
bo-controlled trial, evaluating Ther-
moDox, Celsion’s proprietary heat-
activated liposomal encapsulation
of doxorubicin, in combination with
radiofrequency ablation standard-
ized to 45 minutes (sRFA) versus
sRFA alone to treat newly diagnosed
patients with (hepatocellular carci-
noma) HCC.
The Phase III OPTIMA Study is ex-
pected to enroll up to 550 patients
globally, and has been successfully
enrolling patients at 50 clinical sites
in 12 different countries in North
America, Europe and Asia Pacific.
In December 2015, the company an-
nounced that it had received a Clini-
cal Trial Application (CTA) approval
from the China Food and Drug Ad-
ministration (CFDA) to conduct the
ongoing Phase III OPTIMA Study at
up to 20 additional clinical sites in
China. The company aims to enroll
more than 200 patients in the Chi-
na territory, the minimum number
required by the CFDA to file a New
Drug Application (NDA), assuming
positive clinical results.
Pharma Engine gets TFDA nod
for pancreatic cancer drug
Taiwan based PharmaEngine has
receivedTaiwan Food and Drug Ad-
ministration (TFDA) approval of the
product license of ONIVYDE (irino-
tecan liposome injection, nal-IRI).
ONIVYDE is indicated, in combina-
tion with fluorouracil (5-FU) and
leucovorin (LV), for the treatment of
patients with metastatic adenocarci-
noma of the pancreas after disease
progression following gemcitabine-
based therapy.
There are two steps for the market-
ing approval of new drugs in Taiwan.
The first step is to assess whether
the chemistry, manufacturing and
controls,preclinical and clinical data
regarding the quality, safety and effi-
cacy are sufficient to issue the regula-
tory approval letter; and the second
step is to assess whether the product
labeling and package insert are sup-
ported by the new drug application
dossiers. Both steps are essential for
product sales in the Taiwan market.
“We are very grateful that the TFDA
accelerated the approval of the prod-
uct license in such an expedited man-
ner,” said CGrace Yeh, president and
CEO of PharmaEngine. “In addition,
we highly appreciate our license part-
ner, Merrimack Pharmaceuticals for
their total support during the review
period. Today marks a new era that
transforms PharmaEngine from a re-
search and development company to
a commercial pharma company.”
BioAgilytix
acquires IPM
Biotech
BioAgilytix, a leading provider of
contract bioanalytical testing ser-
vices specializing in large molecule
bioanalysis, has announced the ac-
quisition of IPM Biotech, a German-
based bioanalytical contract research
laboratory renowned for its expertise
in large molecule bioanalysis, partic-
ularly in the area of immunogenicity.
The transaction not only expands
BioAgilytix’saglobal footprint, with
IPM’s newly planned GLP and GMP
laboratory facility, but also brings on
board IPM’s rich immunogenicity,
pharmacokinetics (PK), and pharma-
codynamics (PD) expertise to com-
plement BioAgilytix’s world-class
capabilities in biomarkers, cell-based
assays, and immunogenicity phar-
macokinetics.
Each company has experienced at-
tractive organic growth through a
strong commitment to scientific qual-
ity and attentive customer service.To-
gether, they will offer this same rigor
of science and service to customers
across continents, with expanded
capabilities to support all phases of
large molecule global studies.

BioNews
Lupin completes its acquisition of GAVIS
Pharmamajor Lupin announced that it has completed its acquisition of pri-
vately held US based GAVIS Pharmaceuticalsand Novel Laboratories(GAVIS).
Lupin had announced the acquisition on July 23rd 2015.
GAVIS brings to Lupin a highly skilled US-based manufacturing and research
organization which would complement Lupin’s Coral Springs, Florida, based
RD center for Inhalation. GAVIS’s New Jersey based manufacturing facility
also becomes Lupin’s first manufacturing site in the US.
New Jersey based GAVIS is a privately held company specializing in formu-
lation development, manufacturing, packaging, sales, marketing, and dis-
tribution of pharmaceuticals products. GAVIS has 62 ANDA filings pending
approval with the US FDA and a pipeline of over 65+ products under develop-
ment. Seventy two percent of these filings pending approvals represent niche
dosage forms with 18 Para IVs and 8 FTFs products.GAVIS’s pending approv-
als address a market of over $9 billion.
The combined company will have a portfolio of over 120 in-market products,
over 185 cumulative filings pending approval and a deep pipeline of products
under development for the US. The acquisition creates the 5thlargest pipeline
of ANDA filings with the US FDA, addressing a $63.8 billion market.
AZ pact with China Medical System
for hypertension medicine
AstraZeneca announced it has entered into a licensing agreement with China
Medical System (CMS) Holdings for the commercialization rights in China to
its calcium channel blocker, Plendil (felodipine). Plendil was first approved in
China in 1995 for the treatment of hypertension or high blood pressure and in
2015 achieved product sales of $189 million.
Under the terms of the agreement,CMS will pay AstraZeneca $310 million
for the license to sell Plendil in China.AstraZeneca will maintain a significant,
long term interest in the future value derived from Plendil sales in China and
will manufacture and supply the medicine to CMS.AstraZeneca will retain the
global rights to Plendil outside China.The transaction does not include the
transfer of any AstraZeneca employees or facilities.
The licensing agreement for Plendil will close at signing and revenue from
the agreement will be reported as externalization Revenue in AstraZeneca’s
financial statements. The agreement does not impact AstraZeneca’s financial
guidance for 2016.
AstraZeneca has also entered into an agreement with CMS and its associated
company, Tibet Rhodiola Pharmaceutical Holding for the divestment of the
global rights to Imdur outside the US.
IBM, New York
Genome Center
to create cancer
data repository
At White House Precision Medicine
Initiative Summit, the New York Ge-
nome Center and IBM announced
that they are collaborating to create a
comprehensive and open repository
of genetic data to accelerate cancer
research and scale access to preci-
sion medicine using cognitive in-
sights from IBM Watson. Analyzing
this data alongside the medical com-
munity’s growing knowledge about
cancer could help accelerate the abil-
ity of doctors to deliver personalized
treatment to individual patients.
IBM and New York Genome Center
are working together to build the ca-
pacity to house the contributed data,
train Watson’s cognitive computing
capabilities for genomic analysis and
enable the Center’s member institu-
tions and other research collabora-
tors to sequence and analyze DNA
and RNA from patients’ tumors.
In the first phase of the project, the
two organizations will examine genet-
ic information from 200 cancer pa-
tients to compare how different types
of sequencing might impact possible
treatment options - examining whole
genome and whole exome sequenc-
ing as well as clinical panels currently
in wide use. Sequencing and clinical
data will be fed into Watson to ac-
celerate and focus reviews of massive
amounts of medical evidence.

BSA_April_2016

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