Lyophilization USA 2017

Introduction to Design of Experiments
13.30 - 17.30
Workshop Leader:
Perceval Sondag, Principal Statistician, Arlenda
BOOK BY 30TH JUNE 2017 AND SAVE $300
BOOK BY 29TH SEPTEMBER 2017 AND SAVE $100
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS
Wednesday 15th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
www.lyophilization-usa.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
@SMIPHARM
#lyousa
Implementation of Quality by Design principles
into lyophilization processes
08.30 - 12.30
Workshop Leader:
Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
REASONS TO ATTEND:
• Case studies and developments in scale up and technology
transfer
• New approaches to process understanding of using novel PAT
approaches and QbD principles
• Tackle challenges in freeze-drying high concentration biologics
• Explore strategies in technology transfer and scale up for
lyophilized products
• Discuss vapour pressure monitoring and controlled nucleation
• Gain an exciting insight into bulk lyophilization and automation
CHAIR FOR 2017:
• Andrea Weiland-Waibel, Managing Director,
Explicat Pharma GmbH
KEY SPEAKERS INCLUDE:
• Lokesh Kumar, Associate Scientist, Genentech
• Charlie Tang, Associate Director, Formulation
Development, Regeneron Pharmaceuticals
• Guido Schmitz, Global Head of Packaging &
Technology Innovation, Bayer Consumer Care
• Perceval Sondag, Principal Statistician, Arlenda
• Eric Munson, Professor, Pharmaceutical Sciences,
University of Kentucky
• Kelly Forney Stevens, Drug Product Development,
GSK Vaccines
• Melissa Lash, Scientist, Large Molecule Drug
Development, Johnson & Johnson
Optimizing lyophilization cycles through innovations
in formulation and process analytical technology
SMi presents the 3rd Annual Conference on...
Lyophilization USA
Renaissance Woodbridge Hotel,
Iselin, New Jersey, USA
CONFERENCE:
16TH - 17TH
WORKSHOPS: 15TH
NOV
2017
Sponsored by

Register online at www.lyophilization-usa.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join
the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Official Media Partners:
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
OPENING ADDRESS
9.10 Hydrogen Deuterium Exchange Mass Spectrometry for
formulation/process optimization in lyophilized solids
• Basics of hydrogen deuterium exchange Mass Spectrometry
(HDX-MS), for formulation and process optimization, will be
briefly discussed
• Impact of formulation parameters, i.e., protein: sucrose ratio,
type of stabilizer etc. will be discussed
• Impact of processing parameters, including controlled ice
nucleation and annealing, on stress stability will be discussed.
Correlation of HDX-MS data with stress stability would be
performed to evaluate rank ordering of the impact of
processing conditions
Lokesh Kumar, Associate Scientist, Genentech
9 50 Lyophilization process development, scale-up and technology
transfer strategies
• Traditional approaches for process design, scale-up, and tech
transfer
• Impact of lyophilizer design on lyophilization process transfer and
scale up
• Challenges that can occur when implementing plans for large
scale lyophilization
Charlie Tang, Associate Director, Formulation Development,
Regeneron Pharmaceuticals
10.30 Morning Coffee
11.00 Holistic approach to packaging and innovative design
• Case study on innovation in packaging of pharmaceuticals
• Challenges designing packaging that ensures patient safety
and meets regulatory requirements
• Relating consumer- friendly packaging to lyophilized products
Guido Schmitz, Head of Packaging & Technology Innovation,
Bayer Consumer Care
11.40 Assessing phase separation in lyophilized protein formulation
• Understanding how and when phase separation occurs
• Methods utilized to detect phase separation
• Impact of formulation components and process parameters on
phase separation
• Significance of phase separation in lyophilized formulations
Kelly Forney Stevens, Drug Product Development, GSK
12.20 Networking Lunch
1.30 Tempris – how wireless product temperature monitoring is used in
commercial lyophilization today
• Characterization and qualification of FDs
• Determination of critical positions
• Temperature data to evaluate the robustness of Lyo processes
Anton Mangold, Managing Director, Tempris
2.10 Stability of sugar-protein lyophilized formulations: Evaluation of
phase separation and mobility
• Basics of solid-state NMR spectroscopy as a technique for
evaluating phase separation and mobility in sugar-protein
formulations
• Impact of sugar crystallization, relaxation times, and phase
separation on protein stability will be discussed
• Comparison of micro-environmental protonation states using
solid-state NMR spectroscopy and visible probes will be shown
Eric Munson, Professor, Pharmaceutical Sciences,
2.50 Afternoon Tea
3.20 PANEL DISCUSSION: The impact of controlled nucleation
on product quality and the technology being used to
achieve controlled ice nucleation
• How nucleation technology controls the freezing stage of
the freeze drying process for more consistent and repeatable
outcomes that aid drug development and scale-up
• Traditional lyophilization practices vs controlled lyophilization
nucleation
• How to adhere to QbD manufacturing approaches and
optimize freeze drying cycles for biological formulations
Panelists:
Lokesh Kumar, Associate Scientist, Genentech
Andrea Weiland-Waibel, Managing Director,
Explicat Pharma GmbH
4.00 Chair’s Closing Remarks and Close of Day One
Lyophilization USA
Day One | Thursday 16th November 2017 www.lyophilization-usa.com
Sponsored by
Gore & Associates: Almost twenty years ago, Gore introduced what would be the first in the line of exciting
innovations for pharmaceutical and biopharmaceutical customers - the GORE® LYOGUARD® Freeze-Drying
Tray. Since then, we’ve developed many single- and multi-use products and process components - all
with the express focus on improving the customer experience by applying our materials technology and
engineering know-how to deliver step-change performance. www.gore.com/lyoguard
iQ-mobil is the developer and manufacturer of the wireless and battery-free temperature measurement system
Tempris. Tempris is used for real-time product temperature monitoring and controlling during lyophilization in
order to optimize processes and make pharmaceutical production more cost-efficient. Tempris is a PAT-tool
and available for all types of freeze dryers according to cGMP guidelines. www.tempris.com

Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING OPPORTUNITIES
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Teri Arri, SMi Marketing on +44 (0) 207 827 6162 or email: tarri@smi-online.co.uk
Supported by
Lyophilization USA
www.lyophilization-usa.com Day Two | Friday 17th November 2017
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
KEYNOTE ADDRESS
9.10 The development and scale up of a freeze drying cycle for
biotherapeutics
• Freezing, primary drying and secondary drying design space
• Scale up and effect of load configuration – secondary drying
focus
• Stability considerations and physical characterization on stability
• Container closure selection and characterization
Stuart Wang, Principal Scientist, Shire
9.50 Tech transfer & scale-up challenges and considerations for
• Common challenges faced when executing a tech transfer &
scale-up project
• Considerations for a successful tech transfer & scale-up project
• Integrating process, product & lyophilizer equipment
• Case studies
Adam Viverette, Associate Director Manufacturing,
Science & Technology, Melinta Therapeutics
11.00 Optimization of primary drying cycles using mathematical
modelling
• Influence of annealing on resistance and primary drying for IGG
molecules
• Assessing the variables depending on product properties
• Modelling Lyophilization processes to develop optimized cycles
and scale-up strategies
Melissa Lash, Scientist, Drug Product Development, Johnson And
Johnson
11.40 Lyocycle development and PAT based optimization
A case study including modern lyo cycle process performance
qualification leading to a PAT real time feedback system controlled
lyo cycle for continued process verification
• Analysis of critical quality attributes of a freeze-dried product
• Related critical process and product parameters – The product
temperature
• Lyo robustness testing to establish process boundaries and the
lyo cycle design space
• Modern lyo process validation and the implementation into
regulatory Lyophilization
12.20 Networking Lunch
1.30 Design of Experiment to optimize freeze drying process with
a small budget
• Introduction/Context of lyophilization optimization
• Screening design
• Augmented design
• Process optimization
2.10 CASE STUDY: Bulk lyophilization
• Excipients and equipment
• Building strategies and action plans for the development and
implementation of flexible manufacturing concepts for sterile
• Products across existing Amgen network sites
• Employing flexible concepts to manufacture variety of
• How to manage collaboration between cross functional
teams for successful technology transfer
Speaker to be confirmed
2.50 Afternoon Tea
3.20 PANEL DISCUSSION: Batch process vs
continuous process
• What are the challenges with continuous
freeze drying and how to overcome these
• Methodology to reduce the processing time of the
fundamental steps
• Areas in need of innovation with regards to lyophilization
Panelists:
Eric Munson, Professor, Pharmaceutical Sciences,
4.00 Chair’s Closing Remarks and Close of Day Two

Implementation of Quality by Design
principles into lyophilization processes
Overview of the workshop:
Short introduction into QbD in the context of Lyophilization
processes quality target product profile for freeze-dried
products. Critical quality attributes for freeze dried products-
what is relevant for the lyoprocess? The Critical Formulation
Temperature- how to determine the CFT – what is the
relevance of the Critical Formulation Temperature. The use of
PAT to monitor critical performance attributes of process and
product Lyocycle robustness testings
Reasons to attend this workshop:
• Learn about quality built into the process in the context of lyo
• Understand the interrelationship of formulation and process
• Learn how to determine the CFT
• What PAT techniques are available?
• Lyocycle robustness testings to evaluate the process
boundaries, how to transfer this into commercial scale
lyophilization
Programme
08.30 Registration and Coffee
09.00 Opening remarks and introductions
09.10 Session 1 - Short Introduction into QbD in the context
of Lyophilization processes
• What is QbD?
• QbD and the Lyoprocess
• Quality target product profile for freeze-dried
products
• Critical Quality attributes
09.50 Session 2 - The Critical Formulation Temperature
• How to determine the CFT
• The CFT determined by predominantly amorphous
or crystalline systems
• Tg’ and Te
• Controlled Nucleation/Annealing
11.00 Session 3 - PAT Tools available for Lyophilization
Processes
• MTM - batch method
• TDLAS
• Comparative pressure measurement
• Invasive Thermocouples and TEMPRIS
11.40 Session 4 - Lyocycle robustness testings to evaluate
the process boundaries and how to transfer this into
commercial scale lyophilization
• Lyo robustness testings and their regulatory
relevance
• Establish process boundaries
• Transfer in commercial scale
• How to include the work into the regulatory
submission
12.20 Closing remarks
12.30 Close of workshop
About the workshop leader:
Andrea Weiland, Ph.D., is Managing Director of
Explicat® Pharma GmbH, a privately owned
companyprovidingtechnicalprojectmanagement
services and pharmaceutical development
services to Pharmaceutical Industry (CMC). she
is a Pharmacist with a Ph.D in Pharmaceutical Technology
on biodegradable microspheres and cyclodextrins (Ludwig
Maximilians University Munich).
She held several leadership positions within Pfizer, working as
Project Manager in process technology and being responsible
for technology transfer & process development, mainly on
sustained release solid dosage forms. Within R&D she was
Responsible Scientist for pharmaceutical development
(Phase I - III, candidate characterization and lyophilization
projects. Andrea Weiland is Qualified Person and a member
of AAPS as well as several other professional institutions
based in Europe, e.g. APV, DphG, Bay. LAK, A3P.
About the organisation:
Explicat was founded by Dr Andrea Weiland, Birgit Hettinger
and Ulrich Waibel in 2005. Since then, Explicat supports
pharmaceutical companies, manufacturers, developers and
laboratories around the world. Explicat comprises the know-
how of pharmacists, engineers, chemists, biochemists and
economists with international experiences.
Workshop Leader:
Andrea Weiland-Waibel,
Managing Director, Explicat Pharma GmbH
HALF-DAY PRE-CONFERENCE WORKSHOP
Wednesday 15th November 2017
8.30 – 12.30
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

Introduction to Design of Experiments
Overview of the workshop:
This class is an introduction course to the concept of
Design of Experiments. First, attendees will learn, using
a simple example, the value of DoE and how it can
drastically increase the amount of information provided
by each experiment. Then, we’ll discuss how to choose
the appropriate design for different situations. Attendees
will have an overview of the DoE catalogue, including the
advantage of each type of design (Screening Designs,
Factorial designs, Response-surface designs, and optimal
designs). Finally, attendees will gain an appreciation for the
many ways output can be used to better understand and
optimize processes.
Reasons to attend this workshop:
• Introduction to what is so special about DoE
• Practical examples of how to plan an experiment
• Factorial designs
• Learn about response-surface designs
• Gain experience of optimal designs
Programme
13.30 Registration and Coffee
14.00 Opening remarks and introductions
14.10 Session 1 - Why DoE?
• What is DoE?
• What can be achieved
• A simple example
15.00 Session 2 - DoE Catalogue
• Screening designs
• Factorial designs
• Response-surface designs
• Optimal designs
16.00 Afternoon Tea
16.30 Session 3 - Now what?
• What happens after the experiment is done?
• Response surface optimization
• Optimization of several CQAs together
17.20 Closing remarks
17.30 Close of workshop
About the workshop leader:
Perceval Sondag, MSc Statistics is a Principal
Statistician at Arlenda, Inc. Perceval has
extensive experience in statistical methods
for assay development and validation,
having worked closely with scientists in a number of
biotech and pharmaceutical companies to improve
their manufacturing processes, including freeze drying
processes. He has authored multiple publications, including
a paper on Quality by Design
About the organisation:
Arlenda is recognized as a global leader in the application
of Bayesian methodology consulting and programming
to the Biopharma industry, from pre-clinical to late phase
studies and in a wide range of therapeutic areas. Beginning
in non-clinical studies and continuing through Phase 2, all
efforts are made to ensure the success of the Phase 3 study
and the eventual approval of the NDA.
Modeling the effect of the drug product on the body,
including the inherent uncertainty and predicting the
effects of changes in dosages, administration, or frequency
can have a profound effect on both the cost and duration
of a development program. Arlenda can help.
Workshop Leader:
Perceval Sondag,
Principal Statistician, Arlenda
HALF-DAY PRE-CONFERENCE WORKSHOP
Wednesday 15th November 2017
13.30 – 17.30
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA

LYOPHILIZATION USA
Conference: Thursday 16th & Friday 17th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Workshops: Wednesday 15th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
4 WAYS TO REGISTER
www.lyophilization-usa.com
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd,
Ground & First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Payment: If payment is not made at the time of booking, then an invoice will be issued and must
be paid immediately and prior to the start of the event. If payment has not been received then
credit card details will be requested and payment taken before entry to the event. Bookings within
7 days of event require payment on booking. Access to the Document Portal will not be given until
payment has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send
a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge,
providing that cancellation is made in writing and received at least 28 days prior to the start of the
event. Regretfully cancellation after this time cannot be accepted. We will however provide the
conferencesdocumentationviatheDocumentPortaltoanydelegatewhohaspaidbutisunable
to attend for any reason. Due to the interactive nature of the Brieﬁngs we are not normally able
to provide documentation in these circumstances. We cannot accept cancellations of orders
placed for Documentation or the Document Portal as these are reproduced speciﬁcally to order.
If we have to cancel the event for any reason, then we will make a full refund immediately, but
disclaim any further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection
Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about
other products and services. Unless you tick here □ we may also share your data with third parties
offeringcomplementaryproductsorservices.Ifyouhaveanyqueriesorwanttoupdateanyofthe
data that we hold then please contact our Database Manager databasemanager@smi-online.
co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your
address on the attached letter.
Payment must be made to SMi Group Ltd, and received before the event, by one of the
following methods quoting reference P-260 and the delegate’s name. Bookings made within
7 days of the event require payment on booking, methods of payment:
□ UK BACS Sort Code: 30-00-09, Account: 11775391
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account: 11775391
IBAN: GB75 LOYD 3000 0911 7753 91
□ Cheque We can only accept Sterling cheques drawn on a UK bank.
□ Credit Card □ Visa □ MasterCard □ American Express
All credit card payments will be subject to standard credit card charges.
Card No: □□□□ □□□□ □□□□ □□□□
Valid From □□/□□ Expiry Date □□/□□
CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
Cardholder’s Name:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
Card Billing Address (If different from above):
VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged
on Document portal and literature distribution for all UK customers and for those EU
Customers not supplying a registration number for their own country here.
______________________________________________________________________________________
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712
I cannot attend but would like to purchase access to the following
Document Portal/paper copy documentation Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
Unique Reference Number
Our Reference LVP-260
EARLY BIRD
DISCOUNT
□ Book by 30th June 2017 to receive $300 off the conference price
□ Book by 29th September 2017 to receive $100 off the conference price
DELEGATE DETAILS
Terms and Conditions of Booking
PAYMENT
VAT
DOCUMENTATION
VENUE Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
CONFERENCE PRICES
I would like to attend: (Please tick as appropriate) Fee
□ Conference & 2 Workshops $2897.00
□ Conference & 1 Workshop A □ B □ $2398.00
□ Conference only $1899.00
□ 2 Workshops $998.00
□ 1 Workshop only A □ B □ $499.00
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees $1598 + VAT $1917.60
The conference fee includes refreshments, lunch, conference papers, and access to
the Document Portal. Presentations that are available for download will be subject to
distribution rights by speakers. Please note that some presentations may not be available
for download. Access information for the document portal will be sent to the e-mail
address provided during registration. Details are sent within 24 hours post conference.

Lyophilization USA 2017

Recomendados

Recomendados

Más contenido relacionado

La actualidad más candente

La actualidad más candente (20)

Similar a Lyophilization USA 2017

Similar a Lyophilization USA 2017 (20)

Último

Último (18)

Lyophilization USA 2017