PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 10th May 2017, Copthorne Tara Hotel, London, UK
Getting the most out of DOE approaches
during freeze drying development
08.30 – 13.00
Workshop Leaders: Jason Gray, Director of Material Sciences, Pharmaterials Ltd
and Paul Matejtschuk, Principal Scientist, NIBSC - MHRA
Strategies to achieving process
transfer in lyophilisation
13.30 – 17.30
Workshop Leader: Georg Frinke,
Process Engineer Parenteral Production, Bayer
www.pharmafreezedrying.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
REGISTER BY 31ST JANUARY AND SAVE £400
REGISTER BY 28TH FEBRUARY AND SAVE £200
REGISTER BY 31ST MARCH AND SAVE £100
@SMIPHARM
Bridging the gap between small scale and large scale freeze drying production
SMi presents the 5th annual Conference on...
Copthorne Tara Hotel, London, UK
CONFERENCE: 8TH - 9TH
WORKSHOPS: 10TH
MAY 2017
Pharmaceutical
Freeze Drying
Technology
REASONS TO ATTEND:
• Sanofi, Pfizer and GSK discuss the key to
securing successful scale-up in lyophilisation
• Benefit from an agenda tailored towards
driving efficiency and commercial
competitiveness through reducing your
manufacturing costs and shortening
cycle time
• Stay at the cusp of emerging developments with
content delivered Novo Nordisk, and Roche
• Gain an overview of the latest innovations in
freeze drying technology, protein stabilization
and aseptic spray drying
• Escape regulatory risk through informed
guidance on QbD submissions
• Exciting insight into current and future
developments in continuous manufacturing
and upscaling
Sponsored by
KEYNOTE SPEAKERS INCLUDE:
• Jean-René Authelin, Global Head of Pharmaceutical Engineering,
Sanofi
• Pierre Goldbach, Pharmaceutical Development and Supplies, Roche
• Paul Matejtschuk, Principle Scientist, NIBSC - MHRA
• Mahammad Ahmed, Associate Scientist II, Medimmune
• Patrick Garidel, Head of Pharmaceutical Basic Development,
Boehringer Ingelheim
• Christoph Korpus, Laboratory Head, Merck
• Xiaodong Chen, Senior Research Investigator,
Bristol-Myers Squibb
• Georg Frinke, Process Engineer Parenteral Production, Bayer
CHAIRS FOR 2017:
Sune Klint Andersen,
Principal Scientist, Novo
Nordisk
Bakul Bhatnagar, Senior
Principal Scientist Bio
Therapeutics R&D, Pfizer

Pharmaceutical Freeze Drying Technology
Day One | Monday 8th May 2017
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Sune Klint Andersen, Principal Scientist, Novo Nordisk
OPENING ADDRESS
09.10 Freeze drying of biologics: The essentials
• Short introduction to the freeze-drying process and
freeze-dried market products
• Biologics in the dry state: What to consider?
• An overview of the formulation principles for freeze-dried
products
• Process development of freeze-dried products
• Primary packaging for freeze-dried products
• Analytics for the characterisation of lyophilisates
• What are the stability issues and how can these be
tackled
Patrick Garidel, Associate Director Protein Science,
Boehringer Ingelheim
09.50 Spray drying as an alternative to freeze drying and how to
combat the challenges
• Examples of how spray drying is currently being used in
industry – what are the benefits?
• How does spray drying compare to lyophilisation
currently?
• Application of drying techniques in continuous
manufacturing
Sune Klint Andersen, Principal Scientist, Novo Nordisk
10.30 Morning Coffee
11.00 Determining and controlling moisture content in
lyophilised products
• Importance of moisture to product appearance and
activity
• Freeze drying cycle and its impact on final moisture
content
• Techniques for moisture determination
• Relationship between moisture and activity
Paul Matejtschuk, Principle Scientist, NIBSC - MHRA
11.40 Challenges in freeze drying high concentration
biological formulations
• Formulation approaches for high concentration freeze
dried biologics
• Impact of freeze drying cycle on cake appearance and
protein stability
• Approaches for reducing viscosity and optimizing
reconstitution time
Pierre Goldbach, Pharmaceutical Development and
Supplies, Roche
12.20 Networking Lunch
13.30 The development and scale up of a freeze drying cycle for
bioproducts
• Lyophiliser modelling - Kv and sublimation
• Product characteristics – physical characterisation and
cake resistance
• Freezing, primary drying and secondary drying design,
deign space of primary drying
• Scale Up and effect of load confi guration – primary
drying focus
• Stability considerations and physical characterisation on
stability
• Container closure selection and characterisation
Tim McCoy, Managing Principal Scientist, Genzyme
14.10 Utilisation of modelling for process development, scale-up,
and tech transfer of lyophilised products
• Traditional approaches for process design, scale-up, and
tech transfer
• Rationale for need of modelling based approaches
• Description of the model and inputs into the model
• Case studies
Bakul Bhatnagar, Senior Principal Scientist Bio Therapeutics
R&D, Pfizer
14.50 Practical approaches to tech transfer in commercial
lyophilisation
• Designing a tech transfer programme for lyophilisation
cycles – strategy in increasing productivity
• Enhancing the performance of drying
• The use of mathematical models for scale-up/transfer of
lyophilisation cycles
Massimo Rastelli, Platform Lead Biopharm & Steriles centre
of Excellence Platform, GSK
15.30 Afternoon Tea
16.00 Leveraging model based approach to design and
optimising lyophilisation processes at different Stages
• Leverage Design of Experiments (DOE) to develop
statistical models for both formulation and process
parameters at early stage
• Integrated modelling and experimental approach to
enable robustness at mid stage
• Process optimisation to enable effi ciency by estimating/
measuring commercial equipment capabilities at late stage
• Case studies
Xiaodong Chen, Senior Research Investigator,
Bristol-Myers Squibb
16.40 Effect of fill volume on lyophilisation process performance
and product quality
• Investigation to determine maximum achievable fill
volume of Lyophilised drug product
• Impact on process performance and/or product Quality
Attributes
• Understand risks and limitations of increasing fill volume in
a vial
Mahammad Ahmed, Associate Scientist II, Medimmune
17.20 Chairman’s Closing Remarks and Close of Day One
ADVANCEMENTS IN TECHNOLOGY AND ITS EFFECT ON INDUSTRY
www.pharmafreezedrying.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
Sponsored by
STRATEGIES IN SECURING SCALE UP AND CONTINUOUS
MANUFACTURING
BUCHI For 75 years, BUCHI has been a leading solution provider in laboratory technology for R&D, quality control and production
worldwide. We serve a wide range of industries such as pharmaceuticals, chemicals, food & beverage, feed, environmental
analysis and academia. www.buchi.com/gb-en
Testo Quality, safety and efficient processes are crucial in the health and pharmaceutical sectors. Whether you work in clinics,
laboratories, cleanrooms, storage or transport, testo have the solution. We provide the right measurement instrument for every
application and provide instrument service and calibration on both testo and non-testo branded instruments, from our UKAS (ISO/
IEC 17025:2005) laboratory based in Alton, Hampshire. Testo Saveris 2 Wireless Temperature and Humidity Monitoring System offers
a simple cost and time-efficient measurement solution, and considerably simplifies the automated monitoring of climatic ambient
conditions. Values are transmitted by WiFi to the cloud, in the case of a limit value violation, the system automatically sends an
alarm by e-mail and/or SMS. No software is needed for recording, analysing and saving measurement data.
www.testo.co.uk or www.testo.com/en-UK/Pharmacy+and+Health/applications_pharma

Pharmaceutical Freeze Drying Technology
Day Two | Tuesday 9th May 2017
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
IMPLEMENTATION OF QBD AND PAT TOOLS WITHIN INDUSTRY
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Bakul Bhatnagar, Senior Principal Scientist Bio Therapeutics
R&D, Pfizer
OPENING ADDRESS
09.10 Considerations for reconstitution of freeze dried
pharmaceuticals
• Understand the contributions of cake disintegration,
wetting, hydration, and structure in the reconstitution of
freeze-dried proteins
• Investigate the effect of formulation and processing
variables on dissolution of the lyophilised proteins
• Identify differences in practices utilised to perform
reconstitution within product development vs. pharmacy
practice sites and provide recommendations for best
practices
Bakul Bhatnagar, Senior Principal Scientist Bio Therapeutics
R&D, Pfizer
09.50 Primary packaging for freeze- dried pharmaceuticals and
its importance to product stability
• Understanding the impact of stoppers for the shelf life
and stability of a freeze-dried drug product
• The importance of the stopper matrix and their link with
stopper processability and barrier properties
• Approaches for the selection and verification of the
most suitable stoppers for a given drug product
• Use of first-principles modelling tools to predict the
moisture uptake of drug products in stability
Emanuele Tomba, Scientist, GSK
10.30 Morning Coffee
11.00 Benefits and Challenges of using PAT as part of a QbD
Approach to Freeze-Drying
Key points:
• PAT methodologies in freeze-drying and the need for
careful data interpretation
• Challenges of applying various PAT methods at different
scales
• Impact of data on the size and shape of the Design
Space in QbD
Kevin Ward, Director of Research and Development,
Biopharma Group
11.40 Secondary Drying of FD Products and Cake Collapse
• Understanding that most freeze dried cakes are
hygroscopic amorphous glasses
• At a sufficiently high absorbed moisture content the cake
will pass through its Tg and collapse
• Moisture induced collapse of freeze dried sucrose,
trehalose and other commercial FD products have been
studied at 10, 25 and 40C
• The FD collapse events have been visualised using
automated Dynamic Vapour Sorption instrumentation
• The temperatures and humidity’s for cake collapse
are reported and recommendation for most stable
formulations with respect to cake collapse are provided
Daryl Williams, Director of Development, Discovery Space
and Reader in Particle Science Department of Chemical
Engineering Imperial College London
12.20 Networking Lunch
13.30 Detection of Silicone oil Leaks in Lyo-Installation with
standard Equipment
• The impact of silicone oil leaks on machinery
• Break – down of the tools currently being used to detect
silicone oil leaks: what the advantages and pitfalls?
• Are mass spectrometers always essential - tips on how to
get the most out of standard equipment
Georg Frinke, Process Engineer Parenteral Production,
Bayer
14.10 Small Molecules Too!
• The use of Lyophilisation for solubility enhancement
• Stabilisation of amorphous forms
• Comparison with Spray Drying
• Case studies
Jason Gray, Director of Material Sciences, Pharmaterials Ltd
14.50 Afternoon Tea
15.20 Lyophilisation in Dual Chamber Cartridges – from Energy
Transfer to Process Control
• Process challenges during freeze-drying in DCCs
• Selection of adequate holder devices
• Process design and control with the “DCC-LyoMate
procedure”
Christoph Korpus, Laboratory Head, Merck
16.00 Optimisation of industrial freeze drying cycle - two real life
examples
• Two examples of “old” products
• How product physical characteristics (Tg’, eutectic
melting, crystallization kinetics), process mathematical
modelling and the equipment intrinsic limitations are
taken into account)
• How this assists in designing a safe and economically
efficient freeze drying cycle
Jean-René Authelin, Global Head of Pharmaceutical
Engineering, Sanofi
16.40 Chairman’s Closing Remarks and Close of Day Two
Supported byOfficial Publications Official Media Partners
COMBATING ISSUES IN THE LYOPHILISATION PROCESS

Getting the most out of DOE approaches
during freeze drying development
Overview of the workshop:
This workshop is designed to focus on the development and
scale up of freeze drying processes covering the basics of
freeze drying, the decision process in formulation /cycle
development, the key aspects to look out for and suggestions
on different QbD/DOE approaches. Throughout the workshop
case studies will be used to demonstrate both success stories
and also the effects of an inappropriate design.
Reasons to attend:
• Learn the fundamentals of lyophilisation development
• Understand the different approaches available
• Gain practical advice to get the best out of your
development
• A chance to discuss your development issues
Programme
08.30 Registration and coffee
09.00 Opening remarks and introductions
09.10 Session 1 Approaches to Lyophisation Development
• Understanding the process
• QbD and its role in lyophilisation cycle
development
• Alternative approaches
09.50 Session 2 Classical Approaches
• What is required
• What information can be gained
• Experimental analysis and what to look for.
10.30 Coffee Break
11.00 Session 3 Applications of DOE in Formulation
Development
• Study Design
• Constraints
• Benefits of DOE
11.40 Session 4 The Good, The Bad and the Ugly
• Practical considerations for DOE
• Getting the analysis right
• Examples
12.20 Closing remarks
13.00 Close of workshop
About the Workshop Leaders:
Jason has over 20 years of experience within
academia and the pharmaceutical industry, After
several years as a Postdoctoral Research Associate at
UMIST Jason joined Zeneca as a formulation scientist.
In 2002 he joined the Merck Generics group as Head of their
Physical Properties Laboratories then Kuecept as their Head of
Operations in 2008.
In 2010 he was recruited by Bradford University to help establish
their Biopharmaceutical Formulation In 2016 Jason joined
Pharmaterials Ltd. to establish a new Material Sciences Group.
Paul Matejtschuk leads the Standardization Science
Section at the National Institute for Biological
Standards & Control NIBSC’s focus is on the quality
of biological medicines. His team is focused on
delivering formulation and lyophilization conditions for a wide
range of biological reference materials and research interests.
Paul has over 25 years postdoctoral experience, covering
downstream processing, characterization and analysis of
biological materials, he is also Director of the International
Society for Lyophilisation
About the organisation:
Pharmaterials Ltd is a science driven contract research
organisation specialising in the optimisation of drug substance
physicalforms,thedevelopmentofpreclinicalandearlyphase
formulations and the manufacture of clinical trial materials.
We are particularly experienced in the development of
poorly soluble drug substances and have taken a great many
such formulations to the clinic.For further details please visit
www.pharmaterials.co.uk
The National Institute for Biological Standards and
Control (NIBSC) is a global leader in the characterisation,
standardisation and control of biological medicines. NIBSC
playsamajorroleinassuringthequalityofbiologicalmedicines
worldwide through the provision of biological reference
materials, by testing products and carrying out research.
Our expert scientists also provide advice on a routine basis
and in response to emergencies. Further details please visit
www.nibsc.org
Workshop Leaders: Jason Gray, Director of Material
Sciences, Pharmaterials Ltd
and Paul Matejtschuk, Principal Scientist, NIBSC - MHRA
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 10th May 2017
08.30 – 13.00
Copthorne Tara Hotel, London, UK

HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 10th May 2017
13.30 – 17.30
Copthorne Tara Hotel, London, UK
Strategies to achieving process
transfer in lyophilisation
Overview of the workshop:
Upon completion of this course participants will know the
basic principles of Transfer aspects:
• The Workshop will provide a better understanding of the
process and required design parameters.
• The current practice of process transfer will be discussed
• An outlook into the future about recently developed sensor
and process control technologies will be discussed.
Reasons to attend:
• Lyophilisation Process and linked quality Parameters
• Influence of the Lyophiliser and resulting risks
• Better Understanding of the transfer process
• Better preparation for a future transfer
• Reasons to think about other Lyophilisation processes
Programme
13.30 Registration
14.00 Opening remarks and introductions
14.10 Session 1 - Process Basics
• Thermodynamics of Freeze Drying /Freezing /
Sublimation / Desorption
• Key Parameters for Lyo Processes
• What makes a good cake?
14.50 Session 2 - Transfer Principles
• Process relation with the technical installation
• Measures to keep the process constant
• Process tolerances / Process Robustness
15.30 Afternoon Tea
16.00 Session 3 - Current Transfer – classical approach
• Classical transfer
• Robustness Studies
16.40 Session 4 - Prospects of future challenges
• Introduction into future systems
• Available Technologies
• Risks of Opportunites to install future Technology
• 100% Control
17.20 Closing remarks
17.30 End of workshop
About the Workshop Leader:
Georg holds a degree in Engineering from UAS,
Cologne, Germany. He is Site & Process Engineer
at Bayer Pharma and responsible for the technical
operation of the parenteral facility. Previously, he worked as
Process Engineer for the parenteral facility of Jansen Cilag in
Schaffhausen, Optima (Klee) and GEA Lyophil / Steris. Among
others he is specialized in the development of customized
Freeze-Drying processes (particularly upscaling with PAT) and
in the qualification (FAT, SAT, IQ, OQ, PQ) of pharmaceutical
freeze dryers.
Workshop Leader:
Georg Frinke,
Process Engineer Parenteral Production,
Bayer

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-212 and the delegate’s name. Bookings made within
7 days of the event require payment on booking, methods of payment:
□ UK BACS Sort Code 300009, Account 00936418
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account 00936418
IBAN GB48 LOYD 3000 0900 9364 18
□ 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
EARLY BIRD
DISCOUNT
□ 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-212
DELEGATE DETAILS
Terms and Conditions of Booking
PAYMENT
VAT
CONFERENCE PRICES
DOCUMENTATION
VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SY London
PHARMACEUTICAL FREEZE DRYING TECHNOLOGY
Conference: Monday 8th & Tuesday 9th May 2017, Copthorne Tara Hotel, London, UK Workshops: Wednesday 10th May 2017, London, UK
4 WAYS TO REGISTER
www.pharmafreezedrying.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
□ Book by 31st January to receive £400 off the conference price
□ Book by 28th February to receive £200 off the conference price
□ Book by 31st March to receive £100 off the conference price
I would like to attend: (Please tick as appropriate) Fee Total
□ Conference & 2 Workshops £2697.00 + VAT £3236.40
□ Conference & 1 Workshop A □ B □ £2098.00 + VAT £2517.60
□ Conference only £1499.00 + VAT £1798.80
□ 2 Workshops £1198.00 + VAT £1437.60
□ 1 Workshop only A □ B □ £599.00 + VAT £718.80
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees £999.00 + VAT £1198.80
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.