PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSWednesday 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 £400REGISTER BY 28TH FEBRUARY AND SAVE £200REGISTER 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 , Pfi zer and GSK discuss the key to

securing successful scale-up in lyophilisation

• Benefi t from an agenda tailored towards driving effi ciency 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, Pfi zer

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 benefi ts?

• 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 fi nal 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, Pfi zer

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 fi ll volume on lyophilisation process performance and product quality

• Investigation to determine maximum achievable fi ll volume of Lyophilised drug product

• Impact on process performance and/or product Quality Attributes

• Understand risks and limitations of increasing fi ll 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

specifi c to your industry. Should you wish to join the increasing number of companies benefi ting 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 effi cient 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-effi cient measurement solution, and considerably simplifi es 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 OPPORTUNITIESWant 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, Pfi zer

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, Pfi zer

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 verifi cation of the most suitable stoppers for a given drug product

• Use of fi rst-principles modelling tools to predict the moisture uptake of drug products in stability

Emanuele Tomba, Scientist, GSK

10.30 Morning Coffee

11.00 Benefi ts 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 suffi ciently 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 effi cient freeze drying cycle

Jean-René Authelin, Global Head of Pharmaceutical Engineering, Sanofi

16.40 Chairman’s Closing Remarks and Close of Day Two

Supported byOffi cial Publications Offi cial 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

Programme08.30 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 • Benefi ts 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 physical forms, the development of preclinical and early phase 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 visitwww.pharmaterials.co.uk

The National Institute for Biological Standards andControl (NIBSC) is a global leader in the characterisation,standardisation and control of biological medicines. NIBSC plays a major role in assuring the quality of biological medicines 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 visitwww.nibsc.org

Workshop Leaders: Jason Gray, Director of Material Sciences, Pharmaterials Ltd

and Paul Matejtschuk, Principal Scientist, NIBSC - MHRA

HALF-DAY POST-CONFERENCE WORKSHOPWednesday 10th May 2017

08.30 – 13.00Copthorne Tara Hotel, London, UK

HALF-DAY POST-CONFERENCE WORKSHOPWednesday 10th May 2017

13.30 – 17.30Copthorne 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

• Infl uence 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 qualifi cation (FAT, SAT, IQ, OQ, PQ) of pharmaceutical

freeze dryers.

Workshop Leader: Georg Frinke,

Process Engineer Parenteral Production, Bayer

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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 REGISTERwww.pharmafreezedrying.com

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