Conference on 3rd Annual Lyophilization (Workshop only)

Ensuring optimum formulations for pharmaceuticals and biologicals
To be held on 24th - 26 February,2010,Boston Harbor Hotel at Rowes Wharf, Boston, USA

Key Speakers

Larry Gatlin, Global Head, Technology Development & Production, Novartis
Nicholas Warne, Director, Formulations, Wyeth
David A. Hamilton, Manager, Pharmaceutical Technology, Global Technical Services, Merck & Co.
Venkat Koganti, Senior Scientist, Pfizer
Serguei Tchessalov, Principal Research Scientist, Wyeth Biotech
Alexander Klibanov, Novartis Endowed Chair Professor of Chemistry and Bioengineering, Massachusetts
Institute of Technology
Charlie Tang, Fellow Scientist, Regeneron Pharmaceuticals
Enric Jo Cardoso, Plant Manager, Reig Jofré Group
Christophe Wagner, Research & Development Director, SGD Group
Gerhard Schramm, Associate Director, Wilco
Walt Pebley, Director of Business Development, Oregon Freeze Dry
J. Jeff Schwegmann, Founder & Chief Executive Offi cer, AB Biotechnologies

Without lyophilization, nearly 60% of biopharmaceuticals including plasma, vaccines and antibodies could not be commercially available. With a greater trend to outsource manufacturing and more biologicals requiring freeze-drying, this $1.5bn market is set to maintain its year-on-year double digit growth.

Although the commonest way to ensure longevity and stability for complex molecules, lyophilization remains costly, complex and facility-intensive. Fine-tuning cycle parameters and trial-and-error experimentation, also means the procedure remains as much of an art as a science. As reducing development time becomes increasingly important in today’s economic climate, a rational, empirical approach to cycle design can save you time and money, especially when upscaling. More importantly, a robust lyophilization cycle will guarantee a safe and effective product.

Mastering these complex and inter-related requirements is no mean feat and Visiongain’s 3rd Annual Lyophilization conference provides distilled intelligence on formulation and process development for biopharmaceuticals. With a workshop and sessions led by experts, you will gain a thorough understanding to provide the best outcome for your business. Case studies from industry will offer strategic insights to help you optimize key input and output parameters, and troubleshoot challenges with temperature-sensitive molecules or solid proteins. In addition you will also gain the latest insights into:

• Rational approaches to pre-formulation and formulation process
• Designing product-specific freezing and sublimation and desorption protocols
• Improving analytical methodology to characterize frozen systems and freeze-dried solids
• Characterizing the final dried formulation
• Accurately predicting product stability at the intended storage temperature
• Ensuring cGMP, QbD, QC and QA
• Consistently achieving the desired product quality
• Improving process engineering dynamics and scale up
• Troubleshooting manufacturing problems
• PAT in manufacturing and the lab

Day 1

3rd Annual Lyophilization
Thursday 25th February 2010

09:00 Registration and refreshments
09:30 Opening address from the chair
Nick Warne,Director, Formulations,Wyeth

09:40 Lyophilization of biologicals

• Essential concepts
• Equipment required
• Sequence of operations

David A. Hamilton,Manager, Pharmaceutical Technology, Global Technical Services Merck & Co.

10:20 Main manufacturing challenges in lyophilization processes

• Main failures with lyophilized production: the real world
• Integration of quality challenges into cost challenges
• From basic product knowledge to product release

Enric Jo Cardoso,Plant manager,Reig Jofré Group

10:50 Morning refreshments
11:10 Lyophilization and its denaturation stresses

• Denaturation stresses during lyophilization
• Monitoring protein denaturation upon lyophilization
• Reversilibility of freezing or lyophilization-induced protein denaturation

Charlie Tang,Fellow Scientist,Regeneron Pharmaceuticals

11:50 Rational choice of excipients for use in lyophilized formulations

• Characterization of protein formulations prior to lyophilization
• Thermal treatment prior to drying and drying itself
• Optimizing residual moisture content

J. Jeff Schwegmann,Founder & Chief Executive Officer,AB BioTechnologies

12:30 Networking lunch

13:50 Instability, stabilization and formulation of solid protein pharmaceuticals

• Instability of solid proteins during storage
• Factors affecting stability of solid proteins
• Stabilization of solid proteins by excipients

14:30 Near infrared technology for residual moisture measurement in the cake, and laser absorption for oxygen measurement in the headspace. PAT on freeze dried vials

• New developments in automated inspection technology
• Technologies overview and discussion
• Real test data from a freeze drying environment

Gerhard Schramm,Associate Director,Wilco

14:50 Case study: preservation of form and functionality in the use of lyophilization

Walt Pebley,Director of Business Development,Oregon Freeze Dry

15:10 Meet the exhibitors and afternoon refreshments
15:30 Alternatives to freeze-drying

James Searles,Director of Process and Product Development,Aktiv-Dry

16:10 Panel discussion- complementary and alternative methods for drying biopharmaceuticals.

Topics will include foam drying, spray-drying, percolatiove vacuum-drying, inert spray-drying and spray freeze-drying.

16:50 Closing remarks from the chair
17:00 Networking drinks

Take your discussions further and build new relationships in a relaxed and informal setting..

Day 2

3rd Annual Lyophilization Friday 26th February 2010

09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 Case study: applying PAT tools to the lyophilization process

• Online measurement using Raman-NIR spectroscopy
• Implementation of new temperature sensors
• Use of PAT in formulation development

10:20 Pharmaceutical glass vials for freeze-dried drugs

• New drugs for new challenges
• Glass containers specially optimised for the freeze-drying process reduce glass breakage and improve heat transfer
• Design with regard to strength/stress and heat transfer Christophe Wagner

Research & Development Director,SGD Group

11:00 Morning refreshments
11:20 Structure and degradation of lyophilized proteins

• Reversible vs. irreversible protein denaturation upon lyophilization
• Deterioration of lyophilized proteins
• Structure of lyophilized proteins

Alexander Klibanov,Novartis Endowed Chair Professor of Chemistry and Bioengineering
Massachusetts Institute of Technology

12:00 Maintaining lyophilizer temperature uniformity and the importance of homogeneous freezing

• New developments in automated inspection technology
• Technologies overview and discussion
• Real test data from a freeze drying environment

12:40 Networking lunch
14:00 Presentation to be announced

Larry Gatlin,Global Head, Technology Development & Production,Novartis

14:40 Process capability in lyophilization

• Moisture mapping
• Vacuum leak rate
• Visual inspection defects

David A. Hamilton,Manager, Pharmaceutical Technology, Global Technical Services,Merck & Co.

15:20 Afternoon refreshments

15:40 Use of mathematical models to scale up lyophilization processes

• Systematic approaches using mathematical modeling
• Concordance between FEA theoretical models and
experimental results
• Additional estimates on water content present in the lyophile
and secondary drying calculations

Venkat Koganti,Senior Scientist,Pfizer

16:20 Lyophilization cycle scale-up: development to commercial manufacturing

Serguei Tchessalov,Principal Research Scientist,Wyeth Biotech

17:00 Chair’s closing remarks
17:10 End of conference

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