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Lyophilization process design for a given formulation. Principles of process scale up and transfer, introduction to the design space
October 25, 2019
Lyophilization process design for a given formulation. Principles of process scale up and transfer, introduction to the design space

Workshop will provide insights in the development of lyo-friendly formulations and lyophilization process design using Excel based primary drying model. Attendees will be also introduced to the process of inputs generation for the primary drying model, while accounting for the differences in scale. Primary drying model and formulation design templates will be provided to the attendees with the demonstration of their functionality.

FEATURED SPEAKERS

Serguei Tchessalov

Serguei Tchessalov

Research Fellow, Pfizer Inc.

Serguei Tchessalov

Research Fellow, Pfizer Inc.
Serguei Tchessalov

Dr. Serguei Tchessalov is a Research Fellow at Pfizer Bio Therapeutics R&D (Andover, MA). He received his Ph.D. from Institute of Applied Biochemistry (Moscow) on development of novel methods for formulation and process control during lyophilization. He completed his Post Doctoral training with prof. Pikal (UCONN). For the past 30 years (both, in Russia and US) Dr.Tchessalov is working on formulation and lyophilization process development of bacterial and viral vaccines, proteins and different biological materials. His current research is focused on lyophilization process scale up and transfer as well as processing of parenteral dosage forms (filtration, filling, freezing/thawing and etc).

Workshop agenda

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13:30

Registration & Coffee

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14:00

Session 1

• Introduction to the primary drying model
• Measuring of vial heat transfer coefficients Kv
• Estimation of dry product resistance Rp
 

Serguei Tchessalov, Research Fellow, Pfizer Inc.

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15:00

Session 2

Serguei Tchessalov, Research Fellow, Pfizer Inc.

• Demonstration of primary drying model
• Introduction to the design space
• Elements of process and product robustness studies
 

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15:40

Tea Break

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16:10

Session 3

Serguei Tchessalov, Research Fellow, Pfizer Inc.

• Lyo formulation 101
• Demonstration of formulation design template
• Impact of formulation on cycle
 

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17:10

Session 4

Serguei Tchessalov, Research Fellow, Pfizer Inc.

• Differences between scales: impact on lyophilization process
• Examples of model applications for the process scale up and transfer, assessment of impact of deviations on the product quality
• Impact of process tolerances on cycle duration
 

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18:00

Closing Remarks and End of Workshop


Research Fellow
Pfizer Inc.

Sheraton Boston Hotel

39 Dalton Street
Boston 02199
USA

Sheraton Boston Hotel

Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
 

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