ComplianceOnline, Online Event
Why Should You Attend:
The Food and Drug Administration (FDA) is becoming more and more educated in the practice and science of lyophilization. As such, they are asking more questions about lyophilization during NDA or ANDA document reviews, site visits to companies producing lyophilized products, etc. It is now expected by the FDA, that companies developing new formulations and lyophilization cycles must be able to explain, scientifically, why they have chosen each excipient they have added to a formulation, why they are using as much as they have added, what are the critical temperatures of the products (glass transition temperature, Tg’ or eutectic melting temperature, Te), etc. Companies that cannot produce this type of information run the risk of being delayed in getting their products approved and on the market, which can have a dramatic impact on their profit margin.
The topics described in this session will cover all of the aspects of understanding the justification for freeze-drying, the thermal properties of the formulation (crystalline, amorphous, mixed), the analytical techniques employed to characterize these systems, and how all of this information is used to develop a stable, optimized, cGMP compliant product. At the end of the session, the attendee will be able to develop a well-defined process for taking an empirical approach to designing formulations and the lyophilization cycles used to dry them. By understanding and applying these principles, companies have a much greater chance of getting products approved by the regulatory agencies than those companies that employ the “trial and error” approach to formulation and lyophilization cycle design.
- Understanding the thermal properties of a formulation (crystalline, amorphous, mixed).
- Understanding the critical temperatures (Tg', Te, Tc) of a formulation.
- Understanding different excipients in formulations and how they affect the thermal properties.
- Understanding issues associated with large molecule (monoclonal antibodies, globular proteins, etc) formulation and freeze-drying.