Pre-Formulation and Formulation Development of a Sound Bio Pharmaceutical Formulation that is cGMP C (Biotech)
Venue: Online Event
|Event Date/Time: May 10, 2012||End Date/Time: May 10, 2012|
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, Tgâ€™ 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.
- 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.