This webinar on lyophilization technology will provide you the understanding required to develop an optimized, cGMP compliant formulation that is specifically designed for lyophilization.
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.
Areas Covered in the Seminar:
- Pre-formulation assessment.
- Selecting acceptable formulation components.
- Buffers and buffer capacity.
- Antioxidants, stabilizers, surfactants, bulking agents, complexing agents, cosolvents.
- Crystalline vs. amorphous vs. mixed systems.
- Eutectic melting, glass transition, and collapse temperatures.
- Thermal characterization techniques.
- Filling and fill volume.
- Biomolecule stabilization theory.
- Excipient considerations.
- Infrared analysis of proteins.