Biotech 2012 - Pre-Formulation and Formulation Development of a Sound Bio Pharmaceutical Formulation that is cGMP Compliant

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.

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.