Understanding Phase Separation in Amorphous Lyophilized Protein Systems

Phase separation in amorphous lyophilized systems is often speculated to be a source of physical instability, however, limited detection methods have slowed the investigation of this phenomenon. As a result, systematic studies evaluating the impact of formulation and process parameters are sparse and the real impact of amorphous phase separation is still largely unknown. This webinar will review the present methodologies used to detect multiple amorphous phases in lyophilized protein systems. Additionally, the current understanding of the impact of both process parameters and formulation components on phase separation will be discussed. Presented by Adora Padilla, PhD Head of Drug Product Development, Technical R&D, GSK Vaccines US & Kelly Forney-Stevens, PhD Expert Scientist at GlaxoSmithKline Vaccines