Designing a Stability Study for Biologics

Stability storage and testing

Stability is a particular problem for biopharmaceutical products because the physical and chemical stability of peptides and proteins are often very sensitive to storage and transportation conditions. The purpose of this webinar is to explain the typical approach for the design of a stability study for biologics. The webinar also covers the specific challenges of these product types as well as typical degradation mechanisms.

Topics covered include:

  • Overview of ICH Q5C – Stability testing of biotechnological/biological products
  • Specific stability challenges for biologics
  • Protein and peptide degradation pathways
  • Evaluating stability – typical tests
  • In-use stability
  • Stability after reconstitution