Stability Testing
Stability testing of protein therapeutics is important to assess product degradation over time and ensure that it remains efficacious throughout its proposed storage life as well as to determine the effects of inappropriate storage.
Avacta Analytical can provide accelerated and long term stability testing, alongside its formulation development services, using biophysical endpoints to assess the secondary, tertiary and quaternary structure of the molecule and aggregation state. This highly accurate form of analysis is complementary to other standard methods and actually assesses the structure and conformation of the molecule which can have relevance to both the activity and immunogenicity of a molecule.
The basic requirements for a stability study are described in the ICH guidelines Q1A (R2): Stability testing of new drug substances and products a Q5C: Quality of biotechnological products: Stability testing of biotechnological/biological products.