The Protein Aggregation and Biological Consequences focus group (PABC FG) was formed to study protein aggregation and immunogenicity. Ideally and globally, we are striving for an understanding of the qualitative and quantitative aspects of aggregation of therapeutic protein products to discuss and develop techniques to study aggregation and factors that cause aggregation and to discuss the potential impact of aggregation including immunogenicity and, for example kinetics, (bio)activity. The membership of this group will contain experts in formulation, analytics, regulatory, and clinical and preclinical safety and immunology.
- Establish a core group of interested investigators.
- Define the questions that need to be answered to understand protein aggregation (techniques, factors causing aggregation).
- Define the questions that need to be answered to understand the potential impact of protein aggregation on immunogenicity and e.g. pharmacokinetics, activity, etc.
- Promote research and cross-functional collaborations in this area.
- Promote discussions and education.
Section affiliations: BIOTEC | CPTR | RS