The clear potential for aggregates of subvisible particles (SVPs) to cause immunogenic responses in both animals and humans was affirmed at the biotech “CMC Strategy Forum” held in Washington, DC, in mid-January.
The CMC strategy forums, which are coordinated by CASSS and FDA and held semiannually in the US and once a year in Europe, are designed to bring industry and regulators together to drill down on specific quality topic areas deemed important in progressing biotech product regulation. The mid-January forum, held in conjunction with the annual CASSS/FDA Well Characterized Biotechnology Pharmaceutical (WCBP) conference, focused specifically on “the analysis and immunogenic potential of aggregates and particles.”
After focusing on detection and characterization issues in the morning, participants at the one-day forum spent the afternoon exploring the connection between aggregates and immunogenicity.
While pointing to the clear evidence of the aggregate/immunogenicity relationship, forum participants also recognized that not all aggregates trigger immune responses, and that the types and levels of aggregates that will produce an immune response vary depending on the particular therapeutic protein involved.
[Analysis of the dialogue around the current issues and challenges in assessing aggregate immunogenicity for therapeutic proteins and monoclonal antibodies at the CMC Strategy Forum is provided for subscribers here. Non-subscribers can purchase the full story for $95 by contacting Peter Blachly (Peter@ipq.org). For subscription information, click here.]