A well-thought-out clinical evaluation of the immunogenicity of monoclonal antibodies is a critical component of the regulatory clearance pathway, and making predictions and generalizations short of this clinical analysis is dangerous, UK’s National Institute for Biological Standards and Control Biotherapeutics Group Head Robin Thorpe cautioned the attendees at a PDA MAb workshop in Basel, Switzerland in September.
The limitations in a MAb sponsor’s ability to make immunogenicity predictions during the product characterization phase of development and the need for carrying out a carefully crafted clinical assessment strategy was a key theme of Thorpe’s during his presentation and in the discussion that followed.
Thorpe’s talk amounted to a valedictory address capping a 30-year career at UK’s NIBSC, where he played a prominent role in advancing biotech regulatory standards and understanding. He retired from NIBSC at the end of October.
The PDA workshop at which Thorpe spoke was focused specifically on the “CMC and regulatory considerations for immunogenicity assessment” of monoclonals. The four sessions of the workshop addressed: ● new guidelines and regulatory considerations ● the relationship of quality attributes to immunogenicity ● analytical requirements and challenges, and ● the implications of immunogenicity on the development of biosimilars.
Preparing the ground for Thorpe at the opening regulatory session was a presentation by an expert on immunogencity assessments from Austria’s Agency for Health and Food Safety, (BASG/AGES) Biologics Preclinical Assessment Group Head Gunter Waxenecker. The Austrian official reviewed the current expectations and guidance from European regulators for the clinical assessment process, and the challenges for MAb assessments, in particular.