An Industry Perspective on Forced Degradation Studies of Biopharmaceuticals: Survey Outcome and Recommendations

Abstract The BioPhorum Development Group (BPDG) is an industry-wide consortium enabling networking and sharing of common practices for the development of biopharmaceuticals. Forced degradation studies (FDS) are often used in biotherapeutic development to assess criticality of quality attributes (CQAs) and in comparability studies to ensure product manufacturing process consistency. To gain an understanding of current industry approaches for forced degradation (FD) studies, the BPDG-Forced Degradation Point Share (BPDG-FDPS) group conducted an inter-company collaboration exercise, which included a bench-marking survey and group discussions around forced degradation studies of monoclonal antibodies (mAbs). The results of this industry collaboration provide insights into the practicalities of these characterization studies and how they are being used to support the product lifecycle from innovation to marketed products. The survey requested feedback on the intended purpose, materials, conditions, number and length of time points used and analytical techniques carried out to give a complete picture of the range of common industry practices. This paper discusses the results of this global bench marking survey across 12 companies and presents these as a guide to a common approach to FDS across the industry which can be used to guide the design of FDS based on CMC product life-cycle and biomolecule needs.