This benchmarking survey from the BioPhorum Forced Degradation team has conduced a benchmarking survey for formal comparability assessments.
Forced Degradation
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Forced degradation studies oxidation studies
Oct 2021 | Benchmarking, Development Group, Forced Degradation Studies
The outcomes of several discussions on a survey conducted on forced degradation studies oxidation studies is available in this BioPhorum member only document.
Forced degradation studies for drug product (DP) (lyo change to liquid for late phase) to support comparability
Oct 2021 | Benchmarking, Development Group, Forced Degradation Studies
A BioPhorum member only benchmarking survey looking at approaches on the use of forced degradation studies for drug product (lyo to liquid formulation swap).
Forced degradation studies (FDS): An industry perspective on forced degradation studies of biopharmaceuticals: survey, outcome and recommendations
Jan 2020 | Development Group
Forced degradation studies (FDSs) are often used in biotherapeutic development to assess criticality of quality attributes and in comparability studies to ensure product manufacturing process consistency. To gain an understanding of current industry approaches for FDS, the BioPhorum Development Group–Forced Degradation Point Share group conducted an intercompany collaboration exercise, which included a benchmarking survey and group discussions around FDS of monoclonal antibodies. 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 article discusses the results of this global benchmarking 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 chemistry and manufacturing control product life-cycle and biomolecule needs.