This benchmarking survey from the BioPhorum Forced Degradation team has conduced a benchmarking survey for formal comparability assessments.
Forced Degradation Studies
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The outcomes of several discussions on a survey conducted on forced degradation studies oxidation studies is available in this BioPhorum member only document.
A benchmarking survey looking at the Forced Degradation Study (FDS) correlation to long term degradation. It demonstrates the challenges in the area experienced by member companies.
Forced degradation studies for drug product (DP) (lyo change to liquid for late phase) to support comparability
A BioPhorum member only benchmarking survey looking at approaches on the use of forced degradation studies for drug product (lyo to liquid formulation swap).
Slide Deck – Forced degradation studies (FDS): An industry perspective on common practice in forced degradation studies of biopharmaceuticals
The slides that support the webinar presentation ‘An industry perspective on common practise in forced degradation studies of biopharmaceuticals’, presented on 15 June 2021.