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Design and interpretation of accelerated stability studies of biologics

Presented at: Cambridge Healthtech Institute’s Bioprocessing Summit; 2012 Aug 20-23, Boston, MA.

Accelerated stability encompasses more than just the examination of higher temperature conditions during standard stability studies. A key aspect of accelerated stability is forced degradation studies in which the drug substance or drug product is exposed to extreme conditions to elucidate the types of degradation the molecule may undergo. These studies are conducted to provide materials during analytical method development in order to determine if a method is stability-indicating. Other uses of forced degradation studies include the evaluation of formulations and demonstration of comparability after process changes both before and after licensing. The regulatory guidance for accelerated studies is less prescriptive for biopharmaceuticals than for traditional small molecule drugs; the implications of these differences are discussed.