Forced Degradation Studies
Forced degradation studies of biologics are a set of experiments designed to evaluate the stability of the active pharmaceutical ingredient (API) and drug product under extreme conditions. These studies involve exposing the biologic to a range of physical, chemical, and environmental stress conditions such as temperature, pH, oxidative stress, and photolytic degradation, to mimic an accelerated, environmental stability of the drug.
The studies embrace complex and comprehensive analytical pipelines to identify and characterize occurring degradation products (impurities) that may arise during the product’s lifecycle and how they affect the quality, safety, and efficacy of the drug. The results of these studies will improve the design and selection of appropriate production, formulation, packaging, and storage conditions to ensure the stability and quality of your drug product.
Our vast experience and deep knowledge in assessing the impact of degradants allows us to predict if your product will meet consistently approved acceptance criteria for product stability. Biofidus offers a holistic and state-of-the-art forced degradation assessment service according to the ICH Q1 guidelines, to accelerate the approval of your biologic or biosimilar. In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance (DS), its individual formulation matrix and your distinct analytical question.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.
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