Comparability studies play a crucial role in the evaluation of process changes during the manufacturing of biopharmaceutical products. The purpose of comparability studies is to show that the pre- and post-change compounds are comparable in terms of quality, efficacy and safety. Furthermore, comparability studies are required to generate evidence that demonstrates sufficient similarity (not identity) of biosimilars and the originator products with respect to their critical quality attributes (CQAs).
Comparability studies embrace complex and comprehensive analytical pipelines to determine the physicochemical properties, biological activity, product- and process related impurities as well as the stability of pharmaceutical drugs to ensure no adverse impact on their quality, safety and efficacy. Our vast experience and deep knowledge in assessing the impact of heterogeneities allows us to predict if a product will meet consistently approved specifications.
Biofidus offers a holistic and state-of-the-art comparability assessment service according to the ICH Q5 E guideline, to accelerate the approval of your biosimilars or process changes and to minimize the risk of later stage setbacks.
In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance, 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.
Standalone and integral bioanalytical services
PROTEIN SEQUENCE ANALYSIS
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