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Biosimlar Assessment Service. 3d render of several similar antibodies

Biosimilar studies

Biosimilar studies. We know what to do.

Experience top-tier biosimilar assessment services with Biofidus. Our biosimilar assessments focus on generating evidence that showcases the significant similarity (not identity) between biosimilars and originator products, specifically concerning critical quality attributes (CQAs).

Our biosimilar studies feature intricate and comprehensive analytical pipelines. We delve into physicochemical properties, biological activity, product- and process-related impurities, and pharmaceutical drug stability to ensure no adverse impacts on quality, safety, and efficacy. Drawing on our extensive experience and profound knowledge of assessing heterogeneities, we can predict a product’s consistency in meeting approved specifications.

Biofidus offers a holistic and state-of-the-art biosimilar and comparability assessment service according to the ICH Q5E 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.

Our capabilities

Extensive experience with :

Biofidus_Biosimilar Experience

Tell us about your project

We‘ll advice you to define your assay needs

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Technologies used

Our CEO Dr. Benjamin Müller advices you on all inquiries concerning our comparability assessments.

Phone: +49(0)521 89 739 060
Mail: Benjamin.Mueller@Biofidus.com

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