Logo of BIofidus AG

CE Analysis

Due to the unique production conditions during the biosynthesis of biological drugs as well as their complex nature, the final product may exhibit a variety of molecular deviations. These process- and product related impurities are not completely avoidable due to the large number of manufacturing steps and can be further increased by other influencing factors along the value chain. As the identification, control and reporting of impurities is required by regulatory agencies such as the FDA and EMA the qualitative and quantitative examination of impurities is therefore a fundamental pillar of quality assurance during the manufacturing process of biologics and biosimilars.

Our scientists at Biofidus AG know how to routinely and reliably distinguish between process- and product-related impurities and help you define appropriate acceptance criteria for your product development. According to the ICH Q6B guideline, we offer a broad range of bioanalytical packages for the purity analysis of your upstream and downstream processes in the production of peptides, antibodies, recombinant proteins and vaccines.

Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist

bioanalytical services

Tell us about your project

We‘ll advice you to define your assay needs

By sending the contact form you agree to our privacy policy.
*By submitting this form, you are consenting to receive emails from: Biofidus AG. You can revoke your consent at any time by using the unsubscribe link, found at the bottom of every email. Please see our privacy policy.

Technologies used

Please reach out to Our expert Dr. Anja Doebbe for all inquiries related to CE, CEX-MS, cIEF and CZE analysis.

Phone: +49(0)521 89 739 064
Mail: Anja.Doebbe@Biofidus.com

WordPress Cookie Hinweis von Real Cookie Banner