Biosimilar Testing

Releasing a biosimilar product to market is extremely challenging. On the one hand, only a very well-equipped laboratory has the cappabilities to conduct this activity, ensuring purity, identity, and potency. On the other hand, the testing site should be GMP certified and have manufacturing authorization, subject to periodic inspections by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Quality Control for Release

KYMOS has acquired a wide experience as a testing lab for biosimilar products in GMP. We have different laboratories to afford the variety of analytical methods necessary for a comprehensive testing of a biosimilar product: biopharma testing, immunology, physical-chemical analysis and microbiology. The most common parameters included in a Certificate of Analysis of a biosimilar drug product for release are the following ones:

  • Chemical analysis: Isoelectric focusing, ion-exchange cromatography, SEC--HPLC HPLC, SDS-PAGE, capilar electrophoresis, UV-Vis.
  • Physical analysis: apperance, pH, osmolarity and particle matter
  • Microbiology: endotoxins and sterility

  • Biological activity: specific cell assay.

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Pre-developed assays

Despite each proprietary method has to be qualified or validated for each specific biosimilar, in KYMOS we have worked in different marketed biosimilars acquiring an important experience that allows us to speed up the analytical method transfer. Specifically:

  • Ranibizumab
  • Trastuzumab
  • Infliximab
  • Omalizumab
  • Filgastrim and PEG-Filgastrim
  • Insulin
  • Interferon
  • Coagulation factors

KYMOS is a reliable laboratory based in Barcelona, GMP and GLP certified, EMA and FDA inspected, that offers batch testing and batch release for biosimilar products. We have many references of important multinational companies in this field. Do not hesitate to contact us in case you are interested in our services.

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