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Pharma Newsletters >> Eurofins BioPharma Services Newsletter 16 - March 2017 >> GMP biosimilar bioassay needs

Eurofins Lancaster Laboratories delivers one-stop-shop for GMP biosimilar bioassay needs

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Evelyn Kilareski, PhD, Principal Scientist, Eurofins Lancaster Laboratories,

Development and validation of cell-based biopotency assays can be a rate-limiting step when building a package of lot release and stability QC tests for a biosimilar. In addition, procurement and qualification of critical reagents, assay cell banks, and critical supplies can be costly, time consuming, and unpredictable. Eurofins Lancaster Laboratories has developed and validated cell-based potency assays for use in testing biosimilars such as filgrastim / pegfilgrastim, etanercept, adalimumab, rituximab, bevacizumab, and infliximab. These assays are ready-to-use to test in-process, drug substance, and drug product biosimilar molecules for their effect on cell proliferation, apoptosis, and/or ADCC activity.

In the world of bioassays, one size does not always fit all. In addition to providing ready-to-use assays for biosimilars, Eurofins Lancaster Laboratories has a team of Ph.D. level scientists dedicated to bioassay method development. This team uses their experience to rapidly redevelop any of the ready-to-use methods into productspecific bioassays that meet the unique requirements of individual clients. In addition to proliferation/apoptosis assays and ADCC assays, the Bioassay Team also has extensive experience in developing and validating a wide variety of bioassays, including reporter gene, intracellular signaling, receptor binding, and CDC assays, as well as ELISA-based potency assays.

Once a method has been developed and validated, Eurofins Lancaster Laboratories also has extensive experience in performing cGMP testing, as well as providing ongoing support in maintaining and troubleshooting bioassays. Reagents and cell banks used in ready-to-use assays are qualified and maintained by the team, which eliminates the need for clients to manage this aspect of working with a bioassay. This results in lower costs and a streamlined service experience for the client. This broad range of comprehensive experience and capabilities makes Eurofins Lancaster Laboratories the best one-stop-shop for biosimilar bioassay needs.

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