Combining Vela’s long-standing expertise in the characterization of biosimilars with Evercyte’s know-how to immortalize relevant primary target cells, the partnership will provide product-tailored bioassays. A VEGF-responsive cell line (HUVEC) has already been established for potency testing of bevacizumab (Avastin) biosimilars.
“In terms of regulatory compliance, stable cell lines are much more reliable than primary cells. We are pleased to bring bioassays based on this distinct advantage to our customers in the global biopharmaceutical industry”, said Dr. Andreas Nechansky, co-founder and COO of VelaLabs. “Making immortalized cell lines available for GMP testing complements the broad analytical method portfolio we have developed to serve the needs of manufacturers of biopharmaceuticals and biosimilars worldwide”.
“The need of product relevant cell lines that can be standardized is ever increasing in view of restrictions on the use of laboratory animal as well as the increased demand for analyzing the biological activity of biosimilars and biopharmaceuticals”, said Dr. Johannes Grillari, co-founder and CSO of Evercyte. “Therefore, our cooperation aims to introduce Evercyte’s cell lines into the GMP environment and to establish novel, relevant cell lines, including innovative reporter cell lines, for specific biopharmaceuticals, again for use under GMP conditions”.
About Vela Labs
GMP certified VelaLabs provides a broad portfolio of analytical methods for the preclinical and clinical development including studies in support of regulatory submissions and product release of biopharmaceuticals and biosimilars, including monoclonal antibodies and growth factors. Good Manufacturing Practice (GMP) is the gold standard in quality for the life sciences industry and a GMP environment is mandatory for regulatory approval and batch release of (bio)pharmaceuticals and active ingredients. VelaLabs is headquartered in Vienna, Austria.
Evercyte offers immortalized cells that retain their primary-like human cell characteristics for pharmaceutical R&D. Recently Evercyte entered the market for induced pluripotent stem cells by establishing human urine as a fully non-invasive method to generate relevant cellular model systems. Systematically establishing and commercializing relevant cell model systems from donors of different genetic backgrounds as “pharmacocellomicsTM” will also improve the predictability of substance efficiencies and side effects in the general population. Evercyte is a spin-off company of the University of Natural Resources and Life Sciences Vienna (BOKU-VIBT), Austria.