VelaLabs, a provider of analytical services to the global biologicals industry, and Evercyte, a producer of standardized, relevant cell systems, announced on 3 September 2013 that they had entered into a collaboration to commercialize immortalized target cells for the characterization of biosimilars.
The partnership between the two Austrian firms is expected to provide product-tailored bioassays by combining VelaLab’s expertise in the characterization of biosimilars with Evercyte’s knowledge on how to immortalize relevant primary target cells.
The standardized product-relevant cell lines will reduce the use of laboratory animals, as well as meet the increased demand for analyzing the biological activity of biosimilars and biologicals, according to co-founder and CSO of Evercyte, Johannes Grillari. The collaboration therefore ‘aims to introduce Evercyte’s cell lines into the [good manufacturing practice] GMP environment and to establish novel, relevant cell lines, including innovative reporter cell lines, for specific biopharmaceuticals, again for use under GMP conditions.’
The companies have already established a vascular endothelial growth factor (VEGF)-responsive cell line (HUVEC – Human Umbilical Vein Endothelial Cells) for potency testing of bevacizumab biosimilars. The originator product Roche’s Avastin (bevacizumab) is a humanized monoclonal antibody indicated for the treatment of breast, colorectal, kidney, lung and ovarian cancer. Avastin will lose its patent protection in the US in 2019 and in the EU in 2022 .
1. GaBI Online – Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 10]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
Source: EMA, VelaLabs