By Evercyte GmbH
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Evercyte Joins VelaLabs to Produce GMP-Compliant Immortalised Cell Lines
Vienna, Austria: – Evercyte, a producer of standardised, relevant cell systems, has entered into a co-operation with VelaLabs, a provider of analytical services to the global biopharmaceutical industry, to produce GMP-compliant immortalised cells as tools for biosimilar characterisation.
The co-operation will combine Evercyte’s expertise in immortalising relevant primary target cells with VelaLabs’ established capability in characterising biosimilars. Within this partnership product-tailored bioassays will be developed and a VEGF-responsive cell line(HUVEC) for potency testing of bevacizumab (Avastin) biosimilars has already been established.
Evercyte is now expanding its product range to include innovative reporter cell lines for specific biopharmaceuticals, as well as immortalised and standardised cell lines for analysing biosimilars. All these products will now be produced to internationally recognised Good Manufacturing Practice (GMP) standards.
Dr. Johannes Grillari, co-founder and Chief Scientific Officer of Evercyte, commented: “The partnership means that we will now be able to provide our respected standardised cell systems for biosimilar characterisation within a GMP environment to the huge benefit of manufacturers of biopharmaceuticals and biosimilars. We hope our GMP-compliant immortalised cell lines will now become the go-to option for manufacturers who need standardised cell systems for analysis.”
“There’s an ever-increasing need for product-relevant cell lines that can be standardised,” said Dr Grillari. ”This demand is being fuelled by restrictions on the use of laboratory animal as well as the increased number of applications that derive from analysis of biological activity of biosimilars and biopharmaceuticals,”
“Therefore, our co-operation 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,” he added.
Dr. Andreas Nechansky, co-founder and COO of VelaLabs, said: “In terms of regulatory compliance, stable cell lines are much more reliable than primary cells. We are pleased to offer bioassays based on this distinct advantage to our customers in the global biopharmaceutical industry.”
“Making immortalised cell lines available for GMP testing will complement the broad analytical method portfolio we have developed to serve the needs of manufacturers worldwide.”
Evercyte GmbH is a spin-off company of the University of Natural Resources and Life Sciences, Vienna (BOKU-VIBT). It was founded to offer immortalised 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 commercialising relevant cell model systems from donors of different genetic backgrounds as “pharmacocellomicsTM” is also improving the predictability of substance efficiencies and side effects in the general population.
About Vela Laboratories
GMP-certified Vela Laboratories (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.
Tel: +43 699 1816 2222
Investor Relations & Communications, Vela
Tel: +43 650 784 4940
For more information about Evercyte joins VelaLabs to produce GMP-compliant immortalised cell lines, please contact Evercyte directly.