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Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.
On Feb. 24, 2020, Eurofins DiscoverX, the products company of Eurofins Discovery, announced that it has partnered with Vienna, Austria-based VelaLabs, a good manufacturing practices (GMP)-certified and good clinical laboratory practices (GCLP)-compliant contract laboratory. Under the deal, Eurofins DiscoverX will grant VelaLabs the status of a bioassay certified contract research organization (CRO), making it an official certified provider of PathHunter assay services.
VelaLabs was able to obtain the CRO certification by proving that it can successfully transfer multiple client-sponsored assay methods using the PathHunter platform, which resulted in highly reproducible cell-based potency lot release assays for complex biologics.
Eurofins DiscoverX recently launched their CRO certification program to support the needs of biotech and pharma companies to partner with CROs and contract development and manufacturing organizations (CDMOs) that can run potency lot release programs for bioinnovator and biosimilar drugs. The certification provides biopharma developers a transparent platform to access experienced CROs, while at the same time broadening and connecting the network of key stakeholders involved in successful drug development.
The certification program is intended to play a critical role in biologic drug development because biopharma product developers have to prove the safety and efficacy of their drug products. Potency assays are developed during the preclinical phase and are optimized while the product moves through downstream development. The assays are typically fully validated by the time an investigational new drug application is filed. While potency can be determined via a binding assay, regulators prefer the use of a functional assay that mimics conditions in living cells when the molecule allows for it. Functional potency assays are performed using cell-based assays, such as the PathHunter assays, which were developed and produced by Eurofins DiscoverX.
“PathHunter bioassays are being adopted by top global pharma and biotech companies as mechanism of action (MOA)-reflective functional assays for potency lot release studies. The simplicity of the platform, coupled with a broad menu, makes it attractive for our clients to drive their drug molecules for filings by using the assays. We are delighted to work with VelaLabs, a leading clinical CRO, and excited that they are the first CRO to gain this certification. This certification should provide a more seamless transfer of assays. We will continue with our mission to provide easy to implement, simple qualified MOA-reflective assays that enable transfer to CROs as seamlessly as possible,” stated Sailaja Kuchibhatla, senior vice-president and general manager of Eurofins DiscoverX, in a company press release.
“It is a pleasure for us to bring our previous expertise with the PathHunter platform into a long term collaboration with Eurofins DiscoverX,” said Markus Roucka, managing director of VelaLabs, in the press release.
Source: Eurofins DiscoverX