Eurofins DiscoverX recently launched their contract research organization (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 seamlessly and expeditiously run potency lot release programs for bioinnovator and biosimilar drugs. This 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. To obtain this CRO certification, Vela Labs has proven to successfully transfer multiple client-sponsored assay methods using the PathHunter platform, resulting in highly reproducible cell-based potency lot release assays for complex biologics.
This certification program plays a critical role, as biopharma product developers have to prove their drug products are safe and effective (potent). The development of the potency assay starts during the preclinical phase. The potency assay is optimized while the product moves through downstream development, and is typically fully validated by the time an IND is filed. Potency can be determined via a binding assay, however, regulators prefer the use of a functional assay that mimic conditions in living cells when the molecule allows for it. Functional potency assays are performed utilizing cell-based assays, such as the PathHunter assays 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,” said stated Sailaja Kuchibhatla, senior vice president and general manager, Eurofins DiscoverX. “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 CRO's as seamlessly as possible.”
For more information on Eurofins DiscoverX's CRO Certification program, visit here.