CDMO/CRO Certification Program for Cell-based Assays

Take Your Cell-based Services to the Next Level: From Assay Qualification to Method Transfer

Biopharmaceutical companies developing and manufacturing biologics, biosimilars, and generics need vital resources and efficiencies from Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) that can support their therapeutic programs with robust bioassays. Certified CDMO/CROs are recommended to biopharma clients aligned with their focused downstream therapeutic efforts.

The CDMO/CRO Certification Program from Eurofins DiscoverX® trains, validates, and qualifies trusted CRO/CDMOs to properly and efficiently run Eurofins DiscoverX bioassays supported by seamless method transfer capabilities supported by a global team of Application Scientists.

At Eurofins DiscoverX, you can find the most extensive portfolio of qualified bioassays and custom bioassay development services. With over two decades of experience, biopharma clients seek our advice when moving their drug product downstream and need a CRO/CDMO that can successfully run our bioassays and support the potency lot-release testing of their therapeutic candidates.

Begin your Certication

Product Highlights
  • Full Support – Supporting CRO/CDMOs every step of the way – from assay qualification to method transfer
  • Industry Leader – Implementing the highest quality bioassays in the industry
  • Certification Program – Qualifying CRO/CDMOs to run Eurofins DiscoverX bioassays to help CRO/CDMO clients therapeutic efforts ultimately
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Testimonials

Vela Laboratories

“The simplicity of Eurofins DiscoverX assay platform, coupled with a broad menu, makes it attractive for our clients to use them in potency, immunogenicity, and stability testing programs. We at VelaLabs, headquartered in Vienna, are a GMP-certified and GCLP-compliant contract laboratory that offers in-depth analytical characterization services for pharmaceuticals including biosimilars, hormones, monoclonal antibodies and peptides. It is apparent to us that the ready-to-use, qualified Bioassays from DiscoverX has resulted in a faster implementation timeline for QC testing programs and could potentially expedite product commercialization and market release of drug candidates for our clients. We are looking to receive your requests.”

Markus Roucka, CBDO / Managing Director at Vela Laboratories (Vienna, Austria)

Markus Roucka
Vela Laboratories

“We find Eurofins DiscoverX PathHunter® cell-based assays are target-specific and MOA-reflective, and are an integral part of the GMP/GLP-compliant expertise that we provide for our customers. Catalent provides support for an extensive range of large and small molecule analytical products. As a certified provider of Eurofins DiscoverX PathHunter assay services, we are able to leverage our strong track-record to expeditiously implement multiple customer-sponsored validation programs using the PathHunter assay platform to perform highly reproducible potency lot-release assays under GLP/GMP conditions. In our experience, their thaw-and-use Bioassays can reduce assay development timelines by several months. And since their assays are pre-qualified with marketed biologic drugs or reference standards, they also help in risk mitigation when implementing in stability and potency testing programs.”

Ramsey Connor, Biologics Supervisor and RSO at Catalent Pharma Solutions (Morrisville, NC, USA)
Andy Wallace, Ph.D. (Principal Scientist) at Catalent Pharma Solutions (Morrisville, NC, USA)

Ramsey Connor