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 the 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.
- 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
“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)
“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)
CRO and CDMO service providers with certified experience in running Eurofins DiscoverX bioassays.
KBI Biopharma BV provides biopharmaceutical characterization, analytical development, formulation development, and cGMP quality control testing for drug substance, drug product release.
Eurofins PHAST GmbH takes on challenging tasks for its customers in the pharmaceutical industry. At our Homburg site, colleagues from various technical disciplines work on fulfilling customer projects for human and animal pharmaceuticals in a professional manner, on time and on budget.
Eurofins BioPharma Product Testing Munich GmbH services portfolio includes a variety of biological safety, quality and efficacy testing for (bio-) pharmaceuticals, chemicals, medical devices, cosmetics.
Eurofins BioPharma Product Testing Italy has been active in the testing of biologics for several years with a broad service package from molecular biology, cell biology up to biochemistry, and bioassays, being a consistent partner in supporting manufacturer to fulfill several regulatory requirements.
Eurofins Advantar Laboratories Inc., located in San Diego, was founded in 2008 and is a contract provider of drug development and manufacturing services offering GMP testing services that include: cell based potency assays, HPLC, LCMS, ICH stability studies, formulation development, and the manufacture of sterile clinical supplies.
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.
Vela Laboratories, headquartered in Vienna, is a GMP-certified contract laboratory offering protein characterization services (Biopharmaceuticals, Biologics, Biogenerics/Biosimilars) in all stages of product development (pre-clinical, clinical) up to market approval.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply.
Benefits for Certified CROs/CDMOs
- Access to pre-release products before they are commercially released by Eurofins DiscoverX to the broader market
- Availability of dedicated scientific support (Scientific Managers, Field Application Scientists, and R&D) for troubleshooting or training (fees may apply)
- Commission exclusive cell banks for bioassays – ensuring long-term support
- Reservation of pre-qualified bioassay lots that reduces the need for bridging studies
- Place customized bulk orders for bioassays for QC lot release testing clients
Commitment from Eurofins DiscoverX
- Eurofins DiscoverX will provide details (name and contact) of certified CRO/CDMOs to the client seeking a recommendation for transferring bioassays (non-exclusive)
- Your name/logo will appear on our website and in our marketing materials, stating your company’s status as a certified CRO/CDMO
- You will have access to co-sponsor seminars, white-papers, case studies, applications notes, and other customer-education materials
Accelerate Your Client’s QC Lot Release Testing with EDRX Qualified Bioassays
Save more than 12 months of assay development time by using Eurofins DiscoverX’s qualified bioassay.
ICH = International Council for Harmonization; GMP = Good Manufacturing Practices
Requirements for Applying CRO/CDMOs
- A commitment to incorporate Eurofins DiscoverX bioassays and cell lines into their assay development portfolio
- Expectation to share application data with Eurofins DiscoverX (without violating client confidentiality) that could be used to show the value of these products
- To co-sponsor seminars and publications as appropriate
Get your Certification virtually by attending an online workshop or have our Field Application Scientist visit your site for a theoretical and wet-lab workshop.
Bioassays are critical components of the quality control system for characterizing biologics. This roundtable involves an interactive panel discussion with…Watch Now
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