Certification Program for Cell-Based Assays

Take Your Bioassay Services to the Next Level

Biopharmaceutical companies developing and manufacturing biologics and biosimilars are in need of CRO/CDMO’s that can support their therapeutic programs with robust bioassays. At Eurofins DiscoverX, we have the largest portfolio of qualified bioassays available and custom bioassay development services. With over two decades of experience, biopharma clients seek our advice when moving their drug product downstream and want a CRO/CDMO that can successfully run our bioassays for their therapeutic.


This Certification Program from Eurofins DiscoverX is designed to qualify CRO/CDMO’s to run our bioassays. Certified CRO/CDMO’s are then marketed to biopharma clients focused on their downstream therapeutic efforts

Certified Bioassays - Eurofins DiscoverX





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Certified CROs/CDMO's
CRO/CDMO service providers with certified experience in running Eurofins DiscoverX bioassays


Eurofins Advantar Laboratories Inc. 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.
Eurofins Advantar, Inc.
5451 Oberlin Drive, Suite 100
San Diego, CA. 92121

Phone:   1-858-228-7788
Email:     pharma@eurofins.com
Web:       www.eurofinsus.com/bpt
KBI Biopharma 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.

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KBI Biopharma
Research Triangle Park
4117 Emperor Blvd., Ste 200
Durham, NC 27703 USA

Phone:   1 919-479-9898
Email:     info@kbibiopharma.com
Web:       www.kbibiopharma.com
Bela Laboratories
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.

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VelaLabs GmbH
Brunner Strasse 69, Objekt 3
1230 Wien, Austria

Phone:   +43 1 890 59 79 -11
Email:     office@vela-labs.at
Web:       www.vela-labs.at 

“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)

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.

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Catalent Pharma Solutions
14 Schoolhouse Road
Somerset, NJ 0887 USA
Phone: 1 877-587-1835
Email:  info@catalent.com
Web:    www.catalent.com

“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) and Andy Wallace, Ph.D. (Principal Scientist) at Catalent Pharma Solutions (Morrisville, NC, USA)


CRO = Contract Research Organization; CDMO = Contract Development and Manufacturing Organization

Bioassay Kits Qualified with the Marketed Biologic Therapeutics
  • Supporting CRO/CDMO's Every Step of the Way – End-to-end support from assay qualification to method transfer
  • Industry Leader – Implementing the highest quality bioassays in the industry
  • Certification Program – Qualifying CRO/CDMO's to run Eurofins DiscoverX bioassays to ultimately help CRO/CDMO clients therapeutic efforts

Qualification Data for Bioassay
  • Obtain qualification data for ready-to-use bioassays that have been optimized for a particular therapeutic and can reduce assay development timelines by several months. These simple, easy-to-use assay protocols deliver results fast, enabling implementation into QC lot release and transfer of assays

Accelerate CRO/CDMO's Customer Implementation Phase for QC Lot Release with Qualified Bioassays

Save more than 9 months of assay development time by using Eurofins DiscoverX's qualified bioassay.

Typical Bioassay Development Timeline
ICH = International Council for Harmonization; GMP = Good Manufacturing Practices

Discover How CRO/CDMO's are Implementing Bioassays

Case Studies



Value for Certified CRO/CDMO's

  • Pre-release of new targets before new products go into the Eurofins DiscoverX website
  • Availability of Field Application Specialist (FAS) for additional onsite trouble-shooting or training (fees may apply)
  • Access to generate exclusive MCB/WCB for bioassays that reduces the need for bridging studies
  • Reservation of pre-qualified lots with a minimum of 6 months shelf-life
  • Ability to place bulk orders for QC lot release testing clients

Commitment from Eurofins DiscoverX

  • Once you are a certified CRO/CDMO, when a client asks us for recommendations for CRO/CDMO's experienced in our bioassays, we will provide your company’s name/contact to the client (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, and other customer-education materials

Requirements from Applying CRO/CDMO

  • 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
  • A minimum annual purchase of cell-based assay products


Illustrated 3-Day Theoretical and Wet-Lab Workshop