Certified CROs
CRO service providers with certified experience in running Eurofins DiscoverX bioassays
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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: m.roucka@vela-labs.at
Web: www.vela-labs.at
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“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) |
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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
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“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)
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Bioassay Kits Qualified with the Marketed Biologic Therapeutics
- Supporting CROs 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
- CRO Certification Program – Qualifying CROs to run Eurofins DiscoverX bioassays to ultimately help CRO 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 CROs 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.
ICH = International Council for Harmonization; GMP = Good Manufacturing Practices
Discover How CROs are Implementing Bioassays
Case Studies
- Case Studies for Evaluating Checkpoint Receptor Bioassays: Fit-for-Purpose Assays Intended for QC Lot Release Programs for Therapeutic Drug Candidates (Sartorius Stedim BioOutsource Limited and Eurofins DiscoverX)
Webinar
- Establishing Qualified Bioassays for Checkpoint Receptors to Implement in QC Lot Release: Case Studies on PD-1 and SIRPα (Sartorius Stedim BioOutsource Limited and Eurofins DiscoverX)
- Accelerate Biologics and Biosimilars Development: Case Studies Implementing Robust and Simple Potency Bioassays (Covance Laboratories and Eurofins DiscoverX)
Value for Certified CROs
- 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, when a client asks us for recommendations for CROs 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
- You will have access to co-sponsor seminars, white-papers, and other customer-education materials
Requirements from Applying CRO
- 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
