Eurofins DiscoverX Further Expands Its Bioassay Certification Program with Catalent Biologics
Release date: 6/29/2020
Eurofins DiscoverX announces Catalent Biologics as a North American Certified Biologics Analytical Laboratory
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June 29, 2020, 09:00 ET
Fremont, CA – June 29, 2020 – Eurofins DiscoverX, the products company of Eurofins Discovery, today announced the expansion of their CRO Certification Program for Bioassays with Catalent Biologics as a North American provider certified in the program. As a certified provider of PathHunter® assay services, Catalent Biologics’ Morrisville/RTP facility in North Carolina has successfully demonstrated their capability to expeditiously implement multiple client-sponsored GLP validation programs using the PathHunter assay platform to perform highly reproducible potency lot release assays under GLP/GMP conditions.
Eurofins DiscoverX launched their CRO certification program to support the growing needs of biotech and pharma companies to partner with CROs and CDMOs to run potency lot release programs for bioinnovator and biosimilar drugs. Since its launch, the program has attracted the attention of multiple global partners interested in becoming certified. This certification provides biopharma developers a platform to access experienced biologics analytical labs that can, in an expedited manner, provide potency and nAB study support.
This bioassay certification program plays a critical role in that biopharma product developers have to prove their drug products are safe and effective (potent). While potency can be determined using a binding assay, regulators often require the use of a functional cell-based mechanism of action (MOA)-reflective assay, like PathHunter bioassays, that mimics conditions in living cells when the molecule allows for it for potency lot release studies. The simplicity of the PathHunter platform, coupled with its broad menu of assays, makes it an attractive platform for pharma and biotech companies to drive their drug molecules for filings by using the assays.
For more information on Eurofins DiscoverX’s CRO Certification program, visit discoverx.com/crocertification
Wendy Parenteau, Director Marketing Communications
Eurofins – the global leader in bio-analysis
Eurofins Scientific, through its subsidiaries (hereinafter “Eurofins” or “the Group”), believes it is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing. With over 47,000 staff across a network of more than 900 independent companies in over 50 countries generally specialised by end client markets and operating more than 800 laboratories, Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of a wide range of products, as well as providing innovative clinical diagnostic testing services. The Group’s objective is to provide customers with high-quality and innovative services, accurate results on time and, when requested, expert advice by its highly-qualified staff.
Eurofins is committed to pursuing its dynamic growth strategy by expanding both its technology portfolio and its geographic reach. Through R&D and acquisitions, the Group draws on the latest developments in the field of biotechnology and analytical chemistry to offer its clients unique analytical solutions and a very large range of testing methods.
As one of the most innovative and quality-oriented international groups in its industry, Eurofins is ideally positioned to support its clients’ increasingly stringent quality and safety standards and the increasing demands of regulatory authorities and healthcare practitioners around the world.
Shares in Eurofins Scientific are listed on the Euronext Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg ERF FP). For more information, please visit www.eurofins.com.
About Catalent Biologics
Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and 35+ commercially approved products. Catalent has recently acquired MaSTherCell, a technology-focused cell therapy development and manufacturing partner with expertise in autologous and allogeneic cell therapy that complements Catalent’s industry-leading expertise and commercial success in gene therapy development, manufacturing and adeno-associated virus (AAV) vector production. Together, Paragon Gene Therapy and MaSTherCell have produced over 100 GMP batches across 60+ clinical and commercial programs. For more information on Catalent Biologics, visit www.catalent.com/biologics
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. Catalent employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit https://www.catalent.com/