Companies will work together on critical componentsthat canaccelerateclient-sponsored validation programs through downstream drug development
FREMONT, Calif. and DURHAM, N.C. –October 11, 2021–Eurofins DiscoverX Products,LLC(Eurofins DiscoverX),an industryleader in assays for drug discovery, development, and QC lot release, announced today the expansion of its Bioassay Certification Program through itscertification of KBI Biopharma, Inc. (KBI), a JSR Life Sciences company. KBI is among a specialized group of companies enabled to design workflows and implement Eurofins DiscoverX cell-based assays for multiple client-sponsored validation programs using DiscoverX’s PathHunter®technology platform to deliver highly reproducible potency lot release assays under GLP/GMP conditions.
“We are pleased to receive this certification from Eurofins DiscoverX and to be part of the important work the company is doing to fully leverage the utility of functional cell-based assays in biologics drug development,” said Dirk Lange, President and CEO, KBI Biopharma. “This collaboration reflects KBI’s commitment to rapidly accelerate each client’s drug development program, and we look forward to working with DiscoverX to offer the best scientific solutions to provide world-class results in downstream drug development.”
Demonstrations of potency with specialized, relevant cell-based assays are an integral component of the drug development process. Drug developersmust prove that their product candidates are safe and effective (potent). With potency assays playing acritical part of this process, regulators often require the use of functional, cell-based mechanism of action (MOA)-reflective assays that mimic a physiologically relevant environment for potency lot-release studies. The simplicity of the Eurofins DiscoverX PathHunter assay platform, coupled with its broad menu of assays, makes it an attractive platform for pharma and biotech companies to advance their molecules toward regulatory filings.
The advantage of expanding the Bioassay Certification Program, Eurofins DiscoverX leaders say, is that it offers a potent new tool in meeting the needs of biopharma clients seeking CROs and CDMOs that can run its bioassay potency assays when moving their drug product downstream through the development process. Currently, Eurofins DiscoverX includes over 24 qualified bioassays and 36 target-based bioassays that are implemented in global pharma and biotech companies.