Eurofins DiscoverX Products LLC, a leader in assays for drug discovery, development, and QC lot release, has expanded its Bioassay Certification Program through its certification 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 developers must prove that their product candidates are safe and effective (potent). With potency assays playing a critical 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.
 
The program offers a trusted partner to organizations looking for long-term support to accelerate biologics projects. The companies share a commitment to technical excellence and to doing everything we can to help clients.
 
KBI Biopharma earned the certification by demonstrating its proficiency in advancing programs for potency under GMP conditions, using the Eurofins DiscoverX PathHunter assay platform, including the successful transfer of multiple client-sponsored GMP validated programs. To earn the certification KBI personnel received training to ensure highly reproducible, cell-based potency lot-release assays for complex biologics.