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KBI Biopharma Completes Eurofins DiscoverX Products Specialized Bioassay Certification Program

Companies will work together on critical componentsthat canaccelerateclient-sponsored validation programs through downstream drug development

FREMONT, Calif. and DURHAM, N.C.October 11, 2021Eurofins 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.

Topics: Corporate

MBL establishes a new R&D and manufacturing site for in vitro diagnostic products and services in Shenzhen, China

Shenzhen, China - September 17, 2021 - Medical and Biological Laboratories Co., Ltd. (President & CEO: Kimimasa Yamada, “MBL”), a JSR Life Sciences Company, announced that its subsidiary MBL Shenzhen Biotech Co., Ltd. (“MBLS”) has been established in full-scale operation as a new R&D and manufacturing site for in vitro diagnostic products and services in China.

Topics: Corporate RR & IVD

Crown Bioscience Invests in Commercial Leadership

New Vice President to lead North America and Europe Business Development

Topics: Corporate

Selexis and KBI Biopharma Enter into Agreements with Immatics for Integrated Approach to Advance Immatics TCR Bispecific Program Towards IND

Geneva, Switzerland, and Durham, NC – June 29, 2021  – Selexis SA and KBI Biopharma (KBI), both JSR Life Sciences companies, announced today that they have signed service agreements with Immatics N.V. (NASDAQ: IMTX; “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies. The agreements focus on using integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, called TCER® (T Cell Engaging Receptors), that simultaneously recruit, activate and stimulate the patient’s own T cells to detect, target and attack tumor cells. Under the agreements, Selexis will utilize its SUREtechnology Platform™ and KBI will leverage its advanced analytics, process, formulation and cGMP manufacturing for Immatics’ IMA402 program. 

Topics: Corporate

KBI Biopharma Enters Commercial Manufacturing Agreement with AM-Pharma to Prepare for the Commercial Launch of Lead Program in Acute Kidney Disease

Agreement supports future commercial manufacturing for AM-Pharma’s recombinant alkaline phosphatase program

Utrecht, The Netherlands and DURHAM, NC – June 17, 2021 – KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, and AM-Pharma, an emerging leader focused on the development of therapeutics that protect organ function in patients with severe medical conditions, have signed a commercial manufacturing agreement to advance AM-Pharma’s recombinant human Alkaline Phosphatase (recAP) program towards commercialization. AM-Pharma is developing recAP for the potential treatment of Sepsis-Associated Acute Kidney Injury (SA-AKI). 

Topics: Corporate

CrownBio Acquires OcellO B.V. to Expand Its Preclinical In Vitro Drug Development Service Offerings

Acquisition augments CrownBio’s preclinical in vitro service platforms, adding high content imaging and advanced tumor organoid analytics to three-dimensional immuno-oncology drug assays

San Diego, California, May 5, 2021 – Crown Bioscience (CrownBio), a JSR Life Sciences company and leader in preclinical services that help biopharmaceutical companies accelerate new drug development programs, has acquired OcellO B.V., a privately owned contract research

Topics: Corporate

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