WILMINGTON, Mass.--(BUSINESS WIRE)--Charles River Laboratories International, Inc. (NYSE: CRL) and Wheeler Bio, Inc., a contract development and manufacturing organization (CDMO), today announced an agreement to implement RightSourceSM at Wheeler Bio’s current good manufacturing practice (CGMP) biologics manufacturing facility in Oklahoma City, OK. Deployed on-site at a client’s facility, RightSource is a flexible biologics testing lab operated and managed by Charles River, making fast, reliable quality control (QC) more accessible to a broader reach of companies.
Through this model, Charles River, in close collaboration with Wheeler, will set up a CGMP testing lab, on-site at Wheeler’s facility. This platform-based satellite lab will be operated by Charles River employees who will utilize Charles River’s quality management systems, test methods, and standard operating procedures (SOPs) to support all QC testing needs for Wheeler and its third-party clients.
Outsourced Biologics Testing, Offered On-Site
The RightSource platform is a novel insourcing solution serving biotech and biopharmaceutical companies with the panel of assays they deem necessary for their biologics manufacturing program to have on site. Unlike standard staffing solutions, RightSource offers clients the expertise to bring Charles River’s proprietary assays in-house, with the same quality and scientific platforms used at Charles River’s outsourcing facilities. Having a RightSource program in-house enables clients to leverage Charles River’s wider network of regulatory, scientific consultation and biologics testing support, and will deliver rapid turnaround times and expedited batch release on behalf of Wheeler’s clients.
As Charles River continues investing in digitalization, all RightSource clients will automatically receive enhanced products and services, increasing the value of the partnership as time goes on. The RightSource/Wheeler lab will be operational in the third quarter of 2023 and is anticipated to start in-process and release testing by the end of the year.
Approved Quotes
- “The RightSource business model significantly reduces upfront lab setup costs, shields the client from the regulatory burden of managing a QC lab, and allows for leveraging our robust scientific expertise—directly where clients need it most.”– Ian Wyllie, Director Operations, RightSource, Charles River
- “We are thrilled to have RightSource onsite at Wheeler Bio in Oklahoma City. This initiative adds considerable value to our growing base of clients progressing important therapeutic antibodies and other biologics from discovery to clinical development. It is reassuring knowing that we can rely on Charles River to deliver this important testing service and appropriate levels of quality oversight and compliance. In addition to access to the platform embedded within our operations, we can deliver our clients expedited access to other Charles River services such as viral clearance studies and cell line characterization. This collaboration contributes significantly to our goal of cost-effectively increasing speed and efficiency of delivery of important therapeutics to patients across the globe.” –Jesse McCool, Co-Founder and Chief Executive Officer, Wheeler Bio
About Wheeler Bio
Wheeler Bio is a biomanufacturing pioneer, founded by a team of industry experts and strategic investors who believe a different CDMO model is needed to help innovators reach their clinical milestones faster. Wheeler’s novel hub-and-spoke operational model, centered in the biomanufacturing metro of Oklahoma City, and integrated with biotechs and discovery CROs, will revolutionize the speed of drug development. Wheeler Bio’s technology platform, Portable CMC™, simplifies the path between drug discovery and clinical manufacturing by providing a new bridge for translating discoveries to IND filing. Innovators benefit from increased momentum during technology transfer, shorter timelines, reduced risk, and lower costs. Additional information can be obtained by visiting www.wheelerbio.com, or by following Wheeler Bio on LinkedIn.
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development, and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.
