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RightSource enables clients to leverage Charles River’s wider network of regulatory, scientific consultation and biologics testing support.
May 31, 2023
By: Anthony Vecchione
Charles River Laboratories International, Inc. and Wheeler Bio, Inc., a contract development and manufacturing organization (CDMO), entered into an agreement to implement RightSource 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. 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. 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. “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,” said Ian Wyllie, director operations, RightSource, Charles River. “We are thrilled to have RightSource onsite at Wheeler Bio in Oklahoma City, said Jesse McCool, Co-Founder and CEO, Wheeler Bio. “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.”
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