The lab will be operated and managed by Charles River and the companies say this will create fast, reliable quality control (QC) more accessible to a broader reach of companies like Wheeler Bio.
RightSource is described as an insourcing solution serving biotech and biopharmaceutical companies ‘with the panel of assays they deem most necessary for their biologics manufacturing program’ to have on site
Jesse McCool, co-founder and CEO at Wheeler Bio, said: “We are thrilled to welcome Charles River's RightSource onsite at our state-of-the-art drug substance manufacturing facility in downtown Oklahoma City.
“On-site support by the industry's leading testing provider adds considerable value to our growing base of clients advancing important therapeutic antibodies and other biologics into human trials for the first time.”
Wheeler Bio and Charles River will work in close collaboration to set up a current good manufacturing practice (cGMP) testing lab at Wheeler Bio's facility. The platform-based satellite lab will be operated by Charles River employees who will utilize its quality management systems, test methods, and standard operating procedures (SOPs) to support all QC testing needs for Wheeler Bio.
Wheeler Bio said it provides its clients with access to an innovative manufacturing platform called Portable CMC, which is coupled with Leap-In Transposase (ATUM) and a layer of digital solutions to accelerate timelines from discovery to IND. Portable CMC is an open-source, predictive, ‘CMC middleware’ that efficiently bridges discovery and early development milestones.
The company says its hub-and-spoke operating model connects coastal innovators with translational CMC services that are thoughtfully aligned with clients' business needs and fundraising strategies.
Ian Wyllie, director operations, RightSource, Charles River, said: “The RightSource business model significantly reduces upfront lab set up 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."
The RightSource Laboratory at Wheeler Bio will be operational in the third quarter of 2023 and is anticipated to start in-process and release testing by the last quarter of 2023.
