Deployed on-site at a client’s facility, Charles River helps implement a flexible biologics testing lab
CDMO Wheeler Bio and Charles River Laboratories International have announced an agreement to implement RightSourceSM at Wheeler Bio’s current good manufacturing practice (cGMP) biologics manufacturing facility in Oklahoma City.
Deployed on-site at a client’s facility, RightSourceSM 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 like Wheeler Bio.
“We are thrilled to welcome Charles River’s RightSourceSM onsite at our state-of-the-art drug substance manufacturing facility in downtown Oklahoma City,” said Jesse McCool, Co-Founder and Chief Executive Officer at Wheeler Bio. “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.”
The RightSourceSM business model significantly reduces upfront lab set up costs, shields the client from the regulatory burden of managing a QC lab
Wheeler Bio and Charles River will work in close collaboration to set up a cGMP testing lab at Wheeler Bio’s ultra-modern Oklahoma City facility. This platform-based satellite lab will be operated by Charles River employees who will utilise Charles River’s quality management systems, test methods, and standard operating procedures (SOPs) to support all QC testing needs for Wheeler Bio.
Wheeler Bio provides its clients with access to an innovative manufacturing platform called Portable CMCTM, which is coupled with Leap-In Transposase (ATUM) and a layer of digital solutions to accelerate timelines from discovery to IND.
Portable CMCTM is an open-source, predictive, “CMC middleware” that efficiently bridges discovery and early development milestones. Wheeler Bio’s hub-and-spoke operating model connects coastal innovators with translational CMC services that are thoughtfully aligned with clients’ business needs and fundraising strategies.
“The RightSourceSM 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,” said Ian Wyllie, Director Operations, RightSourceSM, Charles River.
The RightSourceSM Laboratory at Wheeler Bio will be operational in Q3 2023 and is anticipated to start in-process and release testing by Q4 2023.