RightSourceSM is Charles River's insourced, purpose-built lab offering that provides industry-leading expertise conveniently placed within a Wheeler Bio's new cGMP drug substance facility.
OKLAHOMA CITY, May 31, 2023 /PRNewswire/ -- Wheeler Bio, Inc., a contract development and manufacturing organization (CDMO), and Charles River Laboratories International, Inc. (NYSE: CRL) 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, 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."
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 utilize 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 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. 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.
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.
For Further Information:
Wheeler Bio, Inc.
Contact: Jesse McCool
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SOURCE Wheeler Bio