Charles River Laboratories International, Inc. announced a strategic agreement with Wheeler Bio, Inc., an antibody contract development and manufacturing organization (CDMO) focused on preclinical and early clinical supply of recombinant proteins, providing clients access to Wheeler’s Portable CMC® (Chemistry, Manufacturing and Controls) platform. This new alliance provides early-stage biotechnology companies a unique solution to rapidly transition from pre-clinical activities to first-in-human clinical trials.
Combining Charles River’s industry-leading experience in antibody discovery services, safety, and analytics with Wheeler’s Portable CMC® platform will accelerate therapeutic discovery to IND submission timelines. This umbrella offering efficiently connects the preclinical, clinical manufacturing, and release testing journeys, significantly reducing the complexity of managing multiple vendor relationships. Integrating CMC development early in discovery enables therapeutic developers to collaborate with experts across the organizations to utilize phase-appropriate manufacturing and analytics. The services and expertise come together to provide a single concept-to-commercial offering.
Wheeler’s mission is to solve translational challenges inherent in advancing from discovery to CMC development and early-clinical trial material supply. Wheeler’s Portable CMC® is a validation-ready production process which reduces technical and regulatory risk. The organization operates the Portable CMC® platform in Wheeler’s state-of-the-art process development labs in Oklahoma City, OK, which also houses a CGMP facility-of-the-future with on-site Charles River RightSource™ quality control testing labs. There is an additional satellite lab in Waltham, MA featuring protein sciences and bench scale process capabilities. Wheeler provides startup biotechs with access to a high quality, agile, affordable path to clinical supply with thoughtfully designed, modular work packages featuring Leap-in Transposase® for pools-based workflow parallelization, standard analytics, and discrete CMC milestones that align with innovators’ fundraising milestones.
