Charles River and Wheeler Bio Complete Agreement to Accelerate the Journey from Discovery and CMC Development to Manufacturing

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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.

Metadata
Provider: 
Business Wire, Inc.Business Wire, Inc.
Retrieved on: 
星期三, 二月 21, 2024
Information
Tags: 
Health, Medical Devices, General Health, Research, Science, Pharmaceutical, Biotechnology, A-DNA, CRL, LEAP, Entrepreneurship, OK, Chemistry, CDMO, Safety, Wheeler, CGMP, Organization, Patient, Portable, IND, Control, CMC, Pharmaceutical industry
Geotags: 
UNITED STATES, NORTH AMERICA, OKLAHOMA, MASSACHUSETTS
⚠ partially generated by AI ↴
Organisation: 
CHARLES RIVER LABORATORIES INTERNATIONAL, CHARLES RIVER LABORATORIES INTERNATIONAL, INC., CHARLES RIVER, WHEELER BIO
Stock Symbol: 
NYSE:CRL
摘要
Key Points: 
  • 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.
  • Wheeler’s mission is to solve translational challenges inherent in advancing from discovery to CMC development and early-clinical trial material supply.


Charles River Laboratories International, Inc. (NYSE: CRL) today 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.

Approved Quotes

  • “We are thrilled to provide Charles River clients with access to Wheeler’s innovative Portable CMC® platform, which will optimize their workflows and ultimately bring new treatments to patients faster.” –Julie Frearson, Corporate Senior Vice President, Chief Scientific Officer, Charles River
  • “Wheeler is excited to expand our relationship with Charles River and to link with their discovery organization. By integrating discovery CRO and CDMO workflows, we can speed our clients’ path to first-in-human trials, thereby achieving clinical decisions faster. Our combined sales teams look forward to co-promoting these services for the benefit of our biotech partners and their pipelines towards clinical impact.” —Jesse McCool, CEO and Co-Founder, Wheeler Bio

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.

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 first-in-human trials. Innovators benefit from increased momentum during technology transfer, shorter timelines, reduced risk, and lower costs. Additional information can be obtained by visiting wheelerbio.com or by following Wheeler Bio on LinkedIn.

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