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

Rhea-AI Summary

Charles River Laboratories International, Inc. (CRL) announces a strategic agreement with Wheeler Bio, Inc. to provide early-stage biotech companies with access to Wheeler's Portable CMC® platform, accelerating therapeutic discovery timelines. This collaboration aims to streamline preclinical to clinical manufacturing processes, reducing vendor complexities and integrating CMC development early in discovery. Wheeler's mission is to solve translational challenges in advancing from discovery to CMC development and early-clinical trial material supply.

Insights

Market Research Analyst

From a market perspective, the strategic agreement between Charles River Laboratories and Wheeler Bio represents a significant move in the biopharmaceutical services industry. By combining Charles River's expertise in antibody discovery and Wheeler's Portable CMC platform, the partnership aims to streamline the process from preclinical stages to first-in-human clinical trials. This is expected to reduce time-to-market for new therapies, a critical factor in the highly competitive biotech sector.

The collaboration could potentially lead to increased demand for Charles River's services, thereby impacting its revenue growth. Investors should monitor the adoption rate of this integrated service offering and any reported efficiency gains, as these can serve as indicators of the partnership's success and its influence on Charles River's market position.

Financial Analyst

Financially, the alliance could be a driver for both revenue growth and cost efficiencies. By providing a more seamless transition from discovery to clinical trial phases, Charles River could attract a larger customer base among early-stage biotech companies. The financial impact will depend on the pricing strategy for the combined service offering and the operational cost savings from reduced complexity in managing vendor relationships.

Investors should look for future financial disclosures from Charles River to assess the impact of this agreement on margins and earnings. It will be important to compare these metrics against industry benchmarks to evaluate whether this strategic move provides Charles River with a distinct financial advantage over its competitors.

Biotech Legal Expert

Legally, the integration of Wheeler's Portable CMC platform with Charles River's services could have implications for intellectual property (IP) management and regulatory compliance. The Portable CMC platform is described as 'validation-ready', which suggests that it meets certain regulatory standards. This could mitigate technical and regulatory risks associated with the development and manufacturing of biologics.

For stakeholders, understanding the IP landscape and how the partnership manages proprietary technology and data is crucial. It is also important to note how the collaboration aligns with FDA regulatory pathways and guidelines for the development of biologics, as this could influence the speed and success rate of IND submissions.

WILMINGTON, Mass. & OKLAHOMA CITY--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240221892461/en/

Charles River Investor Contact:

Todd Spencer

Corporate Vice President,

Investor Relations

781.222.6455

todd.spencer@crl.com

Charles River Media Contact:

Amy Cianciaruso

Corporate Vice President,

Chief Communications Officer

781.222.6168

amy.cianciaruso@crl.com

Source: Charles River Laboratories International, Inc.

FAQ

What strategic agreement did Charles River Laboratories International, Inc. (CRL) announce?

Charles River Laboratories International, Inc. (CRL) 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.

What is the focus of Wheeler Bio, Inc. in the strategic agreement with Charles River Laboratories International, Inc. (CRL)?

Wheeler Bio, Inc. in the strategic agreement with Charles River Laboratories International, Inc. (CRL) is focused on providing clients access to Wheeler’s Portable CMC® platform for accelerating therapeutic discovery timelines.

What is the mission of Wheeler Bio, Inc. in the collaboration with Charles River Laboratories International, Inc. (CRL)?

Wheeler Bio, Inc.'s mission in the collaboration with Charles River Laboratories International, Inc. (CRL) is to solve translational challenges inherent in advancing from discovery to CMC development and early-clinical trial material supply.

Where is Wheeler Bio, Inc. based and what facilities do they have?

Wheeler Bio, Inc. is based in Oklahoma City, OK, with a CGMP facility-of-the-future and process development labs. They also have a satellite lab in Waltham, MA featuring protein sciences and bench scale process capabilities.

What key services does Wheeler Bio, Inc. provide to startup biotechs?

Wheeler Bio, Inc. provides startup biotechs with access to a high quality, agile, affordable path to clinical supply with Leap-in Transposase® for workflow parallelization, standard analytics, and discrete CMC milestones aligning with innovators’ fundraising milestones.