Wheeler Bio Seals Agreement with Charles River to Offer Portable CMC® to Discovery Clients to Accelerate Their Journey to First-in-Human Use
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The strategic partnership between Wheeler Bio, Inc. and Charles River Laboratories International, Inc. represents a significant development in the biotech and pharmaceutical services industry. The integration of Wheeler Bio's Portable CMC platform with Charles River's comprehensive services aims to streamline the transition from pre-clinical research to human clinical trials. This collaboration is likely to enhance the value proposition of both companies by offering clients a more efficient path to IND submission, which could lead to increased demand for their combined services.
From a market perspective, this partnership could position Charles River and Wheeler Bio as more competitive entities within the CDMO space. By reducing the number of vendors a client must manage and offering integrated services, the companies could capture a larger market share. This may result in positive investor sentiment towards Charles River's stock (NYSE: CRL), as the market often reacts favorably to strategic partnerships that promise operational efficiencies and potential revenue growth.
Financially, the partnership between Wheeler Bio and Charles River Laboratories could lead to cost savings and revenue synergies. The consolidation of services under one umbrella reduces the complexity and cost associated with managing multiple vendor relationships. For startups and biotech firms, this could translate into lower operational costs and a more predictable budgeting process for CMC development. The ability to align CMC milestones with fundraising efforts is particularly beneficial for early-stage companies that rely on milestones to secure investment.
Investors should monitor the financial performance of Charles River following the announcement, looking for indicators such as increased service uptake and customer retention rates. These metrics will provide insight into the partnership's effectiveness in driving revenue and potentially enhancing earnings. Moreover, the market may anticipate future financial guidance updates from Charles River, reflecting the expected impact of the partnership on the company's bottom line.
From a regulatory standpoint, the use of Wheeler Bio's Portable CMC platform could mitigate technical and regulatory risks associated with the drug development process. Compliance with Chemistry, Manufacturing and Controls (CMC) is a critical aspect of obtaining regulatory approval for new drugs. The platform's validation-ready production process may streamline regulatory submissions, reducing the time and resources spent on addressing regulatory concerns. The partnership's focus on phase-appropriate manufacturing and analytics further aligns with regulatory expectations for drug development, potentially leading to a smoother regulatory review process.
For biotech companies navigating the complex regulatory landscape, this partnership could provide a strategic advantage by simplifying CMC development and ensuring compliance with FDA and other regulatory bodies' guidelines. This could lead to a reduction in the time to market for new therapies, benefiting patients and stakeholders alike.
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 Investigational New Drug (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 Bio's mission is to solve translational challenges inherent in advancing from discovery to CMC development and early-clinical trial material supply. Their 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 including a RightSource™ quality control testing lab. There is an additional satellite lab in Waltham, MA featuring protein sciences and bench scale process capabilities. Wheeler Bio provides startup biotechs with access to a high quality, agile, affordable path to clinical supply with thoughtfully designed, modular work packages featuring the industry leading Leap-In Transposase® mediated gene delivery system from ATUM for robust high titer CHO pool-based workflow parallelization, standard analytics, and discrete CMC milestones that align with innovators' fundraising milestones.
Jesse McCool, CEO and Co-Founder of Wheeler Bio, stated, "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 through better insights, 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."
Julie Frearson, Corporate Senior Vice President, Chief Scientific Officer at Charles River, highlighted the potential of this partnership: "We are thrilled to provide our clients with access to Wheeler's innovative Portable CMC® platform, which will optimize their workflows and ultimately bring new treatments to patients faster."
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 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.
About ATUM
ATUM is a fully integrated Californian based CRDO (Contract Research & Development Organization) biotechnology industry leader. ATUM, over the last two decades, has served life science researchers by delivering high quality services including but not limited to Gene Design and Gene Synthesis, Protein Engineering, Protein Production, Leap-In Transposase®, Cell Line Development, and Master Cell Banking (MCB). With a state-of-the-art machine learning platform, proprietary algorithms, and a fully integrated Laboratory Information Management System (LIMS), ATUM provides platforms and services that span from virtual sequence to manufacturing ready MCB. ATUM has a culture of continuous commitment to innovation where solutions are built on bioengineered solutions to bring speed to market, supporting the biotech ecosystem from pre-clinical research through IND and beyond. Contact us today for more information at www.atum.bio.
For Further Information:
Wheeler Bio, Inc.
Contact: Jaden Polston
jpolston@wheelerbio.com
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FAQ
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