Charles River Laboratories Announces Strategic Lentiviral Vector Manufacturing Collaboration with Gates Institute at University of Colorado Anschutz Medical Campus
Charles River Laboratories (NYSE: CRL) and the Gates Institute at the University of Colorado Anschutz Medical Campus have announced a strategic collaboration to develop and manufacture Good Manufacturing Practice (GMP)-grade lentiviral vectors (LVVs) for use in chimeric antigen receptor (CAR) T-cell therapies targeting hematological cancers.
The Gates Institute will leverage Charles River’s expertise in cell and gene therapy CDMO services to support its mission of advancing cellular and gene therapies. This partnership will utilize Charles River's manufacturing platforms and services, including process development, phase-appropriate research-grade and High-Quality plasmid DNA production, and GMP LVV manufacturing. Materials produced will support an upcoming Investigational New Drug (IND) application for Phase I clinical trials.
Charles River aims to expedite clinical and commercial manufacturing through standardized protocols and optimized methods, reducing development time and costs while ensuring high-quality production. This collaboration aligns with Charles River’s efforts to expand its cell and gene therapy portfolio and simplify complex supply chains.
- Strategic collaboration with Gates Institute to develop GMP-grade LVVs for CAR-T therapies.
- Access to Charles River’s established manufacturing platforms and viral vector CDMO center of excellence.
- Support for an upcoming IND application for Phase I clinical trials.
- Charles River’s 20+ years of expertise in plasmid DNA and viral vector CDMO services, ensuring premium quality production.
- Standardized protocols and high-yield, optimized methods to expedite clinical and commercial manufacturing.
- No specific financial data provided in the PR to evaluate immediate financial impact on CRL.
- Potential risks and challenges in the development and regulatory approval process for new therapies not addressed.
Insights
The collaboration between Charles River Laboratories and the Gates Institute at the University of Colorado Anschutz Medical Campus marks a significant stride in the field of advanced cell therapies. The utilization of lentiviral vectors (LVVs) for chimeric antigen receptor (CAR) T-cell therapies is notably impactful, especially for treating hematological cancers.
LVVs are a type of viral vector used to deliver genetic material into cells. Their use in CAR-T therapies involves reprogramming a patient's T-cells to target and destroy cancer cells. This collaboration could potentially lead to more efficacious therapies and faster development times, reducing the time from lab research to patient treatment. Moreover, the reliability of Charles River's established manufacturing protocols and high-yield methods ensures that the LVVs produced will meet stringent quality standards, which is critical for the success of clinical trials.
For retail investors, this collaboration signals Charles River's continued commitment to expanding its portfolio in the cell and gene therapy market. The company's expertise and proven track record in producing GMP-grade LVVs could provide a competitive edge in this burgeoning field, potentially driving revenue growth as the demand for such therapies increases.
From a financial perspective, this collaboration underscores Charles River Laboratories' strategic positioning in the lucrative cell and gene therapy market. The company’s focus on Good Manufacturing Practice (GMP)-grade production and its investment in high-quality plasmid DNA and viral vector capabilities align well with the growing market demand. According to recent market reports, the global CAR-T cell therapy market is expected to grow substantially in the coming years, driven by increasing approvals and the advancements in technology.
By partnering with an institute like Gates, which integrates research, clinical practice and biomanufacturing, Charles River is likely to enhance its revenue streams through expanded service offerings and increased contract volumes. This collaboration could also reduce research and development costs for the Gates Institute, thereby accelerating the overall development timeline of CAR-T therapies.
For investors, this collaboration can be seen as a strategic move that not only strengthens Charles River’s market presence but also potentially enhances long-term shareholder value. However, it's essential to monitor upcoming clinical trial results and regulatory milestones, as these will play a important role in materializing the financial benefits of this agreement.
Lentiviral vector CDMO collaboration to support advanced cell therapies for hematological cancers
The Gates Institute mission at the University of Colorado Anschutz Medical Campus is to develop and deliver advanced therapies in cell and gene therapy. The Institute brings together researchers, clinicians, and a GMP biomanufacturing facility for first-in-human clinical trials. Through this strategic collaboration, Gates Institute will have access to Charles River’s established manufacturing platforms and dedicated viral vector CDMO center of excellence, utilizing a range of services including process development evaluation of Gates Institute’s LVV backbone, phase-appropriate research grade and High –Quality (HQ) plasmid DNA production, and GMP LVV manufacturing. Materials produced within the collaboration will support an upcoming Investigational New Drug (IND) application for Phase I clinical trials.
Plasmid DNA and Viral Vector Manufacturing Services
With over 20 years of plasmid DNA and viral vector CDMO expertise and validated platform processes including eXpDNA™ and Lentivation™ with a proven track record, Charles River has standardized protocols and high-yield, optimized methods to accelerate speed to clinical and commercial manufacturing by reducing process development time and costs while ensuring premium quality production.
In recent years, Charles River has significantly broadened its cell and gene therapy portfolio with several acquisition integrations and expansions to simplify complex supply chains and meet the growing demand for plasmid DNA, viral vector, and cell therapy services. Combined with the company’s legacy testing capabilities, Charles River offers a premier “concept to cure” advanced therapies solution.
To learn more about LVV design, manufacturing, and regulation, join Charles River for a roundtable webinar to examine key trends, address manufacturing challenges, and overcome quality control and regulatory hurdles: https://bit.ly/3Ttijzz
Approved Quotes
- “The cell therapy ecosystem that Gates Institute has created is exciting and we look forward to helping them advance the development of CAR-T therapies for hematological cancers. Our complementary strengths and concept to cure capabilities are well positioned to help move the science forward into the clinic and beyond for oncology patients.” – Kerstin Dolph, Corporate Senior Vice President, Biologics Solutions, Charles River
- “We value this new partnership with Charles River, an industry leader in biopharmaceutical services. In the near term, this collaboration will accelerate the Gates Institute CAR-T programs with their plasmid and lentiviral vector production. Looking ahead to our long-term collaboration, we remain committed to advancing patient impact more broadly.” – Terry Fry, MD, Executive Director, Gates Institute
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 Gates Institute
Gates Institute is a premier cell therapy translational research institute with biomanufacturing capabilities delivering first-in-human therapies. Based at the University of Colorado Anschutz Medical Campus, we are part of a rich biomedical ecosystem. We bring together and support researchers and clinicians who specialize in regenerative, cell and gene therapies, accelerating their discoveries from concepts to cures.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240625166445/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
Gates Institute Media Contact:
Toni Lapp
Communications Manager
816.507.1054
toni.lapp@cuanschutz.edu
Source: Charles River Laboratories International, Inc.
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