Image Credit: Adobe Stock Images/Ayesha.com
Charles River Laboratories International, Inc., a contract development and manufacturing organization (CDMO), and the Gates Institute at the University of Colorado Anschutz Medical Campus have reached a lentiviral vector manufacturing agreement.1
Per the deal, Gates Institute will utilize Charles River’s cell and gene therapy (CGT) expertise—especially in the manufacturing space—to develop good manufacturing practice (GMP)-grade lentiviral vectors (LVVs) for application in novel chimeric antigen receptor (CAR) T-cell therapies for hematological cancers.
“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 cancer,” said Kerstin Dolph, corporate SVP, biologics solutions, Charles River. “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.”
With the help of researchers and clinicians, along with a GMP biomanufacturing plant, the aforementioned institute’s objective is to further grow therapies in the CGT sector. Via this new partnership, Gates Institute will be able to utilize the CDMO’s viral vector CDMO center of excellence and manufacturing platforms, which encompass services such as process development evaluation of Gates Institute’s LVV mainstay, phase-appropriate research grade and High–Quality (HQ) plasmid DNA production, and GMP LVV manufacturing. The designed materials that come out of this collaboration will directly go toward a new investigational new drug (IND) application for Phase I clinical trials.
“We value this new partnership with Charles River, an industry leader in biopharmaceutical services,” noted Terry Fry, MD, executive director of the Gates Institute. “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.”
The CDMO brings over two decades of plasmid DNA and viral vector development experience, with various validated, branded platform processes, such as Lentivation and eXpDNA. Its main priority continues to lie in developing the proper tactics to accelerate the timeline involved for both clinical and commercial manufacturing by decreasing process development time and costs.
Charles River has been on mission to widen its CGT portfolio in the form of various business dealings, including with the plasmid DNA and retrovirus vector production program agreement it recently reached with Captain T Cell.2 According to the company, it aims to design T cells that show tumor-specific T cell receptors (TCR), along with greater persistence and the ability to manage the tumor microenvironment that involved with difficult-to-treat solid tumors.
According to Charles River’s CGT Accelerator Program, Captain T Cell will have access to Charles River’s services in the midst of manufacturing a TCR-T cell therapy for solid tumor patients for a Phase I clinical trial.
“Captain T Cell is devoted to developing a new generation of toolbox-engineered T cell-based immunotherapies for solid tumor patients. We have the utmost confidence in the expertise of Charles River as we work to bring our lead candidate to the clinic,” commented Felix Lorenz, CEO, Captain T Cell.
References
1. Charles River Laboratories Announces Strategic Lentiviral Vector Manufacturing Collaboration with Gates Institute at University of Colorado Anschutz Medical Campus. Charles River. June 25, 2024. Accessed June 26, 2024. https://ir.criver.com/news-releases/news-release-details/charles-river-laboratories-announces-strategic-lentiviral-vector
2 Charles River and Captain T Cell Announce Plasmid DNA and Viral Vector Manufacturing Alliance for Gene-Modified Cell Therapy. Charles River. June 17, 2024. Accessed June 26, 2024. https://ir.criver.com/news-releases/news-release-details/charles-river-and-captain-t-cell-announce-plasmid-dna-and-viral