Contract Development and Manufacturing (CDMOs) and Contract Research Organizations (CROs) such as Charles River remain the backbone of biopharmaceutical research right through to commercialization, providing a reliable source of know-how and expertise to strengthen therapeutic development.

We are proud to partner with T cell immunotherapy developers Captain T Cell and the Gates Institute, providing phase-appropriate plasmid DNA and viral vector materials to further clinical development of their gene-modified cell therapies.

"Charles River has decades of success reliably manufacturing plasmid DNA, viral vectors, and cell therapies, helping to safeguard our customer programs and bring potential therapies to patients with limited options," commented Kerstin Dolph, CSVP, Global Manufacturing. On the recent client collaboration, she added: "We are thrilled to work with the Captain T Cell team to support the manufacture of its TCR-T cell cancer immunotherapy."

An Award-winning Approach to Cancer Immunotherapy

With the goal to give new patient groups access to T cell immunotherapies, Captain T Cell, spinoff from the renowned Max Delbrück Center Berlin, is developing efficacy-enhanced treatment options for solid tumor therapies, including a T cell receptor (TCR-T) cell therapy preparing to enter Phase I clinical trials.

Leveraging a next-gen technology toolbox, the developer generates T cells displaying tumor-specific T cell receptors (TCRs) as well as enhanced ability to cope with the hostile tumor microenvironment of hard-to-treat solid tumors. Once infused into a patient's body, these tumor-specific T cells seek to find and destroy tumor cells and may provide an alternative for patients with tumors that no longer respond to other therapies.

To bring its gene-modified cell therapy to clinic, Captain T Cell, part of Charles River's CGT Accelerator Program (CAP), will leverage the company's scientific advisory services, plasmid DNA, and retrovirus CDMO capabilities, finetuned over decades supporting cell and gene therapy (CGT) developers from pre-clinical to commercial scale.

"Captain T Cell is devoted to developing a new generation of toolbox-engineered T cell-based immunotherapies for solid tumor patients," commented Felix Lorenz, CEO, Captain T Cell, in a press release announcing the agreement. "We have the utmost confidence in the expertise of Charles River as we work to bring our lead candidate to the clinic."

Gene-Modified Cell Therapies for Hematological Cancers

Similarly striving in its mission to develop and deliver advanced therapies, the Gates Institute at the University of Colorado Anschutz Medical Campus has assembled researchers, clinicians, and a Good Manufacturing Practice (GMP) biomanufacturing facility for first-in-human clinical trials for novel chimeric antigen receptor (CAR) T cell therapies for hematological cancers.

Through a recently announced strategic manufacturing relationship, Gates Institute will have access to Charles River's established eXpDNA™ plasmid and Lentivation™ lentiviral vector manufacturing platforms and dedicated CDMO centers of excellence. Materials produced will support an upcoming Investigational New Drug (IND) application for Phase I clinical trials.

"We value this new partnership with Charles River, a standout in biopharmaceutical services," noted Terry Fry, MD, Executive Director, Gates Institute, in a recent press release announcing the strategic alliance. "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."

Kerstin Dolph also shared: "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."

For more information on our plasmid DNA, viral vector, and cell therapy development and manufacturing platforms and services, plus integrated testing capabilities, please visit Cell and Gene Therapy CDMO Solutions.

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