Takeda Opens New R&D Cell Therapy Manufacturing Facility to Support Expansion of Next-Generation Clinical Programs
17 September 2020
Takeda Pharmaceutical Company Limited announced the expansion of its cellular therapy manufacturing capabilities with the opening of a new facility for manufacturing of cell therapy research and development of approximately 2,230 square feet at its research and development headquarters in Boston, Massachusetts. The facility provides comprehensive research and development capabilities and will accelerate Takeda's efforts to develop next-generation cell therapies, initially focused on oncology, with the potential to expand into other therapeutic areas.
"We are collaborating with some of the best scientists and innovators from around the world to establish a highly differentiated line of immuno-oncology, which takes a leap towards new modalities and mechanisms with curative potential," said Dr. Chris Arendt, Head of the Area Unit Takeda's Oncology Therapeutics. "With three oncology cell therapy programs in the clinic and two more aimed at entering the clinic in fiscal 2021, we are working with urgency and purpose for the benefit of patients. This new facility helps us rapidly scale our manufacturing capabilities. to be able to advance simultaneously in several highly differentiated cell therapy programs. "
Cancer cell therapy is a type of immunotherapy that uses genetically modified immune cells to find and destroy cancer cells. Because cell therapies are engineered from living cells, they must be manufactured in a strictly regulated environment to maintain cleanliness, consistency, and contamination control. Each oncology cell therapy platform has unique requirements regarding the processes for formulating, manufacturing, transporting, and ultimately delivering drugs to patients. Next Generation Cell Therapy is one of Takeda's many research platforms in oncology as part of its specialization in redirected immunity. Takeda's portfolio of various immuno-oncology programs leverages innate immunity,
A facility specially designed to streamline the progress of cell therapy research and development
The R&D cell therapy manufacturing plant will produce cell therapies for clinical evaluation, from discovery to fundamental Phase 2b trials. The current plant follows Good Manufacturing Practices (BPFA) and was designed to meet all US, EU and Japanese regulatory requirements for the manufacture of cell therapies, in order to support Takeda's clinical trials throughout the world. It will be instrumental in developing Takeda's cell therapy capabilities and the ability to advance multiple next-generation cancer cell therapy platforms and programs with world-class collaborators, including Nobel Laureate Shinya Yamanaka, MD, Ph.D. ., Kyoto University (induced pluripotent stem cells), Adrian Hayday, Ph.D.,
Takeda and MD Anderson are developing the best-in-class allogeneic cell therapy product (TAK-007), a Phase 1/2 CD-19 chimeric antigen receptor (CAR-NK) targeted natural killer cell therapy with potential for immediate use is being studied in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). In addition, two additional Phase 1 studies of Takeda's cell therapy programs were recently initiated: CAR T 19 (T2) 28z1xx (TAK-940) cells, a next-generation CAR-T signaling domain developed in partnership with Memorial Sloan Kettering Cancer Center (MSK) to treat relapsed or refractory B-cell cancers, and a cytokine and chemokine shielded CAR-T (TAK-102) developed in association with Noile-Immune Biotech to treat GPC3 expressing previously treated solid tumors. Dr. Sadelain and MSK have intellectual property rights and associated interests related to the content of this release under license agreements between MSK and Takeda.
Harnessing the Power of Takeda's Cell Therapy Translational Engine
Proactive and deep collaboration between R&D and commercial manufacturing is critical to developing and delivering next-generation cell therapies. Takeda's Cell Therapy Translational Engine (CTTE) links clinical translational science, product design, development, and manufacturing at every stage of research, development, and commercialization. It offers bioengineering, chemistry, manufacturing and control, data management, analytical, clinical, and translation capabilities in a single space to overcome many of the manufacturing challenges that arise in the development of cell therapies.
"With the proximity and structure of our cell therapy equipment, we can rapidly apply what we learn across a diverse portfolio of next-generation cell therapies comprising CAR natural killer cells, armored CAR T cells, and gamma delta T cells, among others, "underlined Stefan Wildt, Ph.D., Head of Pharmaceutical Sciences and Translational Motor, Cell Therapies at Takeda. "The knowledge gained from manufacturing and clinical development can be quickly shared among our global research, manufacturing and quality teams, a core capability in our effort to deliver transformative treatments for patients, as quickly as possible."
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited is a leading global R&D-driven and values-based biopharmaceutical company based in Japan. They are committed to bringing better health and a more prosperous future to patients by translating science into highly innovative medicines. Takeda concentrates its R&D efforts in four therapeutic areas: oncology, gastroenterology, rare diseases and neurosciences. We also invest in R&D focused on plasma-derived therapies and vaccines. We focus on developing highly innovative medicines that help make a difference in people's lives by pushing the frontier of new treatment options and leveraging our enhanced, cooperative R&D engine and capabilities to build a strong portfolio. , of diverse modalities.
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