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Takeda Opens New R&D Cell Therapy Manufacturing Facility in Boston

Takeda Opens New R&D Cell Therapy Manufacturing Facility in Boston

  • Posted by ISPE Boston
  • On October 1, 2020

Takeda has expanded its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston. The facility provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas.

“We are collaborating with some of the best scientists and innovators around the world establishing a highly differentiated immuno-oncology pipeline leapfrogging into new modalities and mechanisms with curative potential,” said Chris Arendt, Ph.D., Head of Takeda’s Oncology Therapeutic Area Unit. “With three oncology cell therapy programs in the clinic and two more targeted to enter the clinic in fiscal year 2021, we are working with urgency and purpose for patients. This new facility helps us rapidly scale our manufacturing capabilities so we can simultaneously advance multiple highly differentiated cell therapy programs.”

The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (cGMP) facility is designed to meet all U.S., E.U. and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world. It will be instrumental in building Takeda’s cell therapy capabilities and capacity to advance multiple next-generation oncology cell therapy platforms and programs with world-class collaborators.

Proactive and deep collaboration between research and development and commercial manufacturing is critical to developing and delivering next-generation cell therapies. Takeda’s Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development and commercialization. It provides bioengineering, chemistry, manufacturing and control (CMC), data management, analytical and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

“The proximity and structure of our cell therapy teams allow us to quickly apply what we learn across a diverse portfolio of next-generation cell therapies including CAR NKs, armored CAR-Ts and gamma delta T cells, among others,” said Stefan Wildt, Ph.D., Head of Pharmaceutical Sciences and Translational Engine, Cell Therapies at Takeda. “Insights gained in manufacturing and clinical development can be quickly shared across our global research, manufacturing and quality teams, a critical ability in our effort to deliver potentially transformative treatments to patients as fast as we can.” (Source: Takeda Website, 15 September, 2020)

 

 

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