Takeda Pharmaceutical is expanding 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. Company officials say the facility 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, PhD, 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.”
Oncology cell therapy is a type of immunotherapy that uses genetically modified immune cells to find and kill cancer cells. Because cell therapies are engineered from living cells, they need to be manufactured in a highly regulated environment to maintain cleanliness, consistency, and contamination control. Each oncology cell therapy platform has unique process requirements for how they are formulated, manufactured, transported, and ultimately administered to patients.
Next-generation cell therapy is one of the multiple investigational platforms that Takeda is researching in oncology as part of its focus on redirected immunity. Takeda’s pipeline of immuno-oncology programs harnesses innate immunity, including through cell therapies, immune engager platforms, innate immuno-modulation, novel-scaffold immune check point platforms and oncolytic viruses, according to Stefan Wildt, PhD, head of pharmaceutical sciences and translational engine, cell therapies at Takeda.
The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase IIb trials. The 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.
Proactive and deep collaboration between research and development and commercial manufacturing is critical to developing and delivering next-generation cell therapies, pointed out Arendt. Takeda’s Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development, and commercialization, he continues, adding that 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 [natural killers] NKs, armored CAR-Ts and gamma delta T cells, among others,” says Wildt. “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.”