Japanese pharmaceutical firm Takeda opened a new R&D cell therapy manufacturing facility in Boston, Massachusetts to expand its cell therapy manufacturing capabilities.

The new 24,000ft2 manufacturing facility, designed to primarily focus on oncology, with plans to expand into other therapeutic areas, is said to provide research and development capabilities for the company and advance its next-generation cell therapies development programmes.

Engineered from living cells, cell therapies require a highly regulated environment during production, to maintain sanitation, consistency and contamination control. Oncology cell therapy is a type of immunotherapy that uses genetically modified immune cells to find and kill cancer cells.

Takeda Oncology Therapeutic Area Unit head Chris Arendt said: “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.

“With three oncology cell therapy programs in the clinic and two more targeted to enter the clinic in the 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 new R&D cell therapy manufacturing facility will support global clinical trials

Takeda is researching next-generation cell therapy in oncology, which requires unique process requirements in formulation, manufacturing, transportation and administration to patients, with a focus on redirected immunity.

The company’s portfolio of immuno-oncology programmes leverages the innate immunity, immune engager platforms, innate immuno-modulation, novel-scaffold immune checkpoint platforms and oncolytic viruses.

The new current Good Manufacturing Practices (cGMP) facility is aimed at manufacturing cell therapies, to support the company’s global clinical trials, and is designed to meet all the US, EU and Japanese regulatory requirements for the production of cell therapies.

The new R&D cell therapy manufacturing facility is said to strengthen Takeda’s cell therapy capabilities and advance next-generation oncology cell therapy programmes with global collaborators.

The company said that its cell therapy translational engine (CTTE) combines clinical translational science, product design, development, and manufacturing with all the phases of research, development and commercialisation services.

Also, the business division offers bioengineering, chemistry, manufacturing and control (CMC), data management, analytical and clinical and translational capabilities to overcome manufacturing challenges in cell therapy development.

Takeda Pharmaceutical Sciences cell therapies and translational engine head Stefan Wildt said: “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, armoured CAR-Ts and gamma delta T cells, among others.

“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.”