Takeda Established Capabilities to Engine Cell Therapy Manufacturing

In particular, immunology cell therapy is a rapidly growing field, where foundational discoveries about our immune system fighting cancer and novel approaches to the manufacturing of complex biologics yield promising breakthroughs. However, the main challenge in manufacturing cell therapies is engineering medicines to ensure consistency, cleanliness, and robust anti-contamination measures.

By Pavel Ryzhov, Ph.D.

Therefore, success in this space requires close collaboration across disciplines, commitment to significant upfront investments into R & D and manufacturing, and an ability to scale and commercialize developed medicines rapidly. As immunotherapy begins to mature, companies are looking to establish in-house capabilities supporting cell therapy manufacturing and follow current Good Manufacturing Practices (cGMP).

This is the case with Takeda, a global R&D-driven biopharmaceutical company, which recently announced an opening of 24,000 square-foot R&D cell therapy manufacturing facility in Boston, Massachusetts [1]. The purpose of the building is to provide R & D capabilities in developing next-generation cell therapies in the oncology area, with further expansion into other disease indications and therapeutic areas. The production will focus on therapies for pre-clinical and clinical studies through Phase II trials. The cGMP environment in the facility is said to meet US, EU and Japanese regulatory requirements, thus positioning Takeda to support its multinational trials.

Of note is Takeda’s partnership with many prolific international collaborators to further develop several promising cell therapy platforms. These include induced pluripotent stem cells, gamma delta T-cells, armored CAR-Ts, next-generation CARs and CAR-NKs. According to Stefan Wildt, Head of Pharmaceutical Sciences and Translational Engine, Cell Therapies at Takeda, “the proximity and structure” of their cell therapy teams allows the company to “quickly apply what [they] learn across a diverse portfolio.”

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Takeda’s collaborations in several clinical studies were also mentioned in the press release. In partnership with MD Anderson Cancer Center, a Phase 1/2 study is underway for CD19-targeted CAR-directed natural killer (CAR-NK) allogeneic cell therapy (TAK-007) for relapsed/refractory non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. Memorial Sloan Kettering Cancer Center is involved in phase 1 trial with Takeda to evaluate next-gen CAR-T signaling domain – 19(T2)28z1xx CAR T cells (TAK-940) in relapsed/refractory B-cell cancers. Another phase 1 study partnership to combat GPC3-expressing previously treated solid tumors is with Noile-Immune Biotech and is evaluating cytokine and chemokine armored CAR-T (TAK-102).

It was also noted that interaction between R & D and commercial manufacturing departments is vital for these therapies’ success due to multiple upstream and downstream production challenges. These challenges Takeda addresses with its Cell Therapy Translational Engine, which unifies bioengineering, chemistry, manufacturing and control (CMC), data management and other translational capabilities under one roof. Furthermore, the facility provides rapid scalability of manufacturing to develop several cell therapy programs at once. Dr. Wildt further underscored that by saying that “insights gained in manufacturing […] can be quickly shared across our global research, manufacturing and quality teams”.

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Reference:

1.https://www.takeda.com/newsroom/newsreleases/2020/takeda-opens-new-rd-cell-therapy-manufacturing-facility-to–support-expansion-of-next-generation-clinical-programs/

Author

Pavel Ryzhov