The basics:

• Cellares to open first overseas CAR-T factory in Japan
• Facility will feature automated Cell Shuttle and Cell Q platforms
• Expects to employ 350, streamline cell therapy production

Cellares is advancing the global expansion of its state-of-the-art automated cell therapy manufacturing platform.

The company announced May 29, in collaboration with Mitsui Fudosan, the establishment of Japan’s first next-gen commercial production site for CAR-T cell therapies. It also marks Cellares’ first overseas facility as it builds out its global manufacturing network.

The facility is under construction in Kashiwa City, about 18 miles northeast of central Tokyo. It will utilize Cellares’ state-of-the-art technology platforms, the Cell Shuttle as well as Cell Q, to automate cell therapy manufacturing and quality control. Cellares’ technology reduces batch prices by up to 50% while eliminating manufacturing bottlenecks faced by conventional contract development and manufacturing organizations (CDMO) that use manual processes.

NJBIZ has reported extensively on the remarkable growth and development of Cellares. The company opened its first commercial-scale integrated development and manufacturing organization (IDMO) Smart Factory in Bridgewater.

Key things to know about the newest facility include:

• Located in a vibrant urban center in the Tokyo metropolitan region – with Kashiwa serving as a booming biotech hub
• Japan’s first IDMO Smart Factory expects to employ 350 people
• Entire Smart Factory will integrate and optimize to eliminate downstream bottlenecks
• Has the potential to advance the development and approval of CAR-T therapeutics in Japan
• Once online, Cellares anticipates a seamless, rapid, software-enabled process for technical transfers between its facilities in other regions
• Cellares noted Mitsui Fudosan’s robust network in Japan’s life sciences industry, which was instrumental in enabling this collaboration
• Marks Cellares’ commitment to expanding its footprint in Japan, paving the way for further collaborations and innovations

‘Part of a broader strategy’

“Cellares’ new facility in Kashiwa City will enable our pharma clients to supply Japan from Japan,” said Fabian Gerlinghaus, CEO and co-founder of Cellares. “Manufacturing cell therapies locally simplifies cold chain logistics, accelerates vein-to-vein time and reduces cost.”

“For cancer patients in Japan, the establishment of this facility provides access to cutting-edge therapies that can make a critical difference in their fight against diseases,” said Dr. Toshihiko Doi, the chairperson of the Kashiwa-no-ha Life Sciences Committee. “It marks a significant step toward eliminating the drug delivery lag time that has been a challenge for rare diseases and oncology treatments.”

The announcement continues a string of notable partnerships and developments for Cellares, such as earning a first-of-its-kind designation last month by the U.S. Food and Drug Administration and more.

Gerlinghaus said, “Our Japanese IDMO Smart Factory is part of a broader strategy to be a global manufacturing partner for our clients and meet the total patient demand for cell therapies around the world.”