Shonan iPark to Launch Rental-type “Cell Processing Center” Compliant with GMP/GCTP Standards, in November 2025
Press Release
May 20, 2025
iPark Institute Co., Ltd.
Minaris Advanced Therapies
Hitachi Global Life Solutions, Inc.
Shonan iPark to Launch Rental-type “Cell Processing Center” Compliant with GMP/GCTP Standards, in November 2025
● Rental cleanrooms for startups and enterprises to manufacture cell therapy investigational products.
● Minaris Advanced Therapies to provide quality assurance services, with cleanroom installation by Hitachi Global Life Solutions.
● Prospective user Alloy Therapeutics, Inc. provides expertise in designing the facility and building an on-demand manufacturing and quality control system.
iPark Institute Co., Ltd.(hereinafter “iPark Institute”), Minaris Advanced Therapies, LLC. (hereinafter “MAT”), and Hitachi Global Life Solutions, Inc. (hereinafter “Hitachi GLS”) announced today the construction of a new rental Cell Processing Center (CPC) within the Shonan Health Innovation Park (commonly known as “Shonan iPark”), which will comply with GMP¹ and GCTP² standards. The facility is scheduled to begin operations in November 2025.
MAT will oversee facility management and provide quality assurance services, while Hitachi GLS will deliver the clean room units, which are modular CPC that are easy to install initially and can be easily expanded. Alloy Therapeutics, a prospective user of the facility, has contributed its expertise in the design of the facility and in building an on-demand service model for manufacturing and quality management.
¹GMP: Good Manufacturing Practice – standards for the quality control of pharmaceuticals and quasi-drugs
²GCTP: Ministerial ordinance concerning standards for manufacturing and quality control of regenerative medical products
Background
In the development of cell therapy products, a smooth transition from preclinical research to early-stage manufacturing is critical, and various manufacturing strategies are adopted depending on the startup or enterprise. However, establishing and operating an in-house CPC that complies with GMP/GCTP standards requires significant financial investment and specialized personnel. When outsourcing to a CDMO from the early stages, the associated costs and time requirements may hinder development speed and fundraising efforts. In light of these challenges, on-demand rental CPCs have emerged as a third manufacturing strategy, with a track record of over a decade in countries such as the UK and the USA. Through a partnership with MAT, iPark will also be able to offer seamless strategic options for later-stage clinical and commercial-scale manufacturing. Several companies and startups engaged in cell therapy R&D are already located at iPark. The new facility will provide new options for manufacturing strategies not only for the tenants, but also for companies working on cell-based medicines and regenerative medicine products across Asia.
The new facility will not only support these tenants, but also provide a new option for manufacturing strategies to companies across Asia involved in cell and regenerative medicine product development.
Overview of the Cell Processing Center
For Inquiries Regarding Facility Use:
E-mail: Shonan-Health-Innovation-Park@shonan-ipark.com
Regarding the launch of this new facility, Toshio Fujimoto, President and CEO of iPark Institute, commented: “We are very pleased to be able to offer this new facility to startups and companies developing cell therapy drugs. The new GMP-grade, rental-type Cell Processing Center will facilitate the seamless transition of technology from research to manufacturing for startups and companies developing cell-based therapeutics. Furthermore, the facility will allow for flexible investment decisions as research progresses, lowering barriers to entry, stimulating research, and contributing significantly to the advancement of novel therapeutic products.”
For Media Inquiries:
iPark Institute Co., Ltd.
Communications: Sugita, Tsukahara
Mail : iPi.PR@shonan-ipark.com