Hitachi Chemical Advanced Therapeutics Solutions Completes Technology Transfer to Enable Manufacturing of MaxCyte’s CARMA™ Cell Therapy for Clinical Use
PCT Team | January 29, 2019
Allendale, NJ, United States, January 29, 2019 - Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) announced it has successfully completed the technology transfer and implementation of the manufacturing process and commenced manufacturing services for dosing of patients in MaxCyte, Inc.’s Phase I dose-escalation clinical trial of MCY-M11 in the United States.
MaxCyte MCY-M11, its first autologous CARMA™ cell therapy drug candidate, is being evaluated in mesothelin-expressing solid tumors. The company’s clinical-stage CARMA program is focused on messenger RNA (mRNA)-based chimeric antigen receptors (CARs). Dosing of the first cohort in the Phase I study of intraperitoneal MCY-M11 therapy for women with platinum resistant cancer of the ovary or primary peritoneum, or individuals with peritoneal mesothelioma with recurrence after prior chemotherapy, is presently underway.
HCATS is a US subsidiary of Hitachi Chemical Co. Ltd. that engages in contract manufacturing and development of cell-based cell and gene therapy products through the PCT Global Service Platform.
“We would like to congratulate MaxCyte for launching its Phase I clinical trial and thank them for putting their trust in our company,” said Robert A. Preti, PhD, CEO and President of HCATS and General Manager of the Hitachi Chemical Regenerative Medicine Business Sector. “By providing the full range of PCT development and manufacturing services, we have contributed to the MaxCyte’s program’s initial clinical advancement into an area of significant unmet need.”
The MaxCyte/HCATS relationship began with a Strategic Manufacturing Assessment (SMA), a PCT consulting service, before moving to a manufacturing development project and then a rapid technology transfer and implementation in manufacturing. HCATS leveraged its 19+ years’ expertise and customer-centric approach to global service delivery to successfully accomplish the MCY-M11 technology transfer in less than five months to help meet MaxCyte’s timeline requirements for the Phase I start for its CARMA™ product, utilizing a streamlined one day manufacturing process.
HCATS is utilizing the proprietary MaxCyte GT® Scalable Transfection System to perform MaxCyte’s manufacturing process at the HCATS' Allendale, NJ facility. It is designed to provide scalability and establishes regulatory documentation to overcome the existing obstacles of cell therapy and enables the development and clinical manufacturing of next-generation cell and gene therapies with enhanced biological activity.
Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS, formerly PCT Cell Therapy Services, LLC), is a wholly owned subsidiary of Hitachi Chemical Company, Ltd. (Hitachi Chemical) representing Hitachi Chemical’s Regenerative Medicine Business Sector in the United States. HCATS leverages nearly two decades of experience exclusively focused on the cell therapy industry. It provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. Facilities to deliver these services under a global harmonized service platform have been established in Japan (Yokohama City, Kanagawa Prefecture), and in the United States (New Jersey and California), with an expansion to add commercial manufacturing capabilities and capacity underway in New Jersey. For more information about these services, please visit www.pctcelltherapy.com
MaxCyte is a global cell-based medicines and life sciences company applying its proprietary cell engineering technology platform to deliver the advances of cell-based medicine to patients with high unmet medical needs in a broad range of conditions. MaxCyte is developing novel CARMA therapies for its own pipeline. CARMA is MaxCyte’s mRNA-based proprietary therapeutic platform for rapid autologous cell therapy for the treatment of solid cancers. In addition, through its core business, MaxCyte leverages its Flow Electroporation® Technology to enable its biopharmaceutical industry partners to advance the development of innovative, cutting-edge medicines, particularly in cell therapy, including the use of gene editing tools in the treatment of inherited genetic diseases and immuno-oncology approaches to treating cancer. MaxCyte has placed its cutting-edge flow electroporation instruments worldwide, with all of the top ten global biopharmaceutical companies, has more than 70 partnered programme licenses in cell therapy including more than 35 licensed for clinical use. With its robust delivery technology platform, MaxCyte helps its partners to unlock the full potential of their products. For more information, visit www.maxcyte.com.