News | July 28, 2022

RepliCel's Manufacturing Inspected By Japan's PMDA

After over a year of pandemic-related delays, representatives of Japan's PMDA, attended at the Company's contract manufacturing facility, Innovacell, to review the manufacturing of RepliCel's NBDS cell therapy products

RepliCel Life Sciences Inc. ("RepliCel" or the "Company"), a company developing novel, next-generation injection technologies as well as regenerative medicine products in aesthetics and orthopedics, is pleased to announce the completion, last week, of an inspection of RepliCel's NBDS cell therapy manufacturing at its Austrian contract manufacturing facility owned and operated by Innovacell KK (Tokyo, Japan).

The inspection was performed, in accordance with the specifications set out in Japan's Act for the Safety of Regenerative Medicine (ASRM), by specialists of the Japanese Pharmaceutical and Medical Devices Agency (PMDA) at the request of Japan's Ministry of Health, Labour & Welfare (MHLW) upon application by RepliCel for certification of its NBDS cell therapy manufacturing.

MHLW manufacturing certification, obtained after successful completion and passing of an inspection by PMDA specialists (as occurred last week), is a precursor to the ASRM-governed clinical studies RepliCel is preparing to conduct in Japan of its two NBDS cell therapies, RCT-01 and RCS-01 for the treatment of chronic tendinopathy and the rejuvenation of aging/sun-damaged skin.

Such certification of RepliCel's manufacturing would be the first of its kind. Despite having certified facilities in Korea, China and Taiwan, no cell therapy manufacturing facility has yet received such a certification outside of Asia.

"This is another milestone in RepliCel's First-in-Japan program," states RepliCel's President & CEO, R. Lee Buckler. "Our RCH-01 cell therapy was one of the first to be launched into clinical study under Japan's ASRM pathway. It was also one of the first corporate-sponsored cell therapy, and the first cell therapy developed outside of Asia, to be the subject of an ASRM clinical study."

"As we prepare for our next-phase clinical studies in Japan," Buckler continues, "we are building a strong network of support and accomplishments. Our business, clinical and regulatory teams are doing everything needed to ready our programs for clinical evaluation and commercialization in Japan."

RepliCel's team in Japan includes:

  • regenerative medicine industry specialists, CJ PARTNERS;
  • clinical research organization, Accerise;
  • globally prominent key opinion leaders engaged as clinical advisors in dermatology and orthopedics in Japan; and
  • the Company's Senior Strategic Advisor for Japan, Kunihiko Suzuki, one of the leading business pioneers in the Japanese cell therapy industry. Mr. Suzuki has recently been appointed by Japan's Forum for Innovative Regenerative Medicine (FIRM, Japan's cell/gene therapy industry organization), as Chair of FIRM's Specific Process Cells Committee intended to bring increased rigor and industry oversight to the development, manufacture, and commercialization of cell therapies, such as RepliCel's RCS-01, being clinical tested and commercialized in Japan under country's ASRM pathway.

Source: RepliCel Life Sciences Inc.