PL BioScience Secures Certification from Japan's PMDA

PL BioScience GmbH has achieved a significant milestone by obtaining a Material Qualification Certificate from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its ELAREM™ Ultimate-FD PLUS (GMP Grade) cell culture media. This certification marks the first regulatory approval for ELAREM™ in Japan, a critical step towards facilitating clinical applications in the country.

ELAREM™ Ultimate-FD PLUS, a gamma-irradiated Human Platelet Lysate (HPL) developed by the German company, ensures viral inactivation and is the only product of its kind with a global patent. This recognition by the PMDA enhances the product's credibility, potentially accelerating its adoption among Japanese sponsors and Contract Development and Manufacturing Organizations (CDMOs), while paving the way for expansion in Asia.

With this certification, PL BioScience supports regenerative medicine developers in Japan, enabling faster and safer development of investigational products. The GMP-grade certification aids developers in reducing risks and streamlining processes, essential for the consistency and scalability of cell and regenerative medicine programs.