Material Qualification Certificate – PMDA

PL BioScience announces Material Qualification Certificate from Japan’s PMDA

PL BioScience announces Material Qualification Certificate for ELAREM™ Ultimate-FD PLUS from Japan’s PMDA

PL BioScience announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has issued a Material Qualification Certificate for ELAREM™ Ultimate-FD PLUS (GMP Grade), the company’s processed cell culture media based on human platelets designed to support the efficient and safe in vitro expansion of primary cells and cell lines.

“The PMDA material qualification is an important step for PL BioScience as it allows us to support developers in Japan who are advancing regenerative medicine and other clinical programs that require certainty in raw material quality and safety compliance,” said Dr. Hatim Hemeda, CEO, PL BioScience. “We believe ELAREM™ can help teams move faster with confidence as they design and manufacture investigational products.”

“By having a GMP-grade, platelet-derived cell culture media formally qualified for clinical use in Japan, developers can de-risk their CMC packages, streamline supplier qualification work, and potentially shorten the path from process development to first-in-human production,” said Jungsoo Park, VP of Marketing and Sales, PL BioScience. “Especially in cell and regenerative medicine programs where media choice can materially affect consistency and scalability.”

Read the complete Press Release here.