Cellistic Achieves GMP Certification for iPSC-based Cell Therapies Manufacturing Facility

• Cellistic has achieved GMP certification for its Belgian facility, the first of its kind dedicated to iPSC-based therapies.

• The facility offers advanced manufacturing capabilities and supports scalable, cost-effective production of iPSC-based allogeneic cell therapies.

Cellistic, an innovator in iPSC-based off-the-shelf cell therapy development and manufacturing, has achieved GMP certification for its advanced facility in Belgium. The certification, granted by the Belgian Federal Agency for Medicines and Health Products (FAMHP) under EMA guidelines, reflects the facility’s compliance with stringent regulatory standards.

This milestone positions the facility as a specialised centre for allogeneic iPSC-based cell therapy production. Retrofitted to meet cutting-edge requirements, the facility now provides dedicated areas for open and closed cell manufacturing, cryopreservation, packaging, quality control, and warehousing. These capabilities offer a comprehensive solution for allogeneic cell therapy developers.

Key to the facility’s operations is the implementation of bioreactor technology through the Echo platform. The use of stirred tank bioreactors enables scalable manufacturing processes, significantly lowering production costs. With nearly 15 years of GMP manufacturing expertise and over 400 cell therapy batches produced, Cellistic is well-equipped to deliver safe, consistent, and scalable manufacturing solutions.

“Cellistic’s mission has always been to pave the way to accessible cell therapies, making treatment more available to patients,” commented Gustavo Mahler, PhD, CEO of Cellistic. “Our expanded manufacturing capability makes Cellistic a trusted partner for innovators looking to bring cell therapies to the clinic.”