MONT-SAINT-GUIBERT, Belgium--(BUSINESS WIRE)--Cellistic®, a pioneer in iPSC-based off-the-shelf cell therapy development and manufacturing, announces the successful audit and GMP certification of its first-of-its kind facility dedicated to manufacturing therapies based on induced pluripotent stem cells (iPSCs). This achievement signifies Cellistic’s quality and regulatory readiness, which is now certified by the Belgian Federal Agency for Medicines and Health Products (FAMHP), operating under European Medicines Agency (EMA) guidelines.
With close to 15 years of cell therapy GMP manufacturing experience, Cellistic has retrofitted its facility into a state-of-the-art centre exclusively focused on iPSC-based allogeneic cell therapy, recently receiving Belgian regulatory approval after a thorough audit. The facility now offers segregated areas for open and closed cell manufacturing, fill-and-finish cryopreservation, packaging as well as QC and warehousing capabilities, creating a comprehensive, one-stop-shop environment designed to meet the exacting standards of iPSC-based allogeneic cell therapy production.
This GMP milestone also includes the implementation of iPSC-based processes in stirred tank bioreactors as part of Cellistic’s Echo platform. The use of bioreactors allows Cellistic to scale up cell therapy manufacturing in a cost-effective manner, thereby reducing the overall product cost significantly.
With a significant regulatory track record of 7 GMP inspections and over 400 autologous and allogeneic cell therapy batches produced, the Cellistic team embodies the know-how and experience required for safe, consistent, and scalable allogeneic cell therapy manufacturing.
“Cellistic’s mission has always been to pave the way to accessible cell therapies, making treatment more available to patients,” says Gustavo Mahler PhD, CEO of Cellistic. “Our deep expertise in iPSC reprogramming, gene editing, and differentiation, combined with this expanded manufacturing capability, makes Cellistic a trusted partner for innovators looking to bring cell therapies to the clinic. We’re excited to provide scalable, GMP-compliant solutions that support our clients at every stage, from initial development through to commercialization.”
Following GMP certification, the facility promptly began manufacturing activities to support existing Cellistic customers.
About Cellistic™
Cellistic specializes in process development and manufacture of immune cell therapies based on human induced pluripotent stem cell (iPSC) technology using their Pulse™ and Echo™ Platform. Its focus and expertise in iPSC reprogramming, gene editing using its proprietary STAR-CRISPR™technology and differentiation development, positions the company to be the partner of choice for innovative cell therapy developers to advance into clinic. Leveraging more than a decade of scientific and technical knowledge and experience, Cellistic possesses unique capabilities for the design and optimization of proprietary manufacturing platforms for iPSC- based cell therapies.
For more information, visit www.cellistic.com.
Contacts
Cellistic
partnering@cellistic.com
