REPROCELL Inc. decided to invest in Histocell S.L. to strengthen its clinical induced pluripotent stem cell (iPSC) service offerings.
Histocell is a CDMO based in Bilbao, Spain, with an authorized Advanced Therapy Medical Product (ATMP) manufacturing facility that offers GMP-grade manufacturing services for cell therapy products. Histocell also develops its own clinical pipelines based on adipose-derived mesenchymal stem cells (AMSC) for multiple target indications.
REPROCELL manufactures iPSCs that are suitable for therapeutic use and compliant with the key regulatory standards stipulated by the US FDA, European EMA, and Japanese PMDA. These Seed iPSCs (StemRNA™ Clinical iPSC Seed Clones) have been evaluated, approved, and employed by numerous biopharma clients to today.
This investment into Histocell will strengthen the strategic relationship between the companies and broaden REPROCELL’s offerings.
“Through this investment, we are excited to build a closer relationship with Histocell and to have access to Histocell’s proven expertise in GMP-grade manufacturing” said Chikafumi Yokoyama Ph.D., CEO of REPROCELL Inc.
“REPROCELL’s investment in Histocell reinforces our commitment in high standards development and GMP manufacturing of Advanced Therapies Medicinal Products. We are delighted to have REPROCELL as strategic partner in iPSCs Area” said Julio Font Ph.D., CEO of Histocell, S.L.
About REPROCELL’s iPSC generation suitable for therapeutic programs.
Developing cellular therapies is a time-consuming and costly process. It requires strict adherence to manufacturing and regulatory standards that are different for each national regulatory agency. REPROCELL manufactures GMP iPSC MCBs that are compliant with the regulatory standards and guidelines of the FDA, EMA, and PMDA.
Through our clinical network, we can procure the tissues needed for therapeutic programs and conduct the mandatory viral and donor profile screenings compliant with key regulatory agencies.
After deriving a primary fibroblast primary culture, we use our proprietary footprint-free RNA reprogramming technology to generate a clinical grade iPSC seed stock (StemRNA™ Clinical iPSC Seed Clones).
Under strict quality control measures, these Seed Clones are expanded in a GMP-grade environment to manufacture a master cell bank. REPROCELL’s GMP iPSCs are suitable for commercial and therapeutic programs, subject to a simple one-time commercial and therapeutic license fee without limitation in any therapeutic fields.
For more information: https://www.reprocell.com/gmp-ipsc-master-cell-bank.