The Japanese company Reprocell has closed an investment in Histocell that will strengthen the Spanish company's offering in services based on clinical application of induced pluripotent stem cells (iPSCs). Based in the Bizkaia Science and Technology Park in Bilbao, Histocell is a CDMO (contract development and manufacturing organisation) with a manufacturing facility for advanced therapy medicinal products (ATMP) and it also offers GMP (good manufacturing practice) grade manufacturing services for cell therapy products. 

Authorised by the Spanish Agency for Medicines and Medical Devices (AEMPS), Histocell is also developing its own clinical projects based on adipose-derived mesenchymal stem cells (AMSC) for multiple indications. Reprocell's investment will strengthen the strategic relationship between the two companies and broaden the Japanese company's offering and business expansion.

Strict standards
Reprocell produces iPSCs that are suitable for therapeutic use, and which meet the strict standards set by regulatory agencies in the US (FDA), Europe (EMA) and Japan (PMDA). These cells (StemRNA™ Clinical iPSC Seed Clones) have already been evaluated, approved and used by numerous biopharmaceutical customers.

In the words of Reprocell CEO Chikafumi Yokoyama, “Through this investment, we are excited to build a closer relationship with Histocell and have access to their proven expertise in GMP-grade manufacturing.”

Histocell's CEO, Julio Font, responded, “Reprocell's investment in Histocell reinforces our commitment to developing high standards and GMP manufacturing of advanced therapy medicines.  We are delighted to have Reprocell as a strategic partner in the area of iPSCs.”

Slow and costly process
As Reprocell explained, the process of developing cell therapies is slow and costly, requiring strict compliance with regulatory and manufacturing standards which are different for each national regulatory agency. Through its clinical network, the Japanese company procures the tissue needed for its therapeutic programmes and performs the mandatory viral profile and donor screening tests to meet the requirements of these agencies. 

Histocell develops cell therapy products and medical devices for regenerative medicine. Among its proprietary projects, it offers solutions to improve wound healing processes and regenerate skin tissues, AMSC-based cell therapy programmes for bone regeneration and a cellular therapy product for acute spinal cord injuries and lung diseases.

^{Photo: Histocell}