The Xvivo GMP system has a significantly lower contamination risk from room air and personnel compared to open clean room suites. It has a proven track record of producing a GMP-compliant environment for manufacturing iPSC and iMSC master cell banks (MCBs), suitable for therapeutic development and the production of other differentiated cell lineages. The system also integrates microscopes, centrifuges, and cryopreservation instruments. By minimizing contamination risks, it enhances cell product quality and accelerates turnaround times.

The Biospherix Cytocentric Xvivo system provides a GMP-grade cell production environment that meets Class 100 (ISO 5) standards through more than 120 HEPA-filtered air changes per hour. Its surrounding area is curtained and filtered to meet Class 10,000 (ISO 7). The system complies with the FDA Section 503B regulations, as well as ISO 14644 and USP 797 standards. Additionally, its environmental control and monitoring software follows 21 CFR Part 11, ensuring secure operator tracking and record management.

Our donors are recruited in the US and the process follows FDA 21 CFR 1271, EMA COMMISSION DIRECTIVE 2006/17/EC and PMDA MHLW Notification No.375, along with an IRB approved informed consent form.

Pathogen testing is performed at CLIA and EMA certified laboratories and we follow guidelines for USP29 <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products and EMA COMMISSION DIRECTIVE 2004/23/EC and PMDA MHLW Notification No.375 for raw materials.

REPROCELLʼs StemRNA™ Clinical iPSCs are generated utilizing an in-house developed proprietary, footprint-free RNA reprogramming technology, eliminating the risk associated with retention of reprogramming vectors, and drastically enhancing the safety profile for clinical applications.