REPROCELL has been producing clinically relevant human induced pluripotent stem cells (hiPSCs) by controlling the process of donor recruitment to seed stock hiPSC and encompassing donor eligibility with different geographical regulatory agencies. Raw materials undergo strict selection and a proprietary method of footprint free RNA reprogramming is used. REPROCELL has now extended this offering by acquiring a Cytocentric Xvivo system model 2, from BioSpherix, which is a closed GMP cell culturing system, to manufacture hiPSC and hMSC that are suitable for therapeutic use.
In contrast to conventional clean rooms that utilize cell culturing and processing in open incubators and open hoods, the Xvivo System consists of modular sets of closed incubators and closed hoods, integrated together as co-chambers and sub-chambers. The enclosed nature of the system allows each chamber to undergo individual environmental control and monitoring. These controls allow greater consistency of the culture environment and reduced risk of contamination, resulting in a superior product and a faster turn-around time.
The GMP Biomanufacturing Facility at REPROCELL USA was inaugurated by Mr. Kevin Anderson, Secretary, Department of Commerce, State of Maryland on May 15, 2024. This enables REPROCELL to generate off-the-shelf GMP grade hiPSC and hMSC for internal use as well as to satisfy the needs of therapeutic, pharmaceutical and biotechnology companies at a competitive price. "This GMP Manufacturing Facility makes REPROCELL a leader in providing hiPSC from donor to GMP grade hiPSC MCB utilizing footprint free RNA reprogramming technology," said Dr. Chikafumi Yokoyama, CEO of the global REPROCELL group. "This GMP facility provides a unique resource to all the cell therapy companies in Maryland and rest of the USA," said Rama Modali, CEO of REPROCELL USA.