- REPROCELL will expand its GMP contract manufacturing capabilities in Maryland through a grant from the Maryland Stem Cell Research Fund (MSCRF).
- The expansion will include a clean room for large-scale production of hiPSC-derived cell therapy products, including iMSC, gene editing, and differentiation services.
REPROCELL is set to enhance its contract development and manufacturing organisation (CDMO) capabilities with the support of a grant from the Maryland Stem Cell Research Fund (MSCRF). The grant will fund the creation of a clean room equipped for large-scale GMP-grade manufacturing of cell therapy products, enabling the company to consolidate multiple GMP technologies under a single roof.
The initiative follows a 2024 MSCRF-funded project that enhanced REPROCELL’s Cytocentric® Xvivo System Model 2, a closed GMP system for producing master cell banks. The new CDMO capabilities will allow REPROCELL to generate working cell banks, perform GMP-grade differentiation, offer gene editing services, and produce large-scale mesenchymal stem cells (iMSC) derived from hiPSCs.
REPROCELL’s hiPSCs are derived from healthy, ethically consented donors and screened to meet regulatory standards from the FDA, EMA, and PMDA. Further viral testing ensures compliance with international regulatory requirements for clinical use.
The MSCRF grant is a 1:1 match, meaning REPROCELL will contribute an equal amount of funding to the project. Ruchika Nijhara, Ph.D., executive director of MSCRF, said: “We are pleased to support REPROCELL USA as they expand their GMP manufacturing capabilities in Maryland. REPROCELL is strengthening Maryland’s leadership in regenerative medicine by building essential manufacturing infrastructure to bring stem cell-based therapies from bench to bedside.”
The expanded facility positions REPROCELL to provide end-to-end contract manufacturing solutions for regenerative medicine, supporting the development and delivery of cell therapy products on a larger scale.
