#USA #Beltsville #GMP #iPSC #REPROCELL

REPROCELL Introduces GMP-Compliant Master Cell Bank Manufacturing for iPSCs

REPROCELL, a prominent name in the biotechnology industry, has officially launched its Good Manufacturing Practice (GMP) compliant Master Cell Bank (MCB) service for clinical usage of human induced pluripotent stem cells (iPSCs). This significant development aims to enhance the efficiency and regulatory compliance of cell therapy production, addressing critical needs within the field.

Located in Beltsville, Maryland, REPROCELL's new service provides an integrated workflow for clinical-grade iPSC manufacturing. This encompasses everything from the creation of StemRNA™ clinical iPSC seeds to StemEdit genetic editing, ultimately producing GMP Master Cell Banks that adhere to FDA regulations. By unifying these integral processes, REPROCELL aids cell therapy developers in expediting their Investigational New Drug (IND) applications, thereby minimizing manufacturing and regulatory uncertainties.

One of the primary features of this new service is the StemRNA Clinical iPSC clone, LLF-34-F3. This clone, derived from healthy American donor material, is compliant with regulatory standards including the FDA, the European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Furthermore, it is supported by an active Drug Master File (DMF) filed with the FDA, illustrating its credibility and readiness for clinical applications. The process to establish this GMP iPSC Master Cell Bank incorporates closed-system methodologies that also meet FDA's stringent requirements, ensuring that the material is clinically validated and ready for commercial use.

In addition, for sponsors requiring European compliance, REPROCELL has partnered with Histocell for MCB/WCB manufacturing, which is GMP certified and authorized by the AEMPS, being supervised by the EMA. This strategic partnership expands REPROCELL's capabilities to meet diverse regulatory needs across different regions.

Key Capabilities of Clinical iPSC

Among the standout features of the new iPSC services are:

• - Donor Eligibility and Consent: The procurement process for donor material meets FDA, EMA, and PMDA regulations, ensuring informed consent for therapeutic use.
• - Genetic Engineering: Utilization of proprietary RNA reprogramming technology allows for the generation of clinical-grade iPSC seed clones that align with regulatory standards.
• - Safety Assessment: Comprehensive genetic integrity assessment and oncogenic risk evaluation are conducted through whole genome sequencing (WGS) of the StemRNA clinical seed clones.
• - Genetic Editing: The StemEdit genetic editing service is designed for high efficiency with minimized off-target activity and expected lower immunogenicity.
• - GMP Compliance: The production of MCBs is strictly according to FDA or EMA/PMDA regulations, reinforcing REPROCELL’s commitment to high-quality outputs.

About the StemRNA™ Clinical iPSC Seed Clone

StemRNA™ Clinical iPSC Seed Clone – LLF-34-F3 is derived from a healthy female donor who has provided full consent for commercial and therapeutic use. The clone is homozygous for the HLA-A and HLA-DPA1 loci, greatly enhancing its potential in allogeneic applications. This clone is compliant with FDA, EMA, and PMDA standards and is bolstered by an active DMF, ensuring traceable and clinically ready raw materials.

REPROCELL also provides an array of StemRNA™ Clinical iPSC seed clones from various donor profiles, catering to a broad spectrum of research and therapeutic needs.

Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc., expressed excitement about the completion of the integrated workflow for iPSCs that encompasses donor selection, iPSC seed manufacturing, genetic editing with StemEdit, and cell storage under GMP conditions. This unified framework, he noted, streamlines pathway development for clinical programs. The integrated platform is designed to accelerate IND/CTA applications while preserving quality, traceability, and conformity to global regulatory norms.

REPROCELL’s Commitment

REPROCELL is devoted to offering comprehensive solutions in stem cell manufacturing, genetic editing, and GMP practices, beginning at discovery and extending through to clinical applications. By delivering clinical-grade iPSC generation (StemRNA™ Clinical iPSC), the StemEdit genetic editing service, and GMP storage solutions, REPROCELL serves academic and pharmaceutical organizations looking for reliable and regulation-ready starting materials.

This initiative received funding through a marketing grant (#2024-MSCRFCO-6418) from the Maryland Stem Cell Research Fund (MSCRF). For further information, visit www.reprocell.com.