A Research Cell Bank (RCB) is an early-stage, non-GMP collection of cryopreserved cells derived from a clonal cell population or primary cell source, used to support early research, feasibility studies, and process development activities prior to the establishment of a GMP-compliant Master Cell Bank (MCB). Although not subject to the full characterization and qualification requirements of a Master Cell Bank, the RCB serves as the foundational starting material from which the cell banking hierarchy — RCB → MCB → Working Cell Bank (WCB) — is built, and its traceability and documentation are critical for subsequent regulatory submissions.
