During a two-day STSM Begoña Aran (Barcelona Stem Cell Bank Coordinator) was hosted by CITHERA, where she gained direct insight into the organisation and operation of a GMP-compliant iPSC facility. The layout of the Grade B and Grade C cleanrooms was observed, together with the strict separation maintained between research and GMP activities. Dedicated areas for cryopreservation, cell culture, flow cytometry and PCR were also examined.
Through discussions with the technical staff, detailed information was obtained about the complete workflow used for the generation of GMP-grade iPSC lines. Although direct access to the data management system could not be granted because of confidentiality restrictions, the key principles of traceability and documentation applied in a GMP environment were explained and discussed.
Overall, the objectives outlined in the STSM working plan were fully achieved, and valuable practical knowledge of GMP workflows, regulatory requirements and documentation standards for clinical-grade iPSC production was acquired. The knowledge gained is expected to enhance Begoña Aran’s contributions to several HAPLO-iPS Working Groups, particularly WG2, WG3, WG4 and WG7.
Despite the confidentiality restrictions, meaningful exposure to GMP operations was provided, and opportunities for future collaboration with CITHERA were identified. Begoña Aran’s professional development was significantly strengthened by the experience, while greater alignment of methodologies across European iPSC infrastructures is expected to be supported.