White Paper: CDMO Service

Excellos’ development and manufacturing teams have successfully executed Current Good Manufacturing Practice (cGMP) production of a retrovirally transduced cell therapy derived from primary umbilical cord tissue, supporting Phase 1, Phase 2, and ongoing Phase 3 clinical trials. The production process involves three key stages.

First, umbilical cord tissue is collected, followed by primary cell isolation and characterization using Fluorescent Activated Cell Sorting (FACS). These cells undergo ex vivo expansion in tissue culture flasks, lentiviral transduction, and are cryopreserved. In the second stage, thawed cells are expanded at a larger scale using hollow-fiber perfusion bioreactors and cryopreserved to establish working cell banks (WBCs) for future clinical manufacturing. The third stage involves post-thaw processing, seeding into bioreactors, and large-scale expansion to produce final therapeutic products for clinical use.

All operations are conducted under cGMP conditions in ISO 7 cleanrooms and include environmental monitoring, qualified materials management, vendor qualification, QA/QC oversight, comprehensive staff training, and complete batch record documentation. Learn more about the process by downloading the white paper below.