From CDMO to In-House cGMP Manufacturing: Scaling Success in Cell Therapy Technology Transfer

A clinical-stage company developing innovative cell therapies for cancer and immune-mediated diseases partnered with Syner-G BioPharma Group to scale and transfer their manual manufacturing process from a Contract Development and Manufacturing Organization (CDMO) to a newly established Good Manufacturing Practice (GMP) suite at their existing facility. This critical transfer was pivotal in supporting the company’s growth, enhancing operational efficiency, and preparing for upcoming clinical and commercial milestones. The primary objective was to successfully scale and transition the manual manufacturing process to the internal GMP facility while ensuring operational readiness and full compliance with both EU and FDA regulatory standards.