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.

Syner-G’s expert team effectively managed and supported process validation and comparability studies, ensuring the consistency and reliability of the manufacturing process. They developed comprehensive analytical qualification protocols and reports that identified key parameters for method validation. The team also conducted thorough process and equipment risk assessments to enhance operational performance and ensure regulatory compliance. Over 180 critical documents were reviewed and managed to confirm GMP readiness. The project also included the successful completion of Environmental Monitoring (EM) and Aseptic Operator Qualifications (AOQ) and Aseptic Process Simulation (APS) programs, with strategic execution of activities to support GMP batching. In the final phase, the team completed three consecutive batches in the GMP suite, including one GMP run, demonstrating robustness of the process and its readiness for scale-up.