Greenfield Gene Therapy Manufacturing Facility

Salas O’Brien provided comprehensive engineering services for Pfizer’s new gene therapy manufacturing facility. Our team served as subject matter experts in drug product manufacturing, supporting the commissioning and validation of aseptic filling equipment. The project scope included buffer preparations, two cell culture suites, two purification suites, and a drug product suite. We addressed an existing filling volume accuracy issue by conducting structured experiments and data analysis, which led Pfizer to file multiple patent applications on the solution we developed. Our expertise contributed to the development of a new facility that will manufacture vital medications, and we significantly improved the current filling process to prevent quality control issues.