San Diego, California, USA

The pharmaceutical services science and technology facility in San Diego, located at Wateridge Circle, is a 32,000-square-foot facility dedicated to advanced therapy CDMO R&D and translational services.

The R&D aspect focuses on developing next-generation cGMP platforms for plasmid DNA, viral vectors, and cell therapy, to be implemented in Thermo Fisher Scientific's advanced therapy CDMO network. The development and integration of advanced analytics to address emerging regulatory trends and the implementation of best practices in accordance with the latest global quality and standardization guidelines help ensure the excellence of cell therapy and viral vector CDMO services.

Translational services support advanced therapy drug developers in the early stages of development, facilitating lead identification and process establishment. These services are dedicated to producing molecular biology, viral vector, and cell therapy RUO materials using high-quality raw materials, established and scalable processes, and advanced analytical testing that is representative of cGMP workflows, enabling a quicker and easier transition to PD/cGMP manufacturing.

Specialized capabilities:

• Cell therapy services
• Viral vector packaging services
• Molecular biology services supporting cell therapy and viral vector development
• Analytical testing services

Note: Translational Services generate materials for research use only and are not intended for IND (Investigational New Drug)-enabling studies or diagnostic purposes.