Biologics development and manufacturing facility
The Thermo Fisher Scientific's St. Louis, MO biologics facility offers robust services for full mammalian cell process development, analytics, and end-to-end cGMP manufacturing services. The 96,875-square-foot multi-product facility features full life-cycle support from FIH to commercialization, extensive cell culture capacity in fed-batch, perfusion and n-1 perfusion production modes, and flexible downstream capacity for batch sizes of 100g – 20kg. Thermo Fisher’s advanced bioproduction technologies include single-use equipment with up to 5,000L scale.
The site is a Center of Excellence for single-use technology, driving innovations in bioreactor scales from 50L up to 5,000L, and offering our customers the flexibility to adapt their cell culture capacity to fit their drug across all phases of development and commercialization. The new 5kL Dynadrive bioreactor was co-created at the site in our Bioprocessing Collaboration Center (BCC), which brings together Thermo Fisher’s leadership in cGMP biologics manufacturing with its deep expertise in bioprocessing product development; this includes bioreactors, cell culture media, chromatography, and analytical tools, among others.
The site is a Center of Excellence for single-use technology, driving innovations in bioreactor scales from 50L up to 5,000L, and offering our customers the flexibility to adapt their cell culture capacity to fit their drug across all phases of development and commercialization. The new 5kL Dynadrive bioreactor was co-created at the site in our Bioprocessing Collaboration Center (BCC), which brings together Thermo Fisher’s leadership in cGMP biologics manufacturing with its deep expertise in bioprocessing product development; this includes bioreactors, cell culture media, chromatography, and analytical tools, among others.
St. Louis is also home to our Quick to Clinic for BiologicsTM platform-based early development solution which enables our customers to accelerate their molecule development timelines from preclinical to IND/IMPD in as little as 13 months.
Capabilities
- Center of Excellence in single-use technology
- In-house and partnered mammalian cell line development
- Upstream and downstream process development expertise
- Robust in-house analytics for QC, QA, and AFS
- Fed-batch, perfusion, and n-1 perfusion production modes
- Scale up and cGMP manufacturing for early and late clinical trials, PC/PV/PPQ, and commercialization
