The Thermo Fisher Scientific St. Louis facility offers full mammalian cell process development including late stage characterization and process validation to support clinical (Phase I-III) to commercial manufacturing.
Specialized Capabilities include:
Quantity: protein A/G HPLC, ELISA titer assay, A280
Amino Acid Analysis by UPLC
Capillary electrophoresis (CE-SDS, cIEF, CE-LIF)
Extinction Coefficient determination
DOE for method development and method validation
N-Glycan profiling by fluorescence-labeling and normal phase HPLC or CE
Protein conformation characterization using capillary DSC
Sialic acid content and NANA/NAGA ratio measurement
High throughput CE-SDS and glycan profiling with microfluidic instrument
Monosaccharide Analysis
Charged Aerosol Detector (CAD) used to test Polysorbate, Anti-foam, Pluronic
This site features a strong regulatory inspection history from all major regulatory agencies.
Learn more about the specific equipment and capabilities at this site by downloading our Site Fact Sheet.
Alachua, Florida Our Alachua facility incorporates equipment and design concepts that set the standard for process and analytical development for early clinical trials, and ultimately commercial scale CDMO capabilities for these advanced therapies. We develop analytics and processes for the major viral gene transfer vector systems: AAV, Adenoviral, Herpesviral, Lentiviral, and Retroviral, using a range… Read More
Bend, Oregon Our Bend facility is our site network’s Center of Excellence for Solubility. The Bend site campus is divided into two main buildings; one devoted to business services and manufacturing, the other to warehousing, receiving, shipping, R&D and QC Laboratory services. The manufacturing facility comprises two separate areas including formulation and process development as well… Read More
Cambridge, Massachusetts Our Cambridge facility houses state-of-the-art equipment in cleanroom suites specially designed to accommodate a broad-range of viral vector manufacturing process technologies. It boasts multiple drug substance suites able to support large-scale adherent and stirred tank production, an automated fill/finish system leveraging isolator technology, quality control laboratories, and process development space. The facility is… Read More
Cincinnati, Ohio With over 750 employees, our Thermo Fisher Scientific site in Cincinnati offers controlled and sustained release solid oral dosage forms, osmotic release dosage forms (laser drilling), liquid fill hard capsules, controlled substances manufacturing, abuse deterrent dosage forms. Cincinnati has a high potency API (HPAPI) potency capacity of Cat 2, with select suites for… Read More
Our Florence, SC (East) site is a flexible drug substance manufacturing site offering highly potent compound handling, process development and scale-up. Large-scale and mid-scale API production. The site also has capabilities in solid state chemistry, spray drying, and micronization. The facility is fully compliant with all applicable regulations and meets the most stringent production, quality,… Read More
Florence, South Carolina (West) Florence (West) is one of two small molecule API sites we have in Florence, SC. Florence (West) specializes in process development and chemical production of intermediates and APIs for toxicology, pre-clinical and clinical supply under both non-cGMP and cGMP conditions, and has a potency capacity of Cat 3a. Specific offerings include: Production… Read More
Greenville, North Carolina Our Greenville, NC site facility is a large, multipurpose pharmaceutical manufacturing and packaging campus. This site provides both solid dose form manufacturing/packaging and sterile dose manufacturing, filling and lyophilization of both biopharmaceuticals and small molecules. Greenville’s clinical and commercial manufacturing services include: Capabilities: Solids Sterile liquids Sterile lyophilization Controlled drugs Secondary packaging… Read More
Greenville, South Carolina Greenville, SC is experienced at process development and chemical production of intermediates and APIs for clinical and commercial supply under cGMP and ISO conditions. This 23 acre site was built in 1998, and is fully cGMP compliant. Specialized offerings include: Production scales ranging from 2 kg to metric tons cGMP manufacturing of… Read More
High Point, North Carolina High Point, NC is a commercial manufacturing and development site focusing on gelatin based drug delivery dosage forms (softgels). High Point is a Softgel Center of Excellence since 1996, offering extensive development and commercial scale capabilities for a variety of softgel technologies. Specialized capabilities include: Manufacturing with use of specific proprietary… Read More
Lexington, Massachusetts Our Lexington facility houses state-of-the-art equipment in cleanroom suites specially designed to accommodate a broad-range of viral vector manufacturing process technologies. It boasts multiple drug substance suites able to support large-scale adherent and stirred tank production, an automated fill/finish system leveraging isolator technology, quality control laboratories, and process development space. The facility is… Read More
Manatí, Puerto Rico, U.S.A. Our Manatí facility specializes in the medium to high volume commercial manufacture of solid dosage forms including tablets, capsules, bulk granules, and powders packaged in bottles. The facility’s environmental controls and ventilation systems facilitate explosion-proof manufacturing, including solvent coating of tablets and high-potent compounds. This flexible facility also has a low-humidity manufacturing… Read More
Plainville, Massachusetts Our newest site location in Plainville, MA is a 290,000 square-foot facility with room for expansion and will be operational in 2022.
Princeton, New Jersey Princeton, NJ is part of our world-class bioprocess and analytical development network, focused on safe and efficient delivery of robust biologics manufacturing processes that maximize client value and drive a healthier world. Our Princeton site features bioprocess, analytical and formulation development laboratories with significant development expertise, and has helped develop processes for… Read More
Toronto, Ontario Our Toronto facility covers all phases of drug product development from early-phase formulation development to clinical trial material to commercial supply in the same plant using scalable equipment for non-GMP and GMP Work. Our experts at the Toronto facility are ready to address your needs for highly potent, low potent, complex formulations, pediatric… Read More
The Thermo Fisher Scientific St. Louis facility offers full mammalian cell process development including late stage characterization and process validation to support clinical (Phase I-III) to commercial manufacturing.
Specialized Capabilities include:
