Thermo Scientific Contract Manufacturing

Thermo Fisher Scientific's main OEM contract manufacturing facilities are located in Middletown, VA, East Providence, RI, Fremont, CA and Austin, TX. Combined, the facilities have been in operation for over 30 years and have expertise in contract manufacturing reagents, standards, controls, calibrators and consumables for Clinical Chemistry, Immunochemistry, Hematology, Coagulation and Serology. Our facilities are regulated and compliant with ISO 13485:2003, cGMP, Canadian Medical Device Regulations, 98/79 EC In-Vitro Diagnostics Directive and the Drug Enforcement Agency. Our Thermo Scientific products include clinical chemistry reagents, TDM’s and DAU’s, rapid diagnostic test kits, a complete line of coagulation products, parasitology transport media, water, blood bank saline, standards and controls. We also provide comprehensive contract manufacturing services in Diagnostics and Biotechnology Formulation and Packaging. Wherever you are in the development/production process, such as the initial R&D phase, the Regulatory/Compliance process, or the final Warehouse/Shipping phase, we can accommodate your needs. Our focus, combined with the flexibility of our production/warehouse facilities, enables us to provide an unparalleled level of responsiveness to you, from bench to batch.

Services Offered
Our contract development services are headed up by a large, highly-qualified and experienced R&D team. In addition, we have over 1,000,000 square feet across all sites, refrigerator and freezer capacity, environmentally-controlled rooms ranging from Class 100 to Class 100,000 and capabilities in antibody production and purification, organic synthesis, lyophilization, and raw material, in-process and final product testing.

Our expertise includes:

• Pilot production
• Lot-size and process scale-up
• Equipment, process and software validation
• Manufacturing site transfer
• Liquid formulation and filling – aqueous lots up to 36,000L and lot sizes to 200,000 vials
• Ampuling, unit dose and aseptic filling capabilities
• Powder blending and filling – blend, screen, mill and fill in low humidity environments, lot sizes to 150kg
• Labeling and kit packaging services