USSF integrated teams of specialists provide a seamless transition for API and drug substances from the initial discovery stages of the program to commercialization. Expertise and support at each phase of the drug program is available from development, analytical services, cGMP manufacturing and later stage development and commercialization. This includes transfer-in, optimization, scale up of formulation suitable for cGMP manufacturing.
USSF Analytical Development experts offer transferring, developing, qualifying, and validating client assays services with Analytical method screening and preliminary stability profile development.
Fermentation and Purification
USSF provides cGMP fermentation and protein purification services for Phase 1 clinical trials. All the critical equipment in the cGMP facilities have been qualified with Factory Acceptance Tests (FAT), IQ and OQ. Since 2000, USSF has successfully executed more than XX campaigns, resulting in IND filings by clients. Our GMP equipment includes three B. Braun fermenters with 30, 100, and 300 liter capacity. The culture harvest is performed by Alfa-Laval disc-stack centrifuge. cGMP laboratory is equipped with an Avestin Homogenizer (Model C160) for cell breakage to recover intracellular products.
The downstream processing purification is conducted in an ISO Class 8 or one of two ISO Class 7 suites. The cGMP protein purification suite is equipped with AKTA chromotography systems such as a Process skid, Pilot and Purifier. CBB staff are highly skilled in isolation of inclusion bodies and refolding at a large scale (500 Liters).
Formulation and Fill
USSF offers advanced formulation and fill services for every stage of development, from molecule to formulation to clinical studies.
Pack, Ship, and Storage
USSF industry best practices and standards based packing, shipping and storage services, including GIBCO custom media in the packaging that best suits your needs. Contact our sales team to learn about the different options for packing, shipping, and storage for liquid and powder media in a variety of package sizes, including small, intermediate, and large scale. Liquid Media packaging options, including product contact packaging and outer shipping containers, Dry Powder and AGT Media Packaging