SAFC’s St. Louis, Missouri (USA) campus is a key center of manufacturing excellence in cGMP biologics, with over 25 years experience in plant- and animal-based therapeutic protein extraction and purification, bio-conjugation, excipients and adjuvants manufacturing. In addition, SAFC St. Louis works in close alignment with SAFC’s Madison (Wisconsin) Highly Potent APIs (HPAPI) manufacturing operations to lead the industry in its ability to handle high potency conjugation projects.
Completely segregated manufacturing operations support customer requirements for large-scale programs, with capabilities to extract biomass at up to 6,500 kg/week, then purify material in chromatography columns up to 1.5 meters in diameter in a clean room environment. Extensive analytical capabilities and dedicated compliance resources, along with extensive manufacturing capabilities help SAFC customers around the globe to accelerate their biologic drug development programs.
SAFC’s clinical ADC manufacturing facility was purpose-built for the handling of HAPIs, antibodies, linkers and for performing complex conjugation processes in a cGMP suite featuring isolators and specialized handling equipment.
For commercial scale-up, a new 10,000 sq-ft manufacturing suite is opening mid-2015:
Purpose-built, completely segregated facilities have been specifically designed to support animal protein extraction and purification at commercial scale to meet growing customer demand for animal-sourced therapeutic proteins.
Manufacturing for sample projects includes:
The St. Louis cGMP facility was specifically designed to handle the increasing demand for key intermediates, excipients, adjuvants and APIs made from plant-derived materials. SAFC’s dedicated upstream plant biomass extraction and clarification facility is equipped to process up to 6,500 kg of plant biomass/week. Facility features:
Complete analytical support, from development of specifications, risk assessment, implementation of process controls and validated cleaning procedures. In addition, our analytical capabilities offer:
SAFC’s project managers lead multi-functional teams and serve as the single point of contact for customers to help facilitate the timely communication of important technical information and production timelines.