Commercial Microbial
Commercial Microbial Manufacturing
The KBI Colorado site is our center of excellence for microbial process development and cGMP manufacturing (1500L fermentation scale). The Colorado site includes three buildings: R&D and analytical development labs (16,000 ft2), GMP Manufacturing and QC Labs (25,000 ft2), and GMP Warehouse and QA (37,000 ft2).
Learn more about our cGMP biologics manufacturing services
Our personnel has extensive experience with the development and manufacturing of microbial products.
The Colorado site has commercialized multiple products within the past six years, using quality-by-design (QbD) principles to develop, qualify, and manufacture protein-based therapeutic processes. With close ties between process and analytical groups, turn-around times for data is quick, providing near real-time analysis.
The site recently transitioned to a customer-focused structure, delivering on projects for multiple clients around the world, ranging from vaccines to monoclonal antibodies. In this capacity, the Colorado site has gained a reputation for speed, quality, and flexibility.
KBI has extensive expertise and experience with process commercialization and product support, including an ICH-aligned business process following a QbD-based strategy for product lifecycle management, starting at the earliest development stage and continuing through commercial manufacturing, launch and beyond.
The commercial process is managed through a control strategy that demonstrates and documents the process is in a state of control, and critical quality attributes (CQA) are within their targeted profiles.
