Overview
KBI Biopharma is a global CDMO providing end-to-end biologics development and manufacturing, from cell line development to commercial cGMP supply. They specialize in complex molecules like mAbs, Fc-fusions, multispecifics, and conjugates using platforms such as SUREtechnology Platform™ and PUREplatform™. Capabilities include advanced analytical characterization, process development, formulation, and state-of-the-art facilities with 10 x 2,000L single-use bioreactors.
Frequently asked questions
- What biologics development and manufacturing capabilities does KBI Biopharma offer?
- KBI provides comprehensive services from cell line development, process and analytical development, formulation, to clinical and commercial cGMP manufacturing for complex molecules including mAbs, multispecifics, and conjugates.
- What regulatory standards does KBI Biopharma comply with?
- KBI adheres to cGMP standards for preclinical, clinical, and commercial supply of therapeutics and vaccines, with reliable manufacturing processes developed in-house or transferred from clients.
- What are KBI Biopharma's manufacturing facilities and capacities?
- Facilities include 10 x 2,000L single-use bioreactors for mammalian processes and a 2,000L fermenter for microbial, supporting high-titer production across clinical and commercial scales.