Biopharmaceutical process development and manufacturing
The clinical and commercial success of biotherapeutics hinges on developing robust, reproducible, and scalable processes. KBI's extensive process development and analytical development capabilities help our partners generate active products at an attractive cost while enabling rapid, reliable transfer to cGMP manufacturing.
KBI's process development activities cover the full development cycle. We support early-stage discovery efforts through small-scale protein production to fully-integrated, comprehensive process development programs leading to cGMP manufacturing to process characterization and scale-down validation studies. We take pride in our deep knowledge and experience in the science and practice of biopharmaceutical drug development. Our abiding customer focus and situational flexibility combined with a solid scientific base enable us to be the ideal partner for our clients' biopharmaceutical process development needs.
Our process development services include:
KBI has extensive experience with both microbial (E.coli, yeast) and mammalian cell culture-derived proteins. The KBI team has worked with protein production processes at all scales, from laboratory, pilot, and clinical scales to commercial scales up to 2,000L. We have conducted cutting-edge research into several technologies fundamental to process development and are adept at solving challenging issues on very short timelines.
KBI has well-developed platform processes for monoclonal antibodies and Fc fusion proteins and has helped several clients create their own platforms for novel therapeutic moieties.
Our high throughput tools for process and analytical development include miniaturized bioreactors through the Ambr® platform, combined with high throughput chromatographic screening capabilities and a complimentary set of analytical tools to enable rapid progress in process development. Through our experience, we can readily develop optimal experimental strategies that can lead to the rapid development of robust, reliable, and scalable processes.
KBI’s full range of biopharma process development capabilities provides the tools to address client needs, whether in producing small quantities of proteins for research or in developing robust and scalable processes that can provide a solid competitive advantage.