Biopharmaceutical Process Development and Manufacturing

Robust, Reproducible, and Scalable Processes to Support Clinical and Commercial Success of New Biologics

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 you 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 discovery efforts transition into developability assessment and small-scale protein production to fully-integrated, comprehensive process development programs leading to large-scale 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 your biopharmaceutical process development needs.

Supporting Process Development for both Mammalian and Microbial Expression Systems

KBI has extensive experience with both microbial (E. coli) and mammalian (CHO) 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.

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 your needs, whether in producing small quantities of protein for research or in developing robust and scalable processes that can provide a solid competitive advantage.

Biopharmaceutical Process
Development Services