Single-Use Disposable Technologies for Biopharmaceutical Manufacturing

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A Case Study of Scale-up and Tech Transfer from Non-Disposable to Fully Disposable Systems

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The clinical and commercial success of biotherapeutics hinges on the development of robust, reproducible and scalable processes. KBI’s extensive process development capabilities help our partners generate active product at an attractive cost while enabling rapid, reliable transfer to  cGMP manufacturing.

Downstream_PD_Akta_smKBI process development activities cover the full development cycle, from supporting 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.

KBI has extensive experience with both microbial (E.coli, yeast) and mammalian cell culture derived proteins. Our team’s combined experience includes more than 50 IND submissions and more than 5 commercial launches. The KBI team has worked with protein production processes at all scales from laboratory, pilot and clinical scales to commercial scales up to 20,000L. We have conducted cutting-edge research into several technologies that are 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.Upstream_PD_sm

Our high throughput tools for process development include miniaturized bioreactors through the Ambr® platform combined with high throughput chromatographic screening capabilities and a complementary 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 process development capabilities provide the tools to address client needs, whether they be in producing small quantities of proteins for research or in developing robust and scalable processes that can provide a solid competitive advantage.

Process Development Service offerings include:

  • Selection of clones (productivity, stability)
  • Cell line evaluation
  • Cell line adaptation (e.g. to serum-free or suspension culture)
  • Medium development (animal component free)
  • Development of reproducible, robust and scalable processes
  • Development of nutrient feed strategies to prolong culture life and production
  • Optimization of existing processes
  • Identification of critical process parameters
  • Development of process control strategies
  • Production at pilot scale for preclinical studies
  • Development of novel technologies
  • Development of platform approaches
  • Scale-down model qualification
  • Scale-down process characterization studies
  • Scale-down validation studies
  • Viral clearance validation studies
  • Technology transfer package and support
  • Application of design of experiments during development and process design space mapping
  • Approaches and documentation aligned with QbD