Scaling from bench to manufacturing for a mammalian or microbial process is very similar, despite the organisms having drastically different upstream growth profiles and requirements. Likewise, the downstream processes for both mammalian and microbial processes are very similar in general concepts with regards to protein purification strategies. In general, scale-up is considered a linear progression from the bench scale to the larger manufacturing scale, but not every parameter can scale linearly. Whether a process is able to scale linearly is dependent on process development robustness and compatible equipment design. The more robust the process development and the more similar the small-scale equipment to the large-scale equipment the more linear the process will scale. This webinar will focus on the equipment adaptations required for execution of upstream and downstream processes at the manufacturing scale considerations covered include adaptation to different types/designs of manufacturing equipment as well as linear vs non-linear scaling as result of equipment design differences between the small-scale and large-scale equipment. This webinar will focus on common parameters used for organism growth and protein purification with a focus on mixing/agitation, gas flow, chromatography and filtration scaling. Case studies will be presented to provide examples of an ideal scale-up scenario and a more creative solution to equipment adaptation problems as scale-up is not simply equations and multiplication but requires an understanding of how the equipment being used can impact the organism or protein, i.e. as mixing/agitation rates may not be a linear multiplication because the number of impellers present on the shaft generate different mixing profiles. By the end of the webinar, participants should have a general understanding of the concepts and tools required to successfully scale a process from bench to manufacturing.
Stephanie Wickham Ph.D., Director of Manufacturing Sciences, Cytovance Biologics
Dr. Stephanie Wickham has over 16 years’ experience in research and industry cell culture and protein purification. Graduate and post-doctoral fellowships focused on transfection, fermentation and purification of proteins from mammalian and microbial hosts while studying structure/function protein interactions and developing small molecule enzyme inhibitors. Her focus at Cytovance has been process transfer into manufacturing, designing scale-up processes and documentation, and leading the MST team as they help every client transition from bench-to-full-scale clinical supply batches. Areas of expertise in transfer include mammalian upstream and downstream along with microbial upstream and downstream producing various proteins ranging from monoclonal antibodies, enzyme, fusions, and cytokines. Dr. Wickham received a B.S. in Chemistry and Mathematics and a Ph.D. in Microbiology.
Who Should Attend?
This webinar will appeal to entry level professionals from the pharmaceutical and biotechnology industry and research/academic institutions including:
- R&D Scientists
- Manufacturing Science and Technology
- Manufacturing Engineers
- Manufacturing Scientists
- Process Engineers
What You Will Learn
Attendees will learn about:
- Information required for a process transfer
- How to scale, based on equipment design
- Common factors used for both mammalian and microbial processes
Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule APIs from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical CMC activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.