Continuous manufacturing operations can provide improved efficiency for biopharmaceutical manufacturing. Consistency of product quality is improved through extended periods of steady-state operations. Reduced capital expenditure is achieved through process intensification and subsequent reduction in size for equipment as well as the operating facility. The process architectural paradigm for a “Factory of the Future”must be customized to enable continuous raw material feed, operation and final product storage.
Significant advances have been made in the understanding of these opportunities for biologics, many in combination with Single Use technologies. Currently available capabilities for upstream and downstream unit operations and process control strategies will be discussed.
POINTS TO TAKE AWAY
Present the current state of technology for biologic continuous unit operations, including perfusion bioreactors, filtration, chromatography, etc.
Define advantages for use of continuous processing, recognizing operational and regulatory factors in the manufacturing environment.
Highlight near-term challenges and opportunities in the development of a fully continuous process for the production of biologic and vaccine products.
Speaker: Sue Behrens | Senior Director, Process Design, IPS – Integrated Project Services, LLC
Dr. Sue Behrens is a consultant with over 25 years’ combined experience at IPS, SB Executive Consulting, LLC and Merck. As the lead for the Process Design group at IPS, Sue focuses on global projects for technically complex facilities for the Life Science industry. She has expertise in production of vaccine and biopharmaceutical products, including process development, technology transfer, supply chain strategy, facility design/validation and regulatory CMC support. Sue is also the founding Sponsorship Chair for the Philadelphia Chapter of Women in Bio. She earned her BS and PhD degrees in Chemical Engineering from University of Michigan and University of California-Berkeley.