White paper on high-throughput process development for integrated continuous biomanufacturing
M. Neves Sao Pedro (TU Delft - BT/Bioprocess Engineering)
Tiago Castanheira Picanço Castanheira Da Silva (TU Delft - BT/Bioprocess Engineering)
Rohan Patil (Global CMC Development, Sanofi)
M Ottens (TU Delft - BT/Bioprocess Engineering)
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Abstract
Continuous manufacturing is an indicator of a maturing industry, as can be seen by the example of the petrochemical industry. Patent expiry promotes a price competition between manufacturing companies, and more efficient and cheaper processes are needed to achieve lower production costs. Over the last decade, continuous biomanufacturing has had significant breakthroughs, with regulatory agencies encouraging the industry to implement this processing mode. Process development is resource and time consuming and, although it is increasingly becoming less expensive and faster through high-throughput process development (HTPD) implementation, reliable HTPD technology for integrated and continuous biomanufacturing is still lacking and is considered to be an emerging field. Therefore, this paper aims to illustrate the major gaps in HTPD and to discuss the major needs and possible solutions to achieve an end-to-end Integrated Continuous Biomanufacturing, as discussed in the context of the 2019 Integrated Continuous Biomanufacturing conference. The current HTPD state-of-the-art for several unit operations is discussed, as well as the emerging technologies which will expedite a shift to continuous biomanufacturing.
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