Print Email Facebook Twitter White paper on high-throughput process development for integrated continuous biomanufacturing Title White paper on high-throughput process development for integrated continuous biomanufacturing Author Neves Sao Pedro, M. (TU Delft BT/Bioprocess Engineering) Picanço Castanheira Da Silva, T. (TU Delft BT/Bioprocess Engineering) Patil, Rohan (Global CMC Development, Sanofi) Ottens, M. (TU Delft BT/Bioprocess Engineering) Date 2021 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. Subject high-throughput process developmentintegrated continuous biomanufacturingmicrofluidicsmodelingprocess analytical technology To reference this document use: http://resolver.tudelft.nl/uuid:e873ee85-4cc0-49fa-9447-efb394cdc14d DOI https://doi.org/10.1002/bit.27757 ISSN 0006-3592 Source Biotechnology and Bioengineering, 118 (9), 3275-3286 Part of collection Institutional Repository Document type journal article Rights © 2021 M. Neves Sao Pedro, T. Picanço Castanheira Da Silva, Rohan Patil, M. Ottens Files PDF bit.27757.pdf 1.19 MB Close viewer /islandora/object/uuid:e873ee85-4cc0-49fa-9447-efb394cdc14d/datastream/OBJ/view