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Review
. 2021 Sep;118(9):3275-3286.
doi: 10.1002/bit.27757. Epub 2021 Apr 2.

White paper on high-throughput process development for integrated continuous biomanufacturing

Mariana N São Pedro  1 , Tiago C Silva  1 , Rohan Patil  2 , Marcel Ottens  1
Affiliations
Review

White paper on high-throughput process development for integrated continuous biomanufacturing

Mariana N São Pedro et al. Biotechnol Bioeng. 2021 Sep.

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.

Keywords: high-throughput process development; integrated continuous biomanufacturing; microfluidics; modeling; process analytical technology.

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Conflict of interest statement

The authors declare that there are no conflict of interests.

Figures

Figure 1
Figure 1
Workshop participants background: (a) Area where the participants work in: Industry, academia, or regulatory agencies; (b) Function/Department where the participants work in: USP, upstream processing; DSP, downstream processing; process development, which implicates both USP and DSP function; and analytics. (c) Descriptive constitution of each of the eight groups formed during the workshop, according to the area/function of each participant
Figure 2
Figure 2
Major gaps indicated for high‐throughput (HT) development in integrated continuous biomanufacturing (ICB) by the participants in the workshop
See this image and copyright information in PMC

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