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

Mariana N São Pedro1, Tiago C Silva1, Rohan Patil2

  • 1Department of Biotechnology, Delft University of Technology, Delft, The Netherlands.

Biotechnology and Bioengineering
|March 22, 2021
PubMed
Summary
This summary is machine-generated.

Continuous biomanufacturing requires reliable high-throughput process development (HTPD) technology. This paper identifies gaps in HTPD and proposes solutions for integrated continuous biomanufacturing.

Keywords:
high-throughput process developmentintegrated continuous biomanufacturingmicrofluidicsmodelingprocess analytical technology

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Area of Science:

  • Biotechnology
  • Chemical Engineering
  • Process Development

Background:

  • Continuous manufacturing, exemplified by the petrochemical industry, signifies industry maturity.
  • Patent expiry drives demand for more efficient and cost-effective biomanufacturing processes.
  • Regulatory agencies are increasingly encouraging the adoption of continuous biomanufacturing.

Purpose of the Study:

  • To identify critical gaps in high-throughput process development (HTPD) for continuous biomanufacturing.
  • To discuss the needs and potential solutions for achieving end-to-end integrated continuous biomanufacturing.
  • To review the current state of HTPD and emerging technologies in the field.

Main Methods:

  • Review of the current state-of-the-art in HTPD for various unit operations.
  • Discussion of emerging technologies relevant to continuous biomanufacturing.
  • Analysis of challenges and solutions presented at the 2019 Integrated Continuous Biomanufacturing conference.

Main Results:

  • Significant breakthroughs in continuous biomanufacturing have occurred over the last decade.
  • High-throughput process development (HTPD) is crucial for faster and cheaper process development.
  • Reliable HTPD technology for integrated continuous biomanufacturing remains an emerging and underdeveloped field.

Conclusions:

  • Addressing HTPD gaps is essential for the successful implementation of integrated continuous biomanufacturing.
  • Emerging technologies are key to accelerating the transition to continuous biomanufacturing.
  • Further development in HTPD is needed to support the industry's shift towards continuous processing.