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Developments and opportunities in continuous biopharmaceutical manufacturing.

Ohnmar Khanal1, Abraham M Lenhoff1

  • 1Department of Chemical and Biomolecular Engineering, University of Delaware, Newark, DE.

Mabs
|April 12, 2021
PubMed
Summary

Continuous biomanufacturing offers a path to lower drug costs and faster production. This approach improves efficiency and accessibility, addressing current challenges in biologics manufacturing.

Keywords:
Biopharmaceuticalsbioprocessingbiosimilarschromatographycontinuous manufacturingfiltrationmonoclonal antibodiesperfusion cultureprocess analytical technologyviral inactivation

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Area of Science:

  • Biotechnology
  • Pharmaceutical Manufacturing
  • Process Engineering

Background:

  • Current biologics manufacturing methods are costly, leading to high drug prices.
  • There is a growing demand for biologics that strains existing production capacities.
  • Traditional manufacturing involves segmented unit operations, hindering efficiency.

Purpose of the Study:

  • To discuss recent advancements in continuous biomanufacturing.
  • To highlight the benefits of implementing continuous biomanufacturing.
  • To address the challenges in integrating continuous biomanufacturing processes.

Main Methods:

  • Review of recent technological developments in biomanufacturing.
  • Analysis of the integration, monitoring, and control of unit operations.
  • Discussion of efficiency improvements in equipment, footprint, and labor utilization.

Main Results:

  • Continuous biomanufacturing can increase the production of consistent-quality drugs.
  • Implementation can lead to lower manufacturing costs and faster production timelines.
  • Improved efficiency in resource utilization enhances drug accessibility.

Conclusions:

  • Continuous biomanufacturing presents a viable solution to reduce drug costs and improve patient access.
  • Overcoming integration and control challenges is key to widespread adoption.
  • Technological progress supports the shift towards more efficient biomanufacturing practices.