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Current challenges and recent advances on the path towards continuous biomanufacturing.

Milos Drobnjakovic1, Roger Hart2, Boonserm Serm Kulvatunyou1

  • 1Systems Integration Division, National Institute of Standards and Technology, Gaithersburg, Maryland, USA.

Biotechnology Progress
|July 26, 2023
PubMed
Summary

Continuous bioprocessing offers efficiency and sustainability benefits over batch manufacturing. Key challenges in Quality by Design (QbD), process integration, and data management hinder widespread adoption of continuous biopharmaceutical manufacturing.

Keywords:
continuous biomanufacturingknowledge managementprocess integrationprocess intensificationquality by design

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Chemical Engineering
  • Process Optimization

Background:

  • Continuous bioprocessing presents a more efficient, sustainable, and cost-effective alternative to traditional batch manufacturing for the biopharmaceutical industry.
  • Despite its advantages, continuous bioprocessing faces significant hurdles to widespread commercial adoption.

Purpose of the Study:

  • To provide an overview of the technological roadblocks impeding the extensive adoption of continuous bioprocessing.
  • To highlight recent advancements that can help overcome these identified challenges.

Main Methods:

  • Identification of three key areas for improvement: Quality by Design (QbD) implementation, upstream and downstream technology integration, and data/knowledge management.
  • Exploration of challenges within QbD, including process control, Process Analytical Technology (PAT), Critical Process Parameter (CPP) identification, and mathematical modeling.
  • Examination of difficulties in end-to-end process integration, focusing on downstream processing.
  • Outline of data and knowledge management issues and potential solutions, emphasizing ontologies and data standards.

Main Results:

  • Quality by Design (QbD) implementation requires robust process control, PAT, CPP identification, and mathematical modeling for successful realization.
  • End-to-end integration, particularly in downstream processing, remains a significant challenge for continuous biomanufacturing.
  • Effective data and knowledge management, driven by ontologies and data standards, is crucial for advancing continuous bioprocessing.

Conclusions:

  • Overcoming technological roadblocks in QbD, process integration, and data management is essential for the widespread adoption of continuous biopharmaceutical manufacturing.
  • Advancements in PAT, process modeling, and data standardization are key enablers for realizing the full potential of continuous bioprocessing.
  • The shift towards continuous manufacturing promises a more optimal, efficient, and sustainable future for the biopharmaceutical market.