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Downstream processing of proteins: recent advances.

J R Ogez1, J C Hodgdon, M P Beal

  • 1Genentech, Inc., South San Francisco, CA 94080, USA.

Biotechnology Advances
|January 1, 1989
PubMed
Summary
This summary is machine-generated.

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This review highlights advancements in protein downstream processing since 1983, emphasizing integrated processes and innovations in chromatography. Key developments include enhanced process hygiene and regulatory considerations for biotechnological products.

Area of Science:

  • Biotechnology and Bioprocessing
  • Protein Purification
  • Chemical Engineering

Background:

  • Protein downstream processing has evolved significantly since 1983.
  • Innovations are driven by advancements in molecular biology and fermentation.
  • The integration of upstream and downstream operations is crucial for efficient development.

Purpose of the Study:

  • To review key innovations in protein downstream processing since 1983.
  • To highlight advancements in chromatography and biospecific adsorptions.
  • To discuss the impact of regulatory demands and process hygiene on manufacturing.

Main Methods:

  • Literature review focusing on innovations since 1983.
  • Expanded coverage of chromatography, including biospecific adsorptions.

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  • Analysis of regulatory issues and patent literature.

    • Main Results:

    • Significant achievements in integrated downstream operations.
    • Continued prominence and expansion of affinity chromatography.
    • Increased emphasis on process hygiene and regulatory compliance for biopharmaceuticals.
    • Emerging patent literature reflecting process development successes.

    Conclusions:

    • Unified process design is critical for successful and rapid development.
    • Advancements in chromatography and biospecific adsorption enhance protein recovery.
    • Regulatory considerations and hygiene are paramount for therapeutic proteins.
    • The field shows robust innovation, evidenced by patents and evolving manufacturing strategies.