Microbial factories for recombinant pharmaceuticals

Neus Ferrer-Miralles1, Joan Domingo-Espín, José Luis Corchero

  • 1Institut de Biotecnologia i de Biomedicina, Universitat Autònoma de Barcelona, 08193 Barcelona, Spain. antoni.villaverde@uab.cat.

Insights

Microbial systems like bacteria and yeast are robust hosts for producing approved recombinant protein drugs, despite challenges in mammalian protein production. Their continued use highlights their effectiveness in biopharmaceutical manufacturing.

Area of Science:

  • Biotechnology and Biopharmaceutical Manufacturing
  • Recombinant Protein Production
  • Microbial Host Systems

Background:

  • 151 recombinant pharmaceuticals approved by FDA/EMEA primarily use microbial hosts (bacteria, yeast).
  • Microbial systems present challenges: unconventional post-translational modifications, proteolytic instability, poor solubility, and cell stress responses.
  • Despite challenges, microbial systems remain powerful tools for recombinant protein production.

Purpose of the Study:

  • To summarize the nature, properties, and applications of approved recombinant pharmaceuticals.
  • To comparatively analyze features of current and potential microbial host systems for protein drug production.

Main Methods:

  • Review and comparative analysis of existing literature on recombinant pharmaceuticals.
  • Evaluation of microbial production systems (Escherichia coli, Saccharomyces cerevisiae) and their performance.
  • Assessment of challenges and advantages associated with microbial protein production.

Main Results:

  • Microbial systems, particularly E. coli and S. cerevisiae, are extensively used and proven robust for producing approved recombinant drugs.
  • The market entry of protein drugs from non-microbial systems has not diminished the development of microbially produced biologics.
  • Despite inherent production bottlenecks, microbial systems offer a reliable platform for biopharmaceutical development.

Conclusions:

  • Microbial cellular systems are indispensable and robust platforms for the production of a significant number of biopharmaceuticals.
  • Continued innovation in microbial strain development and process optimization is crucial for future recombinant protein drug manufacturing.
  • Comparative analysis of host systems underscores the enduring value and potential of microbial production platforms.

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