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Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.

Christopher L Burcham1, Alastair J Florence2, Martin D Johnson1

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The pharmaceutical industry is shifting towards continuous manufacturing for new therapies. This review examines the transition from batch to continuous processing for active pharmaceutical ingredients (APIs) and drug products.

Keywords:
continuous manufacturedrug productdrug substancepharmaceuticals

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Area of Science:

  • Pharmaceutical Manufacturing
  • Chemical Engineering
  • Process Chemistry

Background:

  • The pharmaceutical industry is increasingly adopting continuous processing for novel therapies.
  • This shift is supported by regulatory bodies and driven by benefits like cost reduction and improved quality.

Purpose of the Study:

  • To review the transformation from traditional batch manufacturing to continuous processing in the pharmaceutical industry.
  • Focus on small, chemically synthesized organic molecules for both APIs and drug products.

Main Methods:

  • Literature review of continuous manufacturing processes.
  • Analysis of regulatory filings and published examples of continuous processing for APIs and drug products.

Main Results:

  • Continuous processing is established for drug product manufacturing.
  • Published examples of continuous active pharmaceutical ingredient (API) manufacturing under cGMP are emerging but lag behind drug product filings.

Conclusions:

  • Continuous manufacturing offers significant advantages over batch processing for pharmaceuticals.
  • Further development and regulatory submissions for continuous API manufacturing are anticipated.