Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.

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.