The Potential of Continuous Sterile Manufacturing - Pharmaceutical Technology

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PharmTech Europe

The Potential of Continuous Sterile Manufacturing
Sterile manufacturing may be the next aspect of pharmaceutical manufacturing to consider in the continous process paradigm.

Pharmaceutical Technology
Volume 9, Issue 32

Watson: Continuous processing technology has been available and practical for more than a decade, but it has yet to be embraced by a pharmaceutical manufacturer. Neovex is still in the exploratory stages of applying continuous process technology in the pharmaceutical and biotech industries in the US. A both good and bad attribute of the pharmaceutical industry is that it is very slow to change accepted manufacturing practices. Ongoing assessment of continuous production at a few large pharma companies is an encouraging sign. Positive assessment of the technology and QA/QC validation techniques will likely lead to nonoperational, pilot-plant test platforms.

For pharmaceutical companies, the major challenges to acceptance of continuous processing will be developing internal comfort with a new approach, lack of financial necessity, and getting FDA agreement to and codification of quality validation standards. Hopefully, the process analytical technology (PAT) initiative will address and resolve these issues. The hurdle for continuous process technology in the pharmaceutical industry is mainly emotional and regulatory, not technological. The equipment and technology to support continuous production is available and operationally validated. The pharmaceutical industry could implement continuous production techniques right now.

Our experience to date shows that the biotech portion of the pharmaceutical industry will be the first to embrace continuous production. The serious diseconomies of scale of large batch biotech production are driving the cost of production facilities into the stratosphere. Also, the technological and design challenges of ever-larger batch systems are becoming acute and expensive to resolve. As biotech engineers come to understand the dramatic facility, capital, and production cost savings of continuous production, they will start to embrace the technology.

PharmTech: What do you see as the key regulatory/compliance issues in moving from batch to continuous processing? In what ways, if any, is the FDA or other regulatory authorities facilitating the evaluation or move to continuous processing (such as through the PAT initiative)?

Watson: Both US and European regulators are starting to understand the significant quality and safety benefits of continuous production. They are beginning to come to grips with 'fail-safe' design and starting to explore alternative testing, process control and validation methods. Something as simple as the concept of a 'batch' sheds light on the scope of the changes that will be made. All our validation processes revolve around the 'batch.' In continuous production, there really is no batch, no start or end. Any definition of batch size is arbitrary and part of a transition from batch thinking to continuous thinking. The PAT initiative, however, is an excellent start down that path.

For more information on continuous processing, see "Continuous Processing: Moving with or against the Manufacturing Flow".


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