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APIs & Continuous Flow Manufacturing

continuousContinuous drug manufacturing is reported to have begun with Novartis and MIT a decade ago, but no one would dare argue that it’s taken off like a rocket ship in the intervening years.

As a topic, it’s seen a fair amount of coverage lately – from these pieces at PharmTech (Steps Closer to the Adoption of Continuous Processing and The Mainstreaming of Continuous Flow API Synthesis) to Contract Pharma (Continuous Granulation Technology Trends) and others.

The pharma industry in general has been wary of – and slow to embrace – continuous manufacturing for a number of reasons, including cost, technical complexity, and (until more recently) a hazy, uncertain regulatory environment.

But continuous manufacturing isn’t an unproven technique. The food, chemical, electronics and other industries have utilized continuous production for years – as was pointed out in the feature article at ContractPharma on granulation.

FDA is Onboard
Recent support from the FDA has done much to promote continuous processing. In fact, with regulatory agencies starting to push the technique, the single largest obstacle may finally be falling by the wayside.

Advantages of Continuous Flow Manufacturing of APIs

There are numerous reasons continuous processing is gaining favor in the pharma and biotech industries. Among them:

  • Faster processing speed and improved reliability
  • Better product quality and consistency
  • Higher processing efficiency, and minimization of raw materials, hazardous chemicals & reagents, and their respective waste streams
  • Lower production costs, with savings of 10-40+% over batch processes
  • Smaller equipment & process footprints.

While the promise of continuous flow manufacturing is huge, so are some of the hurdles. Among the challenges are two in particular:

  • Infrastructure & Regulatory Limitations
    The fact remains, virtually all existing commercial process chemistry infrastructure is designed for batch production. As continuous flow processing picks up steam, companies will begin to implement it – likely in a piecemeal fashion that will minimize the need to alter and requalify existing processes while bringing new products online with the newer technologies/techniques.
  • Continuous Flow Equipment
    One of the historic limitations for the adoption of continuous processing has been a lack of capable (read: scalable) equipment, though that is rapidly changing. A PharmTech article from 2013 discussed the issue of scalability:

    “One of the biggest issues for continuous flow chemistry has been scaling up to commercial production levels, because most early equipment for flow chemistry was designed for the laboratory.”

Fact is, some APIs will likely remain batch-dependent – whether for economic reasons or due to a molecule’s limitations in a continuous process format.  At the same time, those APIs which don’t adapt well to large batch-mode processing will transition to new techniques that allow the industry to capitalize on the different production format.

With the abundance of changes we’ve seen over the last two decades, this is definitely a fascinating time for the pharma industry. It will be interesting to see how quickly – and to what extent – the transition away from batch production occurs – both with APIs as well as downstream processing and finished dosage production.

What experiences have you had with continuous versus batch processing?

 

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