iSpeak Blog

Why You Should Care about Continuous Manufacturing

Paul Collins

Continuous Manufacturing of pharmaceuticals has been an extremely popular topic in our field for the past ~ 10 years or so. You see it in heavily academic circles. You see it in heavily industrial circles. And you see it being talked about by regulators in the US, Europe, and Japan. But, those of us that have been around for a while have seen all kinds of topics of interest come and go over the years – with, all too often, an emphasis on the “go.” Many folks view these transient events as fitting their “flavor of the day” mentality regarding new technology incorporation. For those that subscribe to the “flavor” theory, Continuous Manufacturing may appear to be yet another in a long line of technology “initiatives” for pharma.

From my view, approaching Continuous Manufacturing in the same manner as some of the other technology approaches of the past is a mistake, even though I believe all of the approaches were attempting to address the same thing. The FDA launched the Quality by Design (QbD) initiative 15 years ago. While some may believe that Quality by Design (QbD) was unsuccessful and is now gone, the fact is that Quality by Design (QbD) is alive and well – it’s just looking for the right vehicle to bring it to fruition. And that’s what I believe Continuous Manufacturing is – it’s the right vehicle to make Quality by Design (QbD) become a reality. Continuous Manufacturing offers so much in terms of process monitoring, control, and robustness. Imagine a pharmaceutical manufacturing sector that was fully continuous, with continuously monitored process variables and actual feedback process control to maintain quality-indicating parameters within limits at all times. THAT would be an approach that satisfied the intents of Quality by Design (QbD).

On the other hand, it is naïve to think that we’ve already arrived at the mythical “desired state.” There is still a lot of work to be done to make all that happen, even though fantastic results have been demonstrated to this point. And beyond the technical needs, we’ll continue to encounter situations where the current regulatory environment needs modification to bring about the future. That’s why the 2018 ISPE Continuous Manufacturing Workshop is one you should attend – Continuous Manufacturing is the future, but we still haven’t achieved the desired state. It remains an area open to ideas and influence, with solutions that you can help define. This workshop is located conveniently in the Washington DC area and is a great opportunity to not only hear what the current state is of Continuous Manufacturing, but to engage with industrial, academic, and regulatory practitioners on how we fully achieve the future for pharmaceutical manufacturing.

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Continuous manufacturing continues to be one of the most talked-about pharma trends. Be prepared to transform your operations! Hear from renowned global industry, regulatory, and academic experts who will discuss both new molecule processes and batch-to-continuous conversions at ISPE's 2018 Continuous Manufacturing Workshop.

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