Advanced in the sense of technology or in the sense of the advanced product?

First things first: Advanced manufacturing is no natural relative of advanced therapy medicinal products (ATMP). There may be an epoch-making overlap of advancing technology with advancing medical product types – but both terms are not fundamentally related or pursued by regulators in parallel. So what is advanced manufacturing?

Advanced Manufacturing means a mix of at this point non-common but desired and emerging drug and medical device development and manufacturing technologies – be it for clinical trail use or for commercial manufacturing.

The most common vocabulary words in advanced manufacturing are currently continuous manufacturing (this has already made it into some guidelines), non-conventional emerging manufacturing techniques (e.g. additive manufacturing such as 3D-printing), and of course artificial intelligence supported manufacturing and quality management.

What in fact is the point of this?

Very simple: The advance is meant to be made in higher manufacturing flexibility, detaching from a pesky and unefficient batch-to-batch-to-yet-another-batch manufacturing approach, and of course saving money by reducing involvement of human staff.

Official and public intentions are there too of course: such as allowing for short notice product changeovers and setup of ad-hoc manufacturing facilities where needed, even the hope of regulators that some companies won´t find that many undetected loopholes in quality decisions any more once the quality system itseld is run by AI.

Already there, but not all the way there.

It is clear that none of this is at this point very pervasive to the drug and device making industry, not by and large. But it is surely desired by more and more companies, because as mentioned above it carries a lot of potential concerning flexibility of manufacturing and even development. It condenses lead and realization times, and in the end it will save a company quite a bit of cash – and this is and will(!) be the driving factor for the industry.

However, it is picking up speed and just as the topic has arrived in the heads of the regulators too already, the commensurate regulations are not there yet. Some agencies are trying hard to not miss the boat (e.g. US FDA), but for others it seems that they will have missed it for sure in the near future. And this will slow down innovation simply because regulatory submission will be an extra hurdle, and because regulatory oversight will be somewhat vague to manage – traditional standards may not suit the needs of emerging technologies in drug and device manufacturing and control, not to mention application of advanced quality management systems.

Questions for Advanced Manufacturing

Some of the more visionary but soon very real questions for advanced manufacturing are:

Who among the industry will be able to jump on this train? Are we going to see just the big shots doing this and „the rest of them“ being not even able to invest in a transition to advanced manufacturing?

Next question: How much of a battle will it be for a company to satisfy their regulators and especially their local governmental supervisors, e.g. (c)GMP-inspectors?

And when it comes to AI: How about the issue of responsibility for quality decisions? Assuming AI´s capabilities to contribute to quality and process control as well as to quality relevant decisions will surpass the human intellect and its capacity and speed to make right decisions, to act and to react in a quality system or process control system: who then will be responsible for it and how will this impact the human workforce?

Advanced Manufacturing: some Good, some Bad, but not altogether Ugly.

Not all of these questions the regulators must answer to. But answers will form eventually. And it seems clear that if governments want to fuel the development of advanced manufacturing for a greater good (e.g. more robust supply of drug products in emergency scenarios), then the same government must consider how such a step may backfire on factors such as employment and market polarization within the for example pharmaceutical or medical device industry. Chances are the diversity will drop more and more, and only a few large corporations will own people´s health. And this may not stay limited to Orwell-like theoretical fantasy scenarios forever.

Now does this mean advanced manufacturing should not be pursued or that this is „pandora´s box“? Well, it may be some of that. But it is bound to come, so engaging it and engaging it´s potential to improve people´s lifes is certainly the way to go.

At least at ExpertsInstitut this is our policy and practice.

Dr. Dietmar Gross

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