Wanted – State of the Art Pharmaceutical Manufacturing Plants

Wanted – State of the Art Pharmaceutical Manufacturing Plants

In recent years I’ve increasingly heard clients wanting state of the art pharmaceutical manufacturing plants or medical device manufacturing plants. Not fully understanding what this actual brief means, I have always asked for clarification, after all our company and our partners need to design, build and validate it. Obviously, this is a complex brief, I think arising from a general unhappiness with current performance. As a trained, experienced and certified Professional Production Manager I’m always driven by the process requirements, the optimization thereof and then I look to wrap the building and services around it later. I have also learnt that I or we (PharmOut) don’t have all the answers and would like to set up forums to drive Pharmaceutical Manufacturing Innovation, so we would like to work with innovative manufacturers and suppliers to navigate through the uncertain times ahead!

State of the art

Going back to the state of the art design brief, often the preliminary design vision sometimes includes Automated Guided Vehicles, as cool, oh and they always want “automation” as in Manufacturing Execution Systems or a lights out warehouse. Then in practice, when we come to design and build the “state of the art” (tablet) plant, we end up specifying and installing old process technology, so old, our grandparents could have designed it. So hardly state of the art! My other frustration, is that the existing bought building or the new bespoke building design / construction is well ahead of the process design / equipment choices, leading to compromises like height restrictions, locating ablutions above manufacturing, and with many projects, the original poorly justified budgets starts driving design decisions and process technology choices.

Many factors eliminate innovation, and progressive thinking, especially the killer statements: “that sounds too risky”, “we don’t do it that way”, and “we tried that before but it didn’t work”!

This has led me to actively pursue the notion of what exactly is “state of the art” manufacturing, and what will it look like. Thankfully there are incredibly bright people already out there doing the heavy lifting for us. I’m fascinated by the Industry 4.0 initiative. Many people are on the cusp the 4th manufacturing revolution. Historically, the huge growth in productivity is attributed to 3 technological leaps. Namely, the industrial revolution, i.e. the engine (steam), mass production, thanks Henry Ford, and lastly the computerisation / automation wave and the internet.

Bringing manufacturing home

However, for the last 50 years there has been little growth, namely because we have concentrated our manufacturing in what Tom Peters might call “centers of cheapness”. The problem is that “cheap labour” does not remain “cheap” for long. There are a number of manufacturing case studies showing manufacturing now being more expensive in Brazil than France and the forecast is that the average manufacturing cost between China and the USA be on par by 2018. So similar manufacturing costs, but arguably a perception of poor quality from some of these emerging economies. I have written before about the Booming Australian Complementary Medicines Manufacturing Industry, this is selling brand “Australia” as a manufacturer of high quality, trusted products and the role of the TGA is establishing this trust, well done to everyone within the industry.

Concentrated mega factories have led to complicated and rigid logistical supply chains, resulting in higher environmental costs of these long supply lines and of course higher stock levels.

Pharmaceutical Industry 4.0

The next revolution

Personally, I don’t think of some new technologies as “disruptive technologies”. It is the customers who are the disrupters, and the technology is simply an enabler. So when we look at the 4th Revolution, Cyber Physical Systems, and the associated emerging technologies like additive manufacturing, robotics, they can provide fast, affordable, flexible supply of high quality products.

Expanding on the topic of emerging technology and using additive manufacturing/3D printing, we have seen some recent shifts. Whilst being common in plastic manufacturing for a number of years, the shift to printing in titanium, stainless steel, and silicon now for under $4,000 is phenomenal! More recently we saw a US FDA approved 3D printed tablet called SPRITAM. Will customers demand personalized medicines where they can walk into a pharmacy and Bluetooth across a script to a 3D printer that will print a bespoke/personalized medicine and walk out? Maybe, but imagining the future like this always fills me with excitement and awe.

One of the main bridges between the physical and digital applications enabled by the fourth industrial revolution is the internet of things (IoT). In its simplest form, it can be described as a relationship between things (products, services, locations, etc.) and people that is made possible by connected technologies and IT platforms.

Did you know that in one recent study a pharmacist was identified as one of the 8th most likely professionals prone to replacement by automation, and 86% felt this will happen in the US by 2025. If you look at the tremendous process of blockchain, already used in many applications (aside from BitCoin), unique, secure patient records could be around the corner. Admittedly there is still a significant gap between, Netflix predicting your next movie or your iPhone telling you where you parked your car, or how long it will take to get home, but arguably a robotic AI pharmacist with full access to health records, and an encyclopedic knowledge of drug interactions could be interacting with the doctor at the point of writing the prescription. As I mentioned we are on the cusp of a revolution.

And the regulations?

The regulatory framework to ensure patient safety will be really interesting, I heard a fascinating talk by Bill Turner yesterday from the Office of Drug Control, an example of this is Medicinal Cannabis. Customers, or rather voters, are demanding the legislation of cannabis. Watching how an enabling legal framework is established by a political will, then the regulatory changes to enable this is fascinating to watch up close and personal.

Another is the so called additive manufacturing, or 3D printing. To explain the technology, it consists of creating a physical object by printing layer upon layer from a digital 3D drawing or model. This is the opposite of the traditional subtractive manufacturing, which is how things have been made until now, with layers being removed from a piece of material until the designed shape is obtained. We are not sure how the large device manufacturers will react to their customers not wanting $1m dollars worth of kit, with every possible size and configuration to “check out” and “check back in” after each procedure plus sterilize through the CSSD vs the customized, bespoke device, an exact match to the patient, how to regulate this shift?

How will the future look?

To discuss innovation and regulatory changes, we are looking to suppliers and manufacturers to discuss what the state of the art Australian manufacturing facility of the future will be like. Practical things we can do now, well continuous manufacturing for tablet plants is available, so are robotics, see Mr Frank Maguire at a recent 2016 PharmOut GMP & Validation Forum with a robotic arm.

We have set aside an Innovation Evening of the 15th November 2016 and locked two days for a Pharmaceutical Innovation Forum on 24th and 25th July 2017, we desperately need your help in trying to visualise the future of Australian Pharmaceutical Manufacturing.

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