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Advances In Manufacturing Are Paving The Way For New Medicines

As advances in life sciences have begun to produce new medicines to treat a wide range of serious diseases, new therapies are generating headlines and hope. Cancers, diabetes, hepatitis, autoimmune conditions such as arthritis and other serious afflictions are all yielding to a relatively new category of immunotherapy treatments, Forbes writes. The prospect is for more of these powerful medicines – known as “biologics,” or, in their generic versions, as “biosimilars.”

Standing behind these therapies, however, and out of the limelight, are the manufacturing processes and systems needed to make these therapeutic proteins.

These processes require serious innovation too. Without that kind of creativity, the new therapies – which are often exponentially more complex than more traditional medicines – simply cannot be made on the scale and with the speed, reliability, and traceability needed to fulfill their promise.

Consider insulin.

Tens of millions of American diabetics rely on it. But there is no way we could supply them all if the only source were stillcattle and pig pancreases, as was the case when it was first discovered.

So it’s worth taking stock:  What kinds of processes are needed to produce the new therapies scientists are giving us? And where do we stand in developing them?

To answer those questions, it helps to have a little more background on some of the challenges the life sciences industry faces.

First, consider how complex many of the new breakthrough medicines are compared to more traditional drugs. Traditional drugs are made in a sequenced process of specifically defined chemical reactions and traditional chemical separations.

They’re typically smaller molecules  that can be taken orally.

Biologics and biosimilars, by contrast, are very large molecular structures, manufactured by living cells (hence “bio”), and consist of proteins or protein building-blocks. Biologics can only effectively reach the bloodstream via injection.

So making a small-molecule drug can be compared to baking a cake – sometimes a simple sheet cake, sometimes an elaborate wedding cake. But making a biological or biosimilar is like preparing a five-course dinner at a French restaurant with three Michelin stars.

 Few of us ever eat at a place like that, but hundreds of millions of us will soon be clamoring for the medicinal equivalent. As populations age in places such as the United States, Europe, and Japan, new therapies offer hope against time’s ravages. As they grow wealthier – in China and India, for example – hundreds of millions enter the healthcare system for the first time.
Meanwhile, our greater understanding of genomics is giving rise to personalized medicine, which involves the use of customized biologics to target individual or group needs. Finally, globalization is increasing the threat from localized epidemics like Ebola, which need to be stamped out rapidly to avert large-scale catastrophes.

Add it all up, and you get an urgent need for increased, highly precise and flexible manufacturing capacity, at a lower capital cost. That, in turn, requires:

·         “Single-use” technologies, which can produce relatively small quantities of product to respond to a localized crisis or personalized medicine, and do so quickly, reliably, safely and economically, without the expense of fixed capital investments.

·         Continuous manufacturing processes, which will enable countries like China and India to manufacture larger product volumes in smaller spaces without the frequent shutdowns and startups associated with “batch” production.

·         “Pharma 4.0,” which will connect people, data, and machines (through the Internet of Things — IoT) to ensure the fastest and most useful information is available for all phases of drug manufacturing, from design and manufacturing to monitoring and reporting.

None of this is simple. But in each case, dramatic advances are being made.

Single-use technologies, for instance, are already enabling flexible, multi-product, small batch production, which is crucial for personalized medicine. Modular construction lowers plant capital costs dramatically while enabling the ultimate in manufacturing flexibility. Products – monoclonal antibodies, for example – are produced in disposable sterile bags containing newly designed single-use sensors to accurately measure pH, dissolved oxygen, and more. With these innovations, costs can come in as low as one-fifth of building a permanent stainless steel vessel batch facility.

For continuous manufacturing, the challenges involve sophisticated process controls. Decision-makers need to be able to review all production variables as an integrated, interdependent system, so that a change in one is met with the right response somewhere else – all while the system continues to operate.

The systems also must provide continuous traceability and record-keeping – preferably digitally – to comply with strict government regulations. This is so challenging that organizations ranging from our company to the Massachusetts Institute of Technology and Purdue University to Johnson & Johnson, Merck, Novartis, and other leading companies are all working on it.

Meanwhile, the Internet of Things is bringing online new technologies and capabilities to increase operational efficiency – by maximizing the ability to predict and thereby prevent equipment failure and by optimizing the manufacturing process.

This capability also enables concentrating those functions across plants, or even to a third party.

Regulatory compliance also will be facilitated by Pharma 4.0.

The good news is we’re moving ahead faster than most observers would have thought possible only a few years ago. As a result, hundreds of millions of more people will soon be able to benefit from the breakthrough therapies science is giving us.

Automation-powered manufacturing behind these therapies won’t make headlines—but they will help give us a better world.

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