Medication Manufacturing is Due for a Revolution

Decentralized drug manufacturing facilities enable streamlined production that can quickly adapt to changing needs, resulting in a faster time-to-market and lower reliance on global supply chains.

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I remember attending a drug development course at UC Berkeley Extension three years ago. The professor pointed out that while most medication manufacturing processes are more than a century old, they wouldn’t be changing anytime soon. His reasoning: precision medication manufacturing is too cost prohibitive.

What he didn’t mention was that antiquated medication manufacturing processes come at a high cost as well. Pharmaceutical companies spend some 25 percent of their revenues on manufacturing, while rejected batches, remanufacturing, and quality control investigations can increase production costs by up to 10 percent.

How Medications are Made

Pharmaceuticals are typically made via batch manufacturing, a process that uses large machinery and involves multiple discrete steps. After each step, manufacturing is halted to test the intermediate, which is either stored or shipped to another facility for completion. This significantly extends processing time and increases the risk of product degradation. The batch manufacturing process is also limited in its scalability – more space and equipment are required to increase output.

In contrast, continuous manufacturing automates the testing of intermediates, allowing drugs to progress through each manufacturing step without halting the process. In addition to reducing the risk of human error, this method decreases overall processing time, which means continuous manufacturing can better respond to changes in demand.

Where Medications are Made

Drug manufacturing capabilities are unevenly distributed throughout the world: there are 5,000 drug manufacturing facilities operating in China and more than twice as many in India. In Africa, there are less than 400 drug manufacturers, so the continent is almost entirely dependent on the global pharmaceutical supply chain: up to 90% of the medications consumed in Africa are imported. This makes African countries extremely vulnerable to supply chain disruptions, which often leads to severe drug shortages and unnecessary deaths. It is estimated that 1.6 million Africans die every year because they cannot access affordable medication.

The Solution: Small-Batch, Hyperlocal, Globally Interconnected Manufacturing

Decentralized drug manufacturing facilities enable streamlined production that can quickly adapt to changing needs, resulting in a faster time-to-market and lower reliance on global supply chains. One of the reasons this model hasn’t yet been implemented is that it is very difficult for these facilities to effectively respond to drug shortages that are already occurring. Recently, many enabling technologies–such as artificial intelligence, machine learning, and the Internet of Things (IoT)–have emerged that can facilitate medication manufacturing in distributed networks, making them more resilient and responsive to emergency situations. In this era of information, drug shortages can be easily reported and tracked, and most importantly, used to predict future shortages, thus enabling truly efficient drug manufacturing that meets the needs of patients, regardless of where they live.

 

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Photo: Chelms Varthoumlien