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Continuous Epiphany for Pharma
Posted on April 18th, 2016 by Ken Klapproth in Chemical Manufacturing ExcellenceIs it the FDA or the drug manufacturers who are late to the party for continuous manufacturing?
Reading an article on how the FDA is urging drug companies to adopt continuous manufacturing, it struck me as odd that the methodology would be positioned “new” and that they were lauding companies such as Johnson & Johnson’s Janssen drug unit for pioneering work in this approach. Don’t get me wrong, using continuous manufacturing can absolutely produce substantial benefits in throughput, safety and quality, but it hardly qualifies as “new”. After all, “continuous” or progressive manufacturing techniques have been in use for centuries, tracing roots to the Venetian Arsenal, the Industrial Revolution, or even the Ford Model T assembly line.
Following the article to its genesis on the FDA’s blog, Lawrence Yu, Ph.D writes about the novelty of continuous manufacturing for drug companies, describing it as “a new and exciting technology” replacing the batch processing being used for the last 50 years or so. Once again, I couldn’t disagree with the premise of Dr. Yu’s argument, but still didn’t understand the positioning as “new”. Curious to know what I was missing, I immediately turned to the oracle of our time – YouTube:
Effectively, the approach is an assembly line enabling drug companies to produce drugs continuously from powder to tablet. Automating the process certainly fits the best practices of lean manufacturing and Kaizen and encompassing the process in one self-contained unit eliminates wait processes – a fundamental tenant of Six Sigma.
As my father used to say, “It doesn’t matter when the light turns on, as long as it does.” While the concepts of continuous manufacturing have been around for years in other industries, it’s good to have drug companies on the bandwagon. As a consumer, I look forward to the benefits in quality and efficiency this process can bring to the industry and – hopefully – the benefits of safety and lower cost it can personally mean to me.
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