Throughout my career in the chemical industry, I’ve been amazed to learn about the transformation of our chemical manufacturing processes through digital technology innovations. What used to be the manual loading of dangerous chemicals at imprecise levels has shifted to charging precisely measured raw materials with the push of a button. Quality testing that historically required manual sampling and testing has been replaced with in-process sensors that can report on many metrics continuously throughout processing.
Although the internet-of-things has enabled well-established operations for the continuous flow manufacturing of chemicals, the pharmaceutical industry’s adoption of continuous manufacturing over the same time period was limited by technological immaturity1. In the highly regulated pharmaceutical industry where safety is of utmost importance, and where healthcare payers are imposing cost constraints, adopting digital technologies could lend itself to improving real-time quality control throughout the supply chain and reductions in costs.
According to BioPharm International, “the Food and Drug Administration (FDA) has been a strong supporter of continuous processing as early as 20041”, with the FDA reporting opportunities for achieving consistent quality, lower costs, and increased productivity2. Advancements in technology, regulatory support and competitive pressures are advancing the industry forward. Johnson & Johnson (J&J) is the first to receive FDA approval for switching from batch to continuous flow manufacturing, utilizing sensors within the production equipment to continuously monitor product quality, ultimately driving to make every pill exactly right (3). Further down the supply chain, J&J continues to monitor the product between processing and the consumer, utilizing in-product sensors to monitor temperature-sensitive medicines4. For the longer-term, J&J is taking the supply chain a step further, exploring the opportunity to continue monitoring their products once inside the human body4.
Given varying production requirements and demand across drugs, I imagine that not all drugs will be manufactured via continuous flow; however, I forsee that big data collected from these processes can prove valuable for other drugs, and recommend that Johnson & Johnson extrapolate insights that they can apply to improve the quality and safety of batch-manufactured drugs. As more data is collected, I can’t help but wonder whether pharmaceutical companies will find themselves better positioned to commercialize products faster. Backed by their capabilities to control variability in the final product, will they will be able to prove the efficacy of drugs in a more controlled way?
1Hernandez, Randi. “Continuous Manufacturing: A Changing Processing Paradigm.” BioPharm International. N.p., 10 Nov. 2017. Web. 14 Nov. 2017. <http://www.biopharminternational.com/continuous-manufacturing-changing-processing-paradigm>.
2Chatterjee, Sharmista. “FDA Perspective on Continuous Manufacturing.” The Food and Drug Administration. Proc. of IFPAC Annual Meeting, Baltimore. N.p., Jan. 2012. Web. 14 Nov. 2017. https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM341197.pdf
3O’Marah, Kevin. “Smart Manufacturing Is Ready to Take Off.” Forbes. Forbes, 06 Oct. 2016. Web. 14 Nov. 2017. <https://www.forbes.com/sites/kevinomarah/2016/10/06/iot-and-supply-chain-precision/2/#55f461214233>.
4Blanchard, Dave. “The Healing Power of the IoT.” IndustryWeek. N.p., 16 May 2017. Web. 15 Nov. 2017. <http://www.industryweek.com/supply-chain/healing-power-iot>.
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