8 TECH OUTLOOKNovember - 2021Impact of Advanced Manufacturing Technologies on the Pharmaceutical Industry In September 2017, Hurricane Maria devastated the island of Puerto Rico (PR). In addition to creating public health and humanitarian crises in PR, Maria's impact was felt worldwide when it left an acute shortage of essential drugs in its wake. The island is home to 49 FDA-approved pharmaceutical manufacturing sites and is an essential part of the global drug supply chain. Many thought that this supply disruption was a once-in-a-century event, only to find themselves amid a worldwide pandemic just 30 months later. Given the dependency of many nations on the complex and fragmented global supply chain for medicines, several countries are now concerned about their domestic supply of medicines should another disruption occur. It is clear that diversification of the drug supply chain is needed, but it will not be easily achieved using only the traditional batch-based manufacturing approaches. Advanced manufacturing, which involves the usage of new modalities such as Continuous Manufacturing is changing the way the world produces lifesaving medical products. Focus on Advanced Manufacturing Technologies (AMT) AMT is a term used to refer to several technologies, and the most prevalent amongst them today is Continuous Manufacturing (CM) of pharmaceuticals. In contrast to traditional batch-based manufacturing, which involves large quantities of material being handled and transformed all at once, CM refers to a process in which the product is continuously harvested over time while simultaneously feeding the ingredients into the manufacturing line. While this paradigm is not new to industries such as petrochemicals, its adoption in the pharmaceutical industry is only beginning to take off, as a handful of IN MY OPINIONBy Atul Dubey, Director, Pharmaceutical Continuous Manufacturing, US PharmacopeiaAtul Dubey
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