TECH OUTLOOK 8DECEMBER - 2020IN MY OPINIONBy Atul Dubey, Director, Pharmaceutical Continuous Manufacturing, US PharmacopeiaImpact of Advanced Manufacturing Technologies on the Pharmaceutical IndustryIn September 2017, Hurricane Maria devastated the island of Puerto Rico. In addition to creating a public health and humanitarian crisis 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 forty-nine FDA approved pharmaceutical manufacturing sites and is an essential part of the global drug supply chain. Many thought that this supply disruptionwas a once-in-a-century event, only to find themselves amid a worldwide pandemic just thirty months later. Given the dependency of many nations on the complex and fragmented global supply chain for medicines, several countries are now concernedabout their domestic supply of medicines should another disruption occur. It is clear that diversification of thedrug supply chain is needed, but it is not going to be easily achieved using only the traditional manufacturing approaches. Focus on Advanced Manufacturing Technologies (AMT)AMT is a term used to refer to several technologies, and the most prominent of them today is Continuous Manufacturing (CM) of pharmaceuticals. In contrast to traditional batchbased manufacturing which involves large quantities of material to be handled and transformed at once, CM refers to a process in which the product is continuously harvested over time while simultaneously feeding the ingredients into the manufacturing train. While this paradigm is not new to industries such as petrochemicals, its adoption in the pharmaceutical industry isjust now increasing with a handful ofinnovator drug products having received regulatory approval.CM is applicable to the manufacture of traditional small molecule medicines made through chemical routes as well as newer biologicsproduced using living cells and can be utilized separately to manufacture active pharmaceutical ingredients (APIs), finished dosage forms (FDFs),or in an end-to-end integrated manner (from raw materials to FDF with API being synthesized along the way). The key potential benefits of CM are better process insight due to real-time monitoring using sensors, advanced process control, ability to divert out-of-specification material in real time, significantly smaller facility size, lower costs of utilities, higher efficiency, and environment friendliness. On the downside, it requires new equipment such as feeders, continuous mixers, spectroscopic tools for in-line measurementsas well as sophisticated control systems.The generics manufacturing challengeWith about 90% of prescriptions in the U.S. being generic medicines, and with that percentage being larger for some other countries--it is clear that the AMT's largest benefit to global public health will be realized only with greater adoption by generics manufacturers. However, there are several barriers to this. The pharmaceutical industryis highly regulated to ensure the safety and well-being of patients, and any significant change to the manufacturing process must receive regulatory
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