TECH OUTLOOKNovember - 20219innovative drug products have received regulatory approval. CM is applicable to the manufacturing of small molecule medicines made through chemical synthesis routes as well as biologics produced using living cells. CM can be utilized 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 that it facilitates gaining better process insight due to real-time monitoring, advanced process control, and the ability to divert out-of-specification material in real-time. It further allows for significantly smaller facility size, lower costs of utilities, high efficiency, and environmental sustainability. On the downside, it requires new equipment such as feeders, continuous mixers, spectroscopic tools for in-line measurements, and sophisticated control systems. The generics manufacturing challenge Several new as well as established generics manufacturers are beginning to implement CM for their products. AMT's largest benefit to global public health will be realized through wider adoption by generics manufacturers. However, there are several barriers to this. The pharmaceutical industry is highly regulated to ensure the safety and well-being of patients, and any major change to the manufacturing process must receive regulatory approval. While CM is relatively new to the block, it is evident, given several approvals pf CM drug products, that the current regulatory framework is sufficiently robust to ensure CM products and processes are properly vetted. What is lacking is a clear understanding of the technology and the associated regulatory requirements that the manufacturers must meet in order to convert from batch manufacturing to CM. Adopting CM requires investments in new equipment, workforce recruitment, and training, as well as the time and material required for fresh process development. USP's efforts to increase access to quality medications via AMT As an independent, science-based non-profit organization working globally, USP has a unique role to play both in developed economies, as well as in economies in transition and developing economies. USP has identified several of its existing standards as particularly applicable to CM and is exploring opportunities to develop new standards for materials, characterization, models, and digital methodologies essential for successful implementation of AMT. Alongside these, USP's unique capability building initiatives for the industry, its advocacy for regulatory policies, manufacturer support and consulting collectively constitute a well-rounded intervention. In collaboration with leading academic R&D centers, USP provides a comprehensive introductory course for industry as well as the regulatory workforce worldwide with the aim of filling the knowledge gaps about CM. To demonstrate how to switch from a batch to CM approach, USP selected one of the top ten prescribed lifesaving generic medicines and, in partnership with a contract research organization, developed a CM process for its manufacture. The knowledge developed from this and other similar studies will be disseminated for the benefit of the pharmaceutical industry. Furthermore, USP is developing a dedicated facility in Richmond, VA, to develop analytical methods for several generic APIs using AMT. PharmaTech Associates, a USP company, provides end-to-end consulting services to the pharmaceutical industry helping with compliance, product and process development, regulatory filing as well as facilities engineering. AMT and its impact on pharmaceutical manufacturing As the manufacturing world makes big leaps forward with Industry 4.0 and the associated concepts of digital twins, machine learning, big data, and analytics, the pharmaceutical industry has not been untouched. Today the industry is speaking about Pharma 4.0, developing digital twins of API manufacturing processes, and finding a way to leverage the success of AMT with a few branded products to expand into generics, industries such as catalysts, nutraceuticals, cosmetics, and foods. It is important that regulatory and government incentives are provided to help initiate adoption of AMTs. USP can help convene such discussion groups and facilitate these initiatives. As advances are made in technologies for real-time sensing, automated controls, artificial intelligence, 3D printing, and hand-held material characterization technologies, we will see more robust, small-footprint factories producing high quality pharmaceutical products closer to the point of consumption. A paradigm shift is happening -- in the way we manufacture, market, and consume pharmaceuticals.
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