TECH OUTLOOKTECH OUTLOOKDECEMBER - 20209approval. CM is relatively new to the block, however, as is evident by several approved cases, the current regulatory framework is sufficient to gain approval. 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 to CM.Adopting CM requires investments into 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 AMTAs an independent, science-based non-profit organization working globally, USP has a unique role to play both in the developed as well as the low- and middle-income countries (LMICs).USP has identified several of it's existing standards applicable to CM as well as explored opportunities to develop new standards for materials, characterization, models, and digital methodologies essential for successful implementation of AMT.These, alongside USP's unique capability building initiatives for the industry, it's advocacy for regulatory policies, and incentives constitute a well rounded and timely intervention.In collaboration with leading academic R&D centers, USP is developing 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 manufacturing world.AMT and its impact on pharmaceutical manufacturingAs 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, is developing digital twins of API manufacturing processes and is finding ways to leverage the success of AMT with a few branded products to expand into generics, industries such as catalyst,nutraceuticals, cosmetics, and foods.It is important that regulatory and government incentives are provided to initiate adoption of AMTs. USP can 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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