Accelerating drug discovery and development is a focus for the pharmaceutical industry as it seeks to reduce the cost and time required to advance new drugs through proof of concept to commercialization. This need applies to all drug substances, including small molecule APIs. Quality-by-design (QbD) is a strategy for achieving this goal by building quality into products and processes from the earliest design and development stages, rather than relying on quality control applied after a product is manufactured.
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High-throughput screening (HTS) is not a new concept and has been used in a variety of contexts in the pharmaceutical industry for many years. In addition to generating small amounts of APIs for testing, it is used to evaluate potential molecules during the drug discovery process by investigating a wide range of physical parameters, the propensity for salt formation, and other API characteristics. It is also employed in process development to fully characterize the process design space and identify optimal process conditions.
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Digital transformation of manufacturing is taking place in many industrial sectors. The pharmaceutical industry is no exception, although, given its conservative nature, the pace at which digitalization is occurring in pharma is slower. Even so, a recent Deloitte Center for Health Solutions survey of 60 middle-sized biopharma company leaders in the first half of 2020, and an analysis of investor statements from the largest pharma companies in the last quarter of 2019 and the first quarter of 2020, revealed that maintaining and expanding R&D, technological transformation, and a global market presence are top strategic priorities.[76]
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Prior to the COVID-19 pandemic, increasing numbers of drug developers were leveraging accelerated regulatory approval pathways to bring their products to market more quickly. The rapidity at which the COVID-19 vaccines received approval has since created greater expectations for reduced development timelines.
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As the complexity of small molecule APIs increases, so does the manufacturing complexity. It is estimated that both the average number of chiral centers in small molecule APIs and the average number of steps required to make them have increased by over 60% in the last 20 years.[81]
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