Pharmaceutical Technology - October 2021


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12 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m APIs T he advantages that enzymes have as biocatalysts are well known within the pharmaceutical manufacturing industry, not least that they can give excellent specificity and yields, and even facilitate reactions that are difficult with chemi- cal catalysts. Their credentials towards improving sustainability are also increasing the levels of interest for process development, as biocatalytic reactions can be more efficient in terms of solvent and material use. The efficacy of some enzymes can be very high. For example, the en- zyme carbonic anhydrase has been shown to catalyze the hydration of 4 million molecules of carbon dioxide per second, which is near the limit of turnover dictated by diffusion. While this is an extreme case, a well- chosen enzyme should be able to give a high yield in a short time. Humans have long benefitted from biocatalytic reactions—despite not understanding the scientific processes—with yeasts reportedly being used in brewing about 8000 years ago. It was not until the 1830s, however, that the source of the reaction was determined by chemists in a French sugar factory, when they isolated the enzyme diastase. It was another 60 years before the German chemist, Eduard Buchner, showed that enzymes could be used as chemical catalysts without cells, and it was for this work that he was awarded the Nobel Prize in Chemistry in 1907. Thousands of enzymes that catalyze chemical reactions are now known, and significant technological advances since Buchner's day have made it easier to find an appropriate enzyme catalyst for a specific reaction. Catalysts can be designed to make novel enzymes that efficiently cata- lyze reactions where natural enzymes cannot. The growth in industrial application is significant: the global market for biocatalysts is expected to grow by about 15% between 2019–2024 (1), reaching $10 billion (2). Seeking Economies of Scale for Biocatalysis Mark Muldowney and Greg Holgate New enzymes and protein engineering have advanced biocatalysis processing toward commercial acceptance. Technology and economic roadblocks must be overcome for the process to be widely embraced by pharma. Mark Muldowney is head of technology, and innovation and Greg Holgate is biocatalysis chemist, both with Sterling Pharma Solutions. SERGEY YAROCHKIN - STOCK.ADOBE.COM

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