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In this ongoing series , we put a spotlight on contracts between pharma companies and contractmanufacturing organizations (CMOs). In 2021, the US FDA had decreed that about 60 million doses of the vaccine made at Emergent’s factory be discarded after a batch was contaminated. .
Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.
Over the years, several advanced and innovative automation tools and technologies have been developed; these have been demonstrated to hold the potential for significant reduction in the cost associated with the manufacturing of advanced therapy medicinal products, thereby, making such products more affordable.
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AstraZeneca is shifting production of its COVID-19 vaccine away from a plant in Baltimore which also makes Johnson & Johnson’s shot, after human error resulted in the contamination of 15 million doses. . Emergent claims however that one batch of the vaccine simply failed quality controls, and no contamination took place.
Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. Manufacturing these highly potent and often cytotoxic drugs introduces many risks for operators and the environment. But containment is not only important at commercial-stage manufacturing.
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