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According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contractmanufacturing organisations (CMOs) to acquire facilities. Download the whitepaper below to find out more about ILC Dover’s flexible solutions for protecting the entire supply chain.
Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. This adds to costs and places higher demands on PPE due to risks of exposure: “Production is more costly.
Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. In this ongoing series , we put a spotlight on contracts between pharma companies and contractmanufacturing organizations (CMOs). Covid-19 vaccines stay in the spotlight.
Further, the manufacturing of biologics fill finish is a highly complex and cost-intensive process. For instance, small biotech companies enter into agreements with fill finish manufacturing companies due to lack of in-house capacity.
Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.
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.
MultiStem ® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. About MultiStem ®.
MultiStem ® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. About MultiStem ®.
Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. This guidance may be adjusted in the future as additional contracts are executed. Hospital products, which grew 10% operationally to $2.3
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.
According to GlobalData’s Drugs database, 97% of marketed drugs are small molecule products and analysis shows an increased CMO appetite for specialized capabilities, with controlled substance and containment facilities highly sought after [i].
The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment. Once set up and validated, the control process must guarantee constancy during production so that the results are as expected.
– about the advantages and challenges of product lyophilization, developing lyophilization processes on site at their Bloomington, Indiana plant, and the importance of continuing research. Biologics often have strict temperature requirements to ensure the product remains stable. KB: Primarily stability.
Manufacturing these highly potent and often cytotoxic drugs introduces many risks for operators and the environment. Cross-contamination of standard products with highly potent ones is another key concern. Between 2018 and 2020, 58% of the small molecule API contractmanufacturing sites purchased worldwide offered containment.
The FDA’s closeout letter refers specifically to the cross-contamination incident that led to 15 million doses of the J&J shot being jettisoned when ingredients destined for AstraZeneca’s AZD1222 shot were accidentally mixed into vials of the J&J product.
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