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According to GlobalData analysis, specialist small molecule API capabilities such as containment or controlled substances are driving large contract manufacturing organisations (CMOs) to acquire facilities. Flexible containment solutions for potent APIs. Partnering with containment experts.
This heightens the risk of cross contamination, requiring effective containment solutions, especially when handling highly potent powders. These include extraction support systems, single-use liquid bags, ArmorFlex Films, continuous liners, contained powder transfer systems, bag in/bag out systems, and drum liners.
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. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs. Containment challenges.
Berkeley — An estimated 370,000 Californians rely on drinking water that may contain high levels of arsenic, nitrate or hexavalent chromium, and contaminated drinking water disproportionately impact communities of color in the state, finds a new analysis led by researchers at the University of California, Berkeley, and the University of California, (..)
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials. Why Does the IBC Need to do a Risk Assessment?
The expanding production of high potency APIs, along with the increase in associated toxicities, are driving requirements for more effective containment solutions and much-needed guidelines to ensure worker safety. Assess engineeringcontainment controls, from isolators and barriers to fully automated lines.
Due to the infrastructure available for processing, freezing and storing of these container systems, blood bags are the preferred container for cell therapy biopreservation. The above figure presents a general overview of the cryopreservation process.
There is still no data available,” said study researcher Liwen Xiao, an assistant professor of civil, structural and environmental engineering at Trinity College Dublin in Ireland.
Prepare infant formula in a non-plastic container, then transfer it into a baby bottle after it has cooled to room temperature.
Incident Response: Establishing a plan for responding to cybersecurity incidents, including detection, containment, eradication, and recovery. What are Human Factors Engineering (HFE) and Usability Engineering (UE), and why are they important in medical device design?
link] New Product Introduction (NPI) and Technical Transfer (TT) As drug products containing highly potent APIs (HPAPIs) become more prevalent, a robust approach to TT and NPI is essential. The lack of standardized guidelines for NPI and TT further complicates these tasks, making meticulous planning and robust process controls essential.
“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Continuing trends suggest the worst may be over provided the outbreak is contained over the next few months. Taiwan was probably the most effective country overall at containing COVID-19, counting all of 429 infections and 6 deaths from COVID-19 as of last week.
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