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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.
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).
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 costs and time to the processes involved.
Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.
This precaution is taken to prevent any potentially harmful contaminant from escaping the production area. This is in contrast to the containment requirements at manufacturing facilities of traditional APIs. Various large scale drug manufacturing companies have installed in-house high potency manufacturing capabilities.
The letter also stated that the company’s response to the inspection report was “inadequate because it did not include a review of environmental monitoring data in your manufacturing areas, an adequate risk analysis of previously manufactured drug product, or testing of reserve samples from impacted batches.” Dextrum Laboratories Inc.
Efforts to introduce automation technologies in cell therapies manufacturing are underway, and if implemented successfully, can significantly help in the elimination of human intervention and reduce the risk of contamination.
The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements: our ability to raise capital to fund our operations, including but not limited to, (..)
The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements: our ability to raise capital to fund our operations, including but not limited to, (..)
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.
billion, primarily driven by Pfizer CentreOne, Pfizer’s contractmanufacturing operation, reflecting sales of legacy Upjohn products to Viatris (4) and remdesivir to Gilead Sciences Inc., Hospital products, which grew 10% operationally to $2.3 down 7%, which reflects relatively stable U.S.
Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination. GlobalData’s Contract Small Molecule API Manufacturing Industry by the Numbers (2021) analyzed 2,787 small molecule API contractmanufacturing facilities.
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. This prevents contamination of the elements by the sampled powder.
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.
Risks for cross-contamination when handling cytotoxic and non-cytotoxic products in the same facility must be properly assessed, using state-of-the-art organisation procedures, technical standards, and current industry guidance. United Kingdom. United States. Afghanistan. Åland Islands. American Samoa. Antarctica. Antigua and Barbuda.
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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