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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. Flexible containment solutions for potent APIs. Partnering with containment experts.
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. Many companies are now prioritising investments in containment systems, GlobalData research shows.
This, coupled with small pharma companies being unable to acquire or access containment capabilities in-house, means that the demand for innovative specialized small molecule capabilities remains high. Premium specialized equipment is necessary because high containment facilities call for the separation of the operator from the product.
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 suggests a move towards high-value specialised manufacturing. Containment challenges.
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. Currently mostly outsourced, there are signs that CMOs are beginning to make investments in containment capabilities, to capture emerging opportunities.
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.
Considerations of Handling High Potency Active Pharmaceutical Ingredients HPAPIs have difficult handling requirements which require various measures to be taken into consideration such as primary containment measures and secondary containment solutions. Secondary containment strategy include personnel training and awareness programs.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization.
KB: Some formulations contain low concentrations of the active ingredient. 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.
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.
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., DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of May 4, 2021.
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