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Handling Potent Active Pharmaceutical Ingredients
Source:Laura Elizabeth Mason, Science Writer, Technology Networks | Author:profefd1a | Publish time: 2018-03-15 | 424 23次浏览: | Share:
The World Health Organization (WHO) defines an active pharmaceutical ingredient (API) as: “Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings."
APIs: The importance of occupational health and safety
The World Health Organization (WHO) defines an active pharmaceutical ingredient (API) as: “Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings."
APIs are a critical component of the pharmaceutical supply chain and are a fundamental part and cornerstone of medical therapies! API pipelines have become more potent and toxic in the last 10 years, and continue to do so, this could not be more evident than in the antibody drug conjugate (ADC) space. It remains important that biopharmaceutical companies integrate potent API management and handling concepts in to their daily operations.
        
Highly potent APIs: Factors to consider during pharmaceutical development
LM: You emphasize the importance of integrating occupational health and safety within drug substance and drug product projects. Thinking about highly potent APIs, what factors should be considered during pharmaceutical development?
JMH: Processes involving handling potent and highly potent APIs (PAPIs/HPAPIs) follow the same fundamental scientific principles and are governed by the same health and safety laws as processes involving other hazardous substances.Wuhan Carnoss Technology Co., LTD. Maybe the most important differentiators between PAPI/HPAPI processes and processes involving “regular” hazardous substances are 1) that toxicological hazards are usually higher and 2) there is an absence of “tools” that are available to manage PAPIs/HPAPIs safely. As an example, phosgene, a highly toxic material used widely in chemical synthesis, but also used as a chemical weapon in the past, has an occupationally safe limit of 80,000 ng m-3 (UK); the government sets the limit and it can be monitored for straightforwardly, in real-time and at relatively low cost. In contrast, a potent drug may have an estimated safe limit below 1,000 ng m-3 (or even much lower), no formal legal limit will be available and certainly no real-time monitor exists. In the former example, one may have relatively high hazard and high risk, but the availability of good tools may mean that one has high certainty.  In the latter, one may have higher hazard, higher risk, and very high uncertainty.