An accomplished regulatory consultant with more than two decades of experience working at pharmaceutical and biotechnology companies, Robert Gadimian leads Perspective Regulatory Consulting as president. In this position, Robert Gadimian is responsible for guiding the development team in terms of the regulatory requirements for the development of new drugs.
During the manufacturing process of drugs, there are chances that potential genotoxic (DNA-damaging) compounds are added to the synthetic reaction in the initial phase or formed subsequently as potential genotoxic impurities (PGI). This is a common issue with the manufacturing of drugs that are based on small molecules. To counter PGI issues, almost all companies involved in the manufacturing of small-molecule compounds run tests to check for potentially genotoxic impurities. If the drug in question is designed to treat a life-threatening disease or the patients who are to use the drugs are not expected to live more than five years, PGI is of less consequence and requires less attention.
The main reason for evaluating PGI risk is to mitigate the chances of developing cancer as a result of consuming genotoxic impurities along with medication over a long period of time. Since patients with life-threatening diseases are much less likely to consume the drug for a long time, their chances of developing cancer from genotoxic impurities are significantly lower. In addition, some of the patients are already cancer patients, which makes the genotoxic impurities incapable of causing a new cancer.