April 21, 2010
In this final installment of the series on Drug Development, we examine stage 4 and the effort involved in Drug Manufacturing and Process. The 4th stage begins with a large scale production of the new drug, followed by formulation studies and then ending with regulatory reviews of the entire process before the drug can be marketed and sold.
The new drug is batched produced through a scale-up synthesis of the active drug component. At this point, new impurities may surface and thus warrant further investigations into its toxicity effects. Each impurity must be identified, elucidated, re-synthesized and re-tested to ensure all safety precautions were taken.
On the formulation side, further studies are done to ensure that the active drug ingredient and its impurities are combined with an excipient that is compatible and that the dosage upon intake is consistent. In addition, stress tests are performed on the mixture to check for any harmful degradation products that may occur during storage. These studies tend to overlap with the Drug Trials set in stage 3.
For good measures, all the analyses and tests are scrutinized by a team of internal and external experts. They verify that all the correct procedures were applied and the data is consistent with what is intended to be sold.