Conflicts and opportunities in the Life of APIs

摘要

Consumers would like to have drugs that are of consistent quality and at the lowest price. However, with Pharma's current business model considerable effort is needed to maintain product quality and there are conflicts. Focus of the current pharma business model is invent a new molecule, commercialize and abandon i.e. let the generics take over when the patent expires. Due to less than efficient manufacturing technologies considerable effort is needed to maintain quality and comply with regulatory requirements. Even with this effort companies come short as evident by recent recalls and consent decrees. Making a grass root change in process development and manufacturing practices can easily eliminate these conflicts. One has to understand and exploit physical and chemical behavior of chemicals (sociochemicology) of the chemicals involved and produced in the manufacture of active ingredients. Creative application of unit processes and operations is equally important. Such processes not will produce quality product but will have lower manufacturing cost (higher profit), will be safe and sustainable.