Drug development, from initial discovery of a promising lead compound to the final medication, is a costly, lengthy and incremental process. The ultimate goal is to identify a molecule with the desired effect in the human body and to establish its quality, safety and efficacy for treating patients. The final, approved medication must improve patients’ quality of life, not only by curing their illness, but also by making sure that the cure does not become the cause of other problems or side effects.
For this reason, much time, testing and significant regulatory processes are involved before a drug is commercialized. According to the US Food and Drug Administration (FDA), it takes, on average, 12 years for an experimental drug to progress from bench to market.
Throughout the costly, complex and long drug development and manufacturing process, perhaps the most critical aspect is the development of reaction technologies. In essence, reaction technologies form the secret sauce to all chemistry innovation. This article provides background on reaction technologies and their importance in New Chemical Entity (NCE)/ Active Pharmaceutical Ingredient (API) manufacturing.
Here at PCI Synthesis, we offer a number of reaction technologies that form the basis of many new chemistry innovations, such as alkylations, oxidations, hydrogenations, chiral synthesis and nitrations.
A chemical reaction is simply the process in which one or more substance, or the reactants, are converted to one or more different substances, which become the final product. This occurs when the chemical reaction rearranges the constituent atoms of the reactants to create different substances.
There have been dozens of reaction technologies discovered in organic chemistry and specialized chemists have perfected the techniques to achieve a NCE or API with minimal impurities.
Chemists have classified the many different reactions into general categories, including the following:
When looking for a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) to perform reaction technologies and handle your important projects, make sure you ask key questions such as:
The process of converting raw materials into final products represents the scientific essence of all NCE development. The key to success is to ensure that the chemists handling your project have the expertise, best practices and vision to see your project from initial reaction through to commercialization.
Learn more about our reaction technologies capabilities here, or reach us (978) 462-5555 or firstname.lastname@example.org.