4 Questions to Ask Prospective CMOs about Reaction Technologies

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:

• A synthesis reaction: In which two or more substances combine to form a new compound.
• A single replacement reaction: In which one element replaces a similar element in the compound.
• A double replacement reaction: In which the ions of two compounds exchange places in a solution to form two new compounds.
• A decomposition reaction: In which a single compound undergoes a reaction that produces two or more simpler substances. The transformation of water into oxygen or hydrogen is an example of this reaction technology.
• A combustion reaction: In which a substance combined with oxygen, releasing a large amount of energy in the form of light and heat.

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:

• How experienced are your chemists? Experienced chemists are important in the creation of sound reaction technologies, and developing the synthetic route and process chemistry. Not only have they perfected various reaction technologies, but can they anticipate any problems that could arise during scale-up and mitigate those problems in earlier stages.
• Do you use the same team throughout the entire project? It’s important that the chemists working on your team can handle everything –from process R&D through scale-up and bulk manufacturing.  All members of this team should also have expertise in chemistry and engineering and be actively involved from project launch through completion.
• Does the team conduct continuous reviews? The CMO you select should be able to respond rapidly to your needs and conduct continuous reviews of analytical and process data to improve processes wherever possible.
• How many reaction technologies have you developed? While every project is different, there are many elements of a project that can apply to other projects, so a CMO’s library of best practices and reaction technologies can often provide a major leg up for your project. In addition, the more reaction technologies the CMO has experience with, the more knowledge it has to ensure that the final product has the highest purity possible within its control.

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  info@pcisynthesis.com.

About the Author

Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.