The term contract development and manufacturing organization or CDMO is used in the pharmaceutical industry to designate a company that is in the business of assisting the pharma companies in drug development and manufacturing processes. This is sometimes also known as a contract manufacturing organization (CMO), with both being the same type of entity.
There are many benefits to a pharmaceutical company in choosing a contract development and manufacturing organization to complete the various aspects of the development through to manufacturing and packaging of a specific product. The most obvious is the ability to outsource this work, eliminating the need for the pharmaceutical company to complete the processing on their own. This not only prevents the need for equipment and staffing upgrades and expansions, but it also provides for much easier scalability as the market for a particular medication expands.
Speed to Market
While there are limits as to how quickly any pharmaceutical product can go through the various approvals and clinical trial phases, by working with CDMO aspects of the process can be completed on very tight timelines.
This can be achieved through the expertise, capacity, and focus of these contracted manufacturers. With different departments specializing an analysis and testing, pre-formulation services, formulation development and then through clinical trials, the process will be more efficient than trying to do this in-house or with the use of several different contract manufacturers, each addressing a specific stage in the development.
Options in Dosage Forms
One of the most common reasons to use a contract development and manufacturing organization for even a large and established pharmaceutical company with in-house development and manufacturing options is the ability to test different dosage forms.
Increasingly, consumers, doctors, and regulators are demanding dosage forms that are easier to use and provide greater safety. By working with a CDMO using state-of-the-art testing and analysis methods, specialty dosage forms can be developed that create a market for the product, enhancing immediate as well as future sales.