The Role Of The Contract Development And Manufacturing Organization
In the pharmaceutical industry, the contract development and manufacturing organization (CDMO) hired by the drug developer is critical to all aspects of getting the medication from concept through to approval and production. Sometimes also known as a contract manufacturing organization, these companies focus in on the details of preformulation to through actual manufacturing and packaging for distribution.
The role of the contract development and manufacturing organization will vary based on the specific needs of the pharmaceutical company as well as the capacity of the contract manufacturing organization. There are many advantages for a pharmaceutical to choose a more comprehensive CDMO as this becomes a single contractor that handles the full scope of services from the clinical phase of drug product development through the entire clinical trail steps and process.
What to Consider
For any pharmaceutical, the key factor in choosing a contract development and manufacturing organization will be the level of expertise, experience and proven reliability they offer.
CDMOs that are established and offer specialized teams of experts in the pre-formulation, formulation, analytics, and development as well as manufacturing aspects of bringing a new drug to market are ideal for pharmaceutical companies. With a proven track record and recognized experts on staff, these CDMOs can work independently of the drug company, freeing up in-house staff to focus on their areas of expertise.
Top CDMOs also experience in international drug development requirements. More than ever this is an important aspect of the pharmaceutical industry, and working with companies that are within the United States and have this experience is a plus for drug companies.
Cost of the service will always be a consideration when using a CDMO. However, using a third-party CDMO is much more cost effective for the pharmaceutical company than trying to complete all these phases in-house.