Radiotracers are essential tools in nuclear medicine, used for diagnosing and monitoring a variety of diseases, including cancer, brain and heart conditions. However, their production is highly specialized, time-sensitive, and regulated due to the use of radioactive materials with short half-lives e.g. (Ga68, 68 minutes and F18, 109 minutes). This makes traditional centralized manufacturing model impractical. Contract Development and Manufacturing Organizations (CDMOs) play a vital role in overcoming this issue by providing the manufacturing capabilities needed to produce and deliver radiotracers in multiple geographic regions close to desired end-users (hospitals, imaging centers).
Following is a list of important items to look for in a potential CDMO partner:
- GMP-Compliant Facility with the expertise for making the type of radiotracer desired
- Access to Isotopes or on-site Cyclotron
- Reliable Supply Chain and Backup Systems for raw materials and backup plans in case of equipment failure or delays, to ensure continuous supply.
- Experienced Team members to manufacture, test and distribute the type of radiotracer needed.
- Redundancy: Available manufacturing capacity to supply radiotracer dosages in case of batch failures
- Proximity to end users for fast delivery
- Scalable Operations for higher demand
There are several CDMO partners with the expertise, flexibility, and reliability to deliver quality products safely and on time.
