Celerion uniquely offers a USP -compliant Clean Room as part of our Phase I core capabilities. Our onsite pharmacists have also been certified to meet USP guidelines.
This enables in-house preparation for microtracer studies providing an alternative to the requirement for GMP manufacturing of the IV solution. The sterile preparation and administration allows a one-stop option for our clients, thereby saving time and money.
A large number of bioavailability and First-in-Human (FIH) studies require sterile compounding. The USP Clean Room allows for all types of complex extemporaneous compounding for low, medium and high risk investigational compounds. This allows Celerion to take a client’s API, develop customized dosing and compounding that enable very selective dose levels to be administered. This solution combined with our experience in delivering early stage adaptive trial designed studies will allow clients to reach clinical proof-of-concept (PoC) faster.
The unique design of this Clean Room includes three separate areas, one ante-room that serves two individual clean rooms. One clean room is a dedicated microtracer area which contains a Class A2 Biological Safety Cabinet for radiolabeled microtracer compounding. An additional clean room contains a laminar flow hood for traditional IV compounding. Both clean rooms are ISO 7, attached to an ISO 8 ante-room and are used for sterile compounding.
The clean room when combined with our Lincoln, NE, facility’s radiolabel license, allows Celerion to offer execution of Phase 0, microtracer and microdosing studies producing data typically not available until later in drug development.