Celerion Adds USP 797-Compliant Clean Room, Enabling Execution of Microtracer and Microdosing Studies

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Company News Release


announces the completion of a Clean Room and pharmacist certification to comply with USP 797 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 clients a one-stop option thereby saving time and money.
A large number of bioavailability and First-in-Human (FIH) studies require sterile compounding. The USP 797 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 addition of the USP 797 Clean Room continues to demonstrate Celerion’s commitment to implement innovative solutions to generate critical data to enable decisions in drug development to be made earlier,” said Phil Bach, Vice President of Clinical Research at Celerion. “The clean room when combined with our Lincoln, Nebraska, 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.”
The 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.