Features three separate areas for sterile compounding
US drug development services provider Celerion has completed a cleanroom and pharmacist certification to comply with USP <797> guidelines.
The cleanroom includes three separate areas, with one ante-room serving two individual cleanrooms. One cleanroom is a dedicated microtracer area, which contains a Class A2 biological safety cabinet for radiolabelled microtracer compounding. The other cleanroom contains a laminar flow hood for traditional IV compounding. Both cleanrooms are ISO 7 certified, attached to an ISO 8 ante-room and are used for sterile compounding.
The company says the cleanroom area allows in-house preparation for microtracer studies and provides an alternative to GMP manufacturing of the IV solution.
A large number of bioavailability and First-in-Human (FIH) studies require sterile compounding. The USP <797> cleanroom allows for all types of complex compounding for low, medium and high risk investigational compounds.
Celerion can take a client’s API and develop customised dosing and compounding to enable very selective dose levels to be administered. This solution, combined with the company’s expertise in delivering early stage adaptive trial designed studies, enables clients to reach clinical proof-of-concept (PoC) faster.
“When combined with our Lincoln, Nebraska, facility’s radiolabel licence, the cleanroom allows Celerion to offer execution of Phase 0, microtracer and microdosing studies, producing data typically not available until later in drug development,” said Phil Bach, vice president of Clinical Research at Celerion.
Celerion was formed through the acquisition of the early stage development operations of MDS Pharma Services. The company offers clinical research (Phases 0, I and IIa, NDA-enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services.