Celerion Expands Early Phase Clinical Pharmacology Units

Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, has announced completion of additions to its research capacity and services. This includes the opening of a new Screening and Return Center, upgraded pharmacy compounding suites, expanded Absorption, Distribution, Metabolism and Excretion (ADME) laboratory capacity and fifty additional beds.

“The industry’s critical need for early phase clinical research continues to validate our aggressive expansion strategy,” says Phil Bach, Celerion’s Vice President of Global Clinical Research. “These latest facility upgrades provide a timely boost to our overall clinical capacity, capabilities, and start up timelines even beyond the unique needs generated by a global pandemic.”

The new 40,000 square foot facility adjacent to the Phoenix, Arizona (AZ) clinic is designed to increase screening capacity and cater to the participant experience. It allows Celerion to better segregate ongoing in-house clinical trials and outpatient visits and screening to increase throughput and volume.

The addition of fifty new beds increases the total bed capacity to 350 at their Phoenix, AZ Clinical Pharmacology Unit, and brings Celerion’s total global bed count to over 650 beds. These additional units are designed for complex Phase I protocols including first-in-human, intense cardiac monitoring, Thorough QT studies and unique biomarker collections and procedures. What’s more, this adds increased capacity to Celerion’s core clinical pharmacology studies such as drug-drug interaction, bioavailability and bioequivalence studies.

“Multi-million dollar expansions of Celerion’s Lincoln, Nebraska (NE) and Phoenix, AZ pharmacies were also made to include a USP <797> compliant clean room and individual suites that are US <795> and <800> compliant for complex extemporaneous compounding of sterile and non-sterile investigational products. The expanded pharmacy capabilities offer clients a quick and cost-effective way to start clinical trials, without the need for extensive CMC investment in the early stage of development. Dose preparations are made in “real time,” enabling clients to make seamless adjustments to the dose or formulation and to respond quickly to changes in the first-in-human protocol design. All of this can deliver an accelerated timeline without the need for clients to have to work with multiple vendors.”

Bach adds that doubling the ADME Lab capacity in Lincoln, NE gives clients additional flexibility in scheduling human mass balance studies. Celerion has invested in new state-of-the-art equipment and laboratory space to expand on-site scintillation counting, allowing for radioactivity recovery results to be delivered in real time. The on-site laboratory and Phase I clinical facilities offer seamless integration of services and data, he says.

“Combined with our vast experience in delivering early-stage clinical pharmacology studies, these solutions allow clients to reach clinical proof-of-concept faster,” Bach adds.

About Celerion

Celerion, a global leader in early clinical research services, offers a unique combination of medical expertise, clinical operations experience, and scientific excellence that gives its clients the confidence to make fast, accurate decisions about their drug development path.

For over fifty years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamic studies in highly controlled clinical environments. These include first-in-human dose escalation, drug-drug interaction, cardiac safety, bioequivalence and bioavailability, metabolism and excretion studies, as well as pharmacokinetic evaluations in patients with impaired renal or hepatic function. In addition, Celerion offers data management, biostatistics, clinical monitoring, and bioanalytical services. Our founding mission is to help our clients get their drugs to market quickly, so that they touch the lives of our family, friends and people in need around the world.