LINCOLN, Neb.--(BUSINESS WIRE)--Celerion announced today the multimillion-dollar expansion of specialized pharmacies across their clinical research units in North America, demonstrating their commitment to further assisting sponsors in meeting the forthcoming USP requirements for compounding investigational drug product in support of early phase clinical trial research.
Celerion’s purpose-built, pharmaceutical compounding facilities include a total of seven highly specialized pharmacy suites where investigational formulations are prepared under USP-compliant conditions, including General Chapters <795>, <797>, and <800>. The facilities feature designated compounding suites equipped with systems controlling negative and positive differential air pressure in ISO classified areas, independent HEPA filtered air ventilation systems and equipment, and preparation viewing areas.
Emerging guidelines from the FDA and USP require that investigational products administered in a Phase I clinical research environment be produced to the highest quality standard possible for safe use in humans. As such, Celerion has made a significant investment in the upgrade of the pharmacy suites in the Phoenix and Lincoln clinical pharmacology units.
“Celerion is proud to open these dedicated ISO classified areas for compounding nonhazardous and hazardous drugs for both sterile and non-sterile formulations to further support the needs of our biopharmaceutical clients,” said Phil Bach, vice president, global clinical research at Celerion. “This expansion is well-aligned with our 10-year anniversary, A Decade of Translating Science Into Medicine, exemplifying the scientific focus driving our success.”
“These advances enable our clients to rapidly adjust dosing parameters in an adaptive manner, which in turn enables drug development team decisions to be made more rapidly and drugs to get to patients faster, which is the prime mission of Celerion,” stated Susan Thornton, Ph.D., CEO of Celerion.
Celerion’s Kate Reese, Pharm.D., will share “The Future of Pharmacy: How New U.S. Regulatory Requirements Impact Early Phase Clinical Pharmacology Studies” on June 25 during an upcoming Celerion ScienceSM Webinar. Information regarding drug product requirements in early studies will be included; specifically the differences between cGMP and on-site extemporaneous pharmaceutical compounding will be discussed.
About Celerion Inc.
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 50 years, Celerion has leveraged the latest operational concepts and technologies to execute safety/tolerability, pharmacokinetic, and pharmacodynamics 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. Celerion offers feasibility, 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 families, friends, and people in need around the world. For more information, please visit celerion.com.