LINCOLN, Neb.--(BUSINESS WIRE)--Celerion, a leading clinical research organization specializing in early clinical research and bioanalytical services, announces the launch of on-site services for rapid sterility testing (validated alternative method to USP <71>) and dose formulation analysis.
Per FDA guidance, pharmaceutical products intended for parenteral administration must undergo sterility testing and provide results that meet stringent safety standards before reaching patients. Additionally, laboratory testing of Phase 1 investigational drugs must be completed to evaluate quality attributes including identity, strength, potency, and purity. Celerion’s comprehensive approach includes a fully integrated pharmacy and analytical laboratory facility.
Celerion’s on-site pharmacy allows for “just in time” flexible formulation, saving clients time and money. Leveraging state-of-the-art equipment and expert analysis, Celerion refines pharmaceutical dosage formulations efficiently and effectively. This enables seamless compound analysis and testing, optimizing efficiency, speed, and control throughout development and testing phases.
“Offering comprehensive analysis and testing capabilities under one roof provides sponsors with rapid, reliable solutions that meet regulatory requirements without compromising quality,” said Chad Briscoe, Ph.D., Executive Vice President, Global Bioanalytical Sciences.
“In the face of evolving regulations, timely access to accurate sterility test results is paramount,” said Phil Bach, Executive Vice President, Global Clinical Research. “Our in-house capabilities for sterility testing and analysis allow us to accelerate this critical step within our controlled environment, providing sponsors with unparalleled speed and development schedule oversight.”
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. For more information, please visit www.celerion.com.
