Celerion Expands Its Service Offering to Include GLP/GCP Compliant Molecular and Cell Biology Testing
LINCOLN, Neb.; Nov. 10, 2022 (Business Wire) – Celerion, a clinical research organization (CRO) to the biopharmaceutical industry, announces the expansion of molecular and cellular capabilities to Good Laboratory Practice/Good Clinical Practice (GLP/GCP) standards to support the development of new modality therapies, such as cell and gene therapies. The expanded service offering is available in both of the company’s Lincoln and Zürich bioanalytical laboratories and includes ELISpot analysis, flow cytometry, and qPCR.
Celerion’s expanded service offering provides platforms for immune monitoring and biomarker screening with high-throughput flow cytometry and ELISpot testing. Celerion has a pre-qualified interferon gamma ELISpot assay, allowing for a significantly faster validation process with study-specific antigens, thereby accelerating the development process for cell and gene therapies and vaccines alike.
Celerion also supports vaccine development programs by offering fully automated ELISA assays in a Biosafety Level 2 environment.
Flow cytometry is used to support the drug development of cell, gene, and immunotherapies with endpoints including immune-phenotyping of immune cells and receptor occupancy assessment. Celerion also provides high-throughput molecular biology testing for vector shedding analysis for gene therapies in compliance with current regulations as well as biodistribution to support GLP studies and transgene expression analysis using RT-PCR.
“Our state-of-the-art cellular and molecular division has been built with the increased demand for new modalities in mind,” said Ray Farmen Ph.D., Vice President of Global Bioanalytical Sciences. “Celerion’s co-located clinical research facilities and bioanalytical laboratories enable timely method validation of many assays. We have qualified assays, validated analytical platforms, and trained staff available to quickly start your project and deliver to demanding timelines.”
Farmen adds that Celerion has decades of regulatory experience, scientific excellence, and laboratory investments that enable accelerated development of these complex therapies.
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.
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