Celerion Expands Cell-Based Assays Capabilities in Global Bioanalytical Services

November 12, 2014
Pharmaceutical Technology Editors

Celerion has expanded its laboratory capabilities in response to increasing demand for cell-based assays.

Celerion has expanded its laboratory capabilities in response to increasing demand for cell-based assays. Such assays are important in assessing drug activity or drug effect in clinical research.

Celerion has expanded this capability to meet clients’ demand for immunogenicity assessment for large molecule analysis and for immune monitoring assays in drug development. It also supports the recently issued FDA guidance on Immunogenicity Assessment for Therapeutic Protein Products.

Celerion’s laboratory in Zurich, Switzerland specializes in immunogenicity testing to detect anti-drug antibodies in serum samples of animals or patients treated with new drug therapies under development. The company leverages biological models for the assessment of antidrug neutralizing antibodies. This methodology can be used to examine cell morphology, cell differentiation, cell cycle effects including apoptosis, protein regulation, including modification and expression levels, and transcription activity. These assays are important biomarkers in clinical research programs of large molecule and biologically manufactured drugs, including biosimilars.    

Celerion’s laboratory in Lincoln, Nebraska is focused on flow cytometry for the detection and measurement of different cell populations within a biological sample.

This technique enables Celerion to develop de-novo flow cytometry assays such as cell signaling, target engagement, natural killer cell and immune function assessments. These methods are used to measure therapeutic response, stratification of patient populations and the evaluation of predictive diagnostic or prognostic biomarkers in clinical research. 

Source: Celerion

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