Immunogenicity Testing Services

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  • Published date: June 26, 2019
  • Modified date: October 16, 2019
    • Shirley, New York, United States

Immunogenicity testing is a crucial part of biopharmaceutical development. More stringent regulations regarding immunogenicity assay performance necessitates the development of assays exhibiting excellent sensitivity, precision, free drug tolerance and minimal matrix effects. Immunogenicity assays can be applied in detection and confirmation of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) supporting nonclinical and clinical studies.

The development and validation of immunogenicity assays is under constant discussion within the industry. Based on our GLP-compliant service laboratories, Profacgen is involved in international workshops and has R&D programs to keep ahead of the latest developments in this area, so that we can best help our customers to accelerate their drug discovery and development programs.

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