Journal of Bioprocessing & Biotechniques

Alexandre Ambrogelly

Publications

• Research Article
  The Comparison of Chemiluminescent- and Colorimetric-detection Based ELISA for Chinese Hamster Ovary Host Cell Proteins Quantification in Biotherapeutics
  Author(s): Fengqiang Wang, Dennis Driscoll, Daisy Richardson and Alexandre AmbrogellyFengqiang Wang, Dennis Driscoll, Daisy Richardson and Alexandre Ambrogelly
  
  Biologics manufacturing requires the clearance of Host Cell Proteins (HCPs) from recombinant therapeutic protein to acceptable low levels to ensure product purity and patient safety. To ensure adequate removal, a highly sensitive method, commonly in the form of Enzyme-Linked Immunosorbent Assay (ELISA), is necessary to quantify the HCPs amount in process intermediates and drug substance. We report the development of a chemiluminescent detection based ELISA (luminescent ELISA) in lieu of previously used colorimetric method (colorimetric ELISA) to improve assay sensitivity for the quantification of Chinese Hamster Ovary (CHO) HCPs in a monoclonal antibody product (mAb-A). For luminescent ELISA, Pierce Supersignal ELISA Femto was chosen as the substrate to replace colorimetric substrate TMB. The assay performance of luminescent and colorimetric ELISA was directly compared side-by-side. O.. Read More»
  DOI: 10.4172/2155-9821.1000136

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