Identify and Quantify Individual Host Cell Proteins

Does Your HCP ELISA Measure Up?
Jul 12, 2018
By Sciex

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What is your HCP ELISA measuring? And is it good enough?

Regulatory requirements for biologics include that process-related impurities—host cell proteins— (HCPs) should be identified, characterized as appropriate, and quantified.

Enzyme-linked immunosorbent assay (ELISA) is the gold standard for HCP analysis but the method has some drawbacks. It provides only a single number (ng HCP/mg drug substance) and does not provide information about the specific HCPs. Also, the accuracy of the ELISA data depends highly on how the antibodies used in the assay are prepared and qualified.

In this webcast, A Data Independent Acquisition methodology (SWATH®) Acquisition is applied to give data that provides both reproducible identification and absolute quantification of each individual HCP as well as the total HCP content. This method Analysis is generic and can be applied across many Biotherapeutics for vaccines, mAbs, small therapeutic proteins, and protein biopharmaceuticals expressed in different cell lines and expression systems. The sample analysis workflow is fast, sensitive, and is applicable for different sample types, including antigens used for immunization and ELISA calibration, down-stream process samples, as well as purified drug substances.

Key Learning Objectives:

  • Learn How SWATH® Acquisition is enabling identification and quantification of individual host cell proteins
  • How to evaluate ELISA assays for analysis of host cell protein with SWATH® Acquisition
  • Hear how to optimize your bioprocess for removal of process impurities



Thomas Kofoed, Ph.D., Co-founder and CEO, Alphalyse


Date and Time:

Live: Thursday, 12 July, 2018 at 11 am EDT | 8 am PDT | 1600 BST | 1700 CEST

After the final airing of the webcast on 12 July, 2018 it will be available on demand until 12 July, 2019. 

Sponsor: SCIEX

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