Why is host cell protein (HCP) detection and removal so critical when manufacturing biologics? Product purity and, most importantly, patient safety depends on it. Sandwich ELISA has been a favored method for HCP testing due to its high sensitivity and high throughput, but challenges and limitations exist. Coverage depends strongly on the use of antibody reagents that adequately detect and capture HCPs.

In this webinar, we address effective techniques for both optimizing HCP ELISA coverage through the selection of reagents with good HCP coverage and applying appropriate tests for quantitating and validating that coverage. We also discuss other processes for HCP characterization and analysis beyond ELISA to deliver a comprehensive overall HCP analytical control strategy.

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