Application Note

Bridging Anti-E. coli HCP Antibodies and E. coli Antigens from Two Cygnus E. coli HCP ELISA Kits by AAE-MS™

By Jared Isaac, Bryan Lanning, Jacob Stubbs, Alla Zilberman, and Eric Bishop

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In the biopharmaceutical industry, it is important to monitor host cell proteins (HCPs) to show clearance during drug substance (DS) purification. ELISA is qualified for dilutional linearity, accuracy, precision, and lower limit of quantitation (LLOQ) which allows you to do this.

Once an HCP ELISA method has been qualified and validated, the company must ensure that critical reagents supporting that validated assay will last throughout the lifetime of the program. However, polyclonal HCP antibodies for ELISAs cannot be supplied indefinitely, and sometimes such critical reagents must be resupplied. Explore the necessary steps to support a transition from the E. coli HCP ELISA Kit to the E. coli HCP ELISA Kit, 2G. Experts quantify and compare the characteristics of the original and new HCP antigen lots of E. coli HCPs, as well as performing a comparative coverage analysis study to assess the reactivity of anti-E. coli HCP antibodies that support these kits.

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