Creation of a broadly reactive E. coli HCP detection ELISA suitable for K Strain and B Strain Platforms

Escherichia coli (E. coli), is a major host expression platform for production of biopharmaceuticals. It has utility for large-scale production of proteins due to its high yield, rapid growth that is amenable to scale and low cost. While limited to proteins that don’t require complex post-translational modifications, it is the model of choice for proteins such as cytokines and hormones, including insulin, which was first purified from E. coli by Eli Lily in 1978. During purification of biological drugs from the host system, the presence of host cell protein (HCP) contaminants must be assayed, both to demonstrate effective HCP clearance and manufacturing consistency.

Rockland has developed an ELISA to facilitate the monitoring of E. coli HCP contaminants during the bioprocessing workflow. The assay has a run time of < 2 hours with a standard curve range of 1 – 250 ng/mL and an LLOQ of ≤ 3 ng/mL. The assay is compatible with both B and K E. coli strains and in a range of buffer matrices.

In this poster we show how Rockland develops an HCP assay, ensuring robust performance and reproducibility in our critical reagents to effectively measure E. coli HCPs in bioprocess samples.