Rockland Launches AccuSignal™ E. coli ELISA Kit for Precise Detection of HCPs in Biologic Manufacturing

FEBRUARY 3, 2025

LIMERICK, Pa .— For over 60 years, Rockland has been at the forefront of providing innovative tools for the biopharmaceutical industry, offering antibodies, assays, and supporting reagents. Our expertise in antibody and immunoassay development ensures that we deliver accurate impurity detection reagents to support every stage of biomanufacturing—from early to late-stage processing.

E. coli is the second most widely used biological drug expression platform, utilized for producing recombinant proteins and gene therapy vectors, making it essential to monitor and control HCP contamination during drug purification. The presence of these impurities can affect product stability, immunogenicity, and overall therapeutic efficacy, which is why effective detection and quantification are vital for ensuring the quality and safety of biologics.

The AccuSignal™ E. coli HCP ELISA Kit is designed to sensitively and accurately quantify E. coli HCPs in therapeutic products, particularly during downstream bioprocessing. With its broad dynamic range of 2.6–250 ng/mL and a low limit of quantification (LOQ) of 3 ng/mL, this kit delivers rapid results with a minimal assay run time of less than two hours—helping to streamline workflows in biologics manufacturing. The kit’s unique combination of sensitivity, speed, and compatibility with both B and K-12 E. coli strains makes it an invaluable tool for biomanufacturers.

“Delivering this E. coli HCP detection kit highlights Rockland’s ongoing commitment to providing high-quality products that advance the field of biologic manufacturing,” says Rob Hooper, Associate Director of Research. “Our growing portfolio of impurity detection tools for bioprocessing, combined with Rockland’s dedication to quality and reliable supply, positions us as a trusted partner for biopharmaceutical companies worldwide.”

The AccuSignal™ E. coli HCP ELISA Kit uses a sandwich ELISA format with a Rockland-generated, anti-E. coli HCP antibody, which is pre-immobilized to the plate to capture HCPs, while the detection antibody is directly conjugated to Horse Radish Peroxidase (HRP) for sensitive, specific, and reproducible results.

Learn more about the AccuSignal™ E. coli HCP ELISA Kit

About Rockland Immunochemicals, Inc.

Established in 1962, Rockland is a global biotechnology company developing leading-edge analytical tools for biologics, and cell, gene, and RNA therapy development. We specialize in fully customized, fit-for-purpose, host cell protein antibodies and assays. With USA-based R&D, manufacturing, and raw material facilities, Rockland can fully develop, optimize, and validate each analytical tool, ensuring fully traceable processes for a secure long-term supply. Learn more about Rockland at www.rockland.com.