Rockland Launches Impurity Detection Kit for Accurate Measurement of Nuclease Across a Spectrum of Therapeutic Manufacturing Methods

2024-01-11

免疫疗法

The AccuSignal™ Nuclease ELISA Kit is designed to detect any Serratia marcescens endonuclease, such as Benzonase®, DENARASE®, and Turbonuclease, to evaluate manufacturing processes for biological therapeutics, gene therapy vectors, vaccine preparations, and more.

LIMERICK, Pa., Jan. 11, 2024 /PRNewswire/ -- For over 60 years, Rockland has been providing antibodies, assays, and supporting reagents to accurately reflect the quality of biopharmaceutical products from early- to late-stage bioprocessing. Rockland is a leading expert in antibody and immunoassay development, delivering high coverage and sensitivity against residual contaminants at any stage of development and manufacturing.

Assessing the presence of endonuclease derived from Serratia marcescens is a critical step in the manufacture of biopharmaceutical products, as it has the potential to degrade the nucleic acid structure of vaccines and therapeutics. To meet quality and safety standards, it is essential to ensure the absence of such impurities for safe, stable, and effective products. The AccuSignal™ Nuclease ELISA Kit is designed to sensitively and robustly quantitate a variety of residual endonuclease, including Benzonase®, DENARASE®, and Turbonuclease, found in samples from downstream bioprocessing when nuclease is used as a purification or process aid. The kit boasts a broad dynamic range of 0.03-20 ng/mL with excellent dilutional linearity and a minimal incubation time to expedite workflows and advance therapeutic innovations with confidence.

Terri Poole, Chief Commercial Officer, adds, "Delivering this nuclease kit is an example of Rockland's on-going commitment to provide high quality products that build on our growing portfolio of impurity detection tools for bioprocessing. Unwavering quality combined with our ability to consistently meet supply demands makes Rockland the clear choice for many biopharmaceutical companies."

The AccuSignal™ Nuclease ELISA Kit uses a sandwich ELISA format with a Rockland-generated, pre-immobilized anti-nuclease antibody and a biotin-conjugated detection antibody combined with streptavidin-HRP and 3,3',5,5'-tetramethylbenzidine (TMB) substrate for sensitive, specific, and reproducible results.

Learn more about the AccuSignal™ Nuclease ELISA Kit

About Rockland:

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.