AccuSignal™ E. coli HCP ELISA Kit
AccuSignal™ E. coli HCP ELISA Kit
Rockland’s AccuSignal™ E. coli HCP ELISA Kit is a robust sandwich enzyme-linked immunosorbent assay (ELISA) designed to detect contaminating E. coli HCPs in therapeutic products throughout their purification processes, including early, mid, late, and final stages. Additionally, it can detect HCPs from both B and K-12 E. coli strains, which are commonly employed in the biomanufacturing of drug substances.
Introducing AccuSignal™ E. coli HCP ELISA Kit
Escherichia coli (E. coli) is a widely utilized organism in scientific research and biomanufacturing of therapeutic biologic drug substances. Monitoring the concentrations of impurities, particularly E. coli Host Cell Proteins (HCP), is of paramount importance in biomanufacturing processes. The primary objective of purification processes is to eliminate HCPs to minimize immunogenicity, enhance potency, and ensure the stability of a pure drug substance.
E. coli HCPs from a sample are captured on the AccuSignal™ E. coli HCP ELISA Kit plate, which contains pre-immobilized anti-E. coli HCP antibodies. The kit detection antibodies (anti-E. coli HCP antibodies) are conjugated with Horse Radish Peroxidase (HRP). Upon exposure to 3,3’,5,5’-Tetramethylbenzidine (TMB) substrate, HRP activates, resulting in a color change that can be measured with a plate reader at 450 nm. This optical density (OD) value is directly proportional to the concentration of E. coli HCPs, which can be calculated by interpolating against a Four-Parameter Logistic (4PL) standard calibration curve.
Fig. Standard curve (4PL) of the Accusignal E. coli HCP ELISA Kit.Key Benefits:
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Sensitive antibody enables reliable detection of E. coli HCP
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Strong E. coli HCP coverage minimizes the risk of undetected HCP
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Wide dynamic range provides confidence in results across a large range of potential concentrations throughout the entire purification process
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Consistently low inter- and intra-plate variation ensures reproducible data
General Kit Specifications:
| Specification | Parameter |
| Limit of Detection (LOD) | ≤ 1.0 ng/mL |
| Lower Limit of Quantification (LLOQ) | 3.0 ng/mL |
| Range | 2.6 – 250.0 ng/mL |
| Precision (Intra-Assay Variability) | ≤ 20% |
| Precision (Inter-Assay Variability) | ≤ 25% |
| Recovery of Each Standard | 80-120% |
Why Rockland?
60+ Years of Experience
Rockland has been a trusted provider of critical reagents and services for over 60 years, with expansive knowledge and experience in all phases of product development
Secure Supply Chain
Every aspect of manufacturing is completed with fully traceable manufacturing processes and quality assurance systems
US-based Manufacturing
Our in-house R&D and manufacturing capabilities allow for reproducibility and minimal lot-to-lot variability
AccuSignal™ E. coli HCP ELISA Kit Components
The kit contains a comprehensive set of components, ensuring efficient HCP quantification.
| Component | Size |
| E. coli HCP Antibody-coated 96-well Strip Plate | 1 plate |
| E. coli HCP Detection Antibody | 140 μL |
| E. coli HCP Protein Standard | 1 μg |
| Sample Buffer | 50 mL |
| Stop Buffer | 20 mL |
| TMB Buffer | 20 mL |
| Wash Buffer (10X) | 60 mL |
| Plate Sealer | 1 sheet |
