HCP Detection with unmatched Coverage

BioQuantiPro™ CHO HCP ELISA Kit - Sensitive Detection of Host Cell Protein Impurities


Analysis and removal of HCP is one of the biggest challenges in developmental processes of recombinant produced biologicals drugs. Rockland's BioQuantiPro™ CHO-HCP ELISA Kit is specifically designed for standard to high throughput applications in order to faciliate the automation process. Key feature of this kit is the unmatched CHO-HCP contaminant coverage.

Key Features

The CHO-HCP ELISA kit (ABIN6254804) meets industry standards for specificity and sensitivity and offers high reproducibility with low lot-to-lot variation. Together with the high precision and the awesome sensitivity it is perfectly suited for detection of host cell protein impurities in Chinese hamster ovary (CHO) cells.

  • Broadest CHO-HCP contaminant coverage on the market available
  • Sensitivity 2 ng/mL
  • Low variability
  • Low lot-to-lot variation
  • High reproducibility
  • Rapid time to result
  • Easy to use

Intended Use

Validity of the kit tested in various buffer matrices used for protein purification. In quality control applications, subject to thorough validation and qualification by each laboratory, these kits may also be useful for lot release testing. This CHO-HCP ELISA kit is able to provide relevant and specific data guiding process improvement and decreasing the level of HCP contamination.

The Kit is a sandwich ELISA designed to detect CHO-HCP contamination in process-derived samples. It uses purified antibodies generated against CHO-K1 cell lysates that were derived from cells grown in chemically-defined media. These antibodies react strongly with CHO-K1 cell lysates, showing the highest sensitivity for cells harvested at 60-85 % viability. Detection and quantification levels of samples derived from cell culture fluid (CCF) will vary and are sometimes limited. If a sample matrix is used in the assay, it is recommended to validate accurate recovery by first diluting the standard provided in the kit into the sample matrix.

Product Details

The polyclonal antibody covers host cell contaminants, with especially good coverage in the extremes, including both low abundancy and high abundancy proteins, as well as poorly immunogenic and highly immunogenic proteins.

  • Precision: Intra Variability <10% / Inter Variability <15%
  • Sensitivity: LLD=2 ng/mL / LLQ=4 ng/mL
  • Coverage: 89% Total across low molecular weight and high molecular weight
  • Accuracy: within 15% (LLQ: within 20%)
  • Linearity: R2=0.99 for assay range 2-200ng/mL
  • Matrix Effect: Most buffer systems yielded 90-120% recovery

Quadrant Analysis for Antibody Coverage. This CHO-HCP ELISA kit shows a 89 % total coverage across LMW and HMW, which is broadest CHO-HCP contaminant coverage available on the market.

Quadrant Analysis for Antibody Coverage

Quadrant Analysis for Antibody Coverage

The antibodies developed for this kit were validated for broad coverage of CHO-HCP samples using two-dimensional (2D) Western blots. The reagents demonstrated broad coverage and identified difficult-to-detect low molecular weight (LMW) proteins in Q3 and Q4, in addition to high molecular weight (HMW) proteins in Q1 and Q2. This data indicates a robust reagent suitable for use in an HCP ELISA kit.

Quadrant 1 (Q1): HMW proteins (above 50 kDa) in low pH region (below pH 6.5)

Quadrant 2 (Q2): HMW proteins in high pH region (above pH 6.5)

Quadrant 3 (Q3): LMW proteins (below 50 kDa) in low pH region

Quadrant 4 (Q4): LMW proteins in high pH region

Coverage Comparison with Competitor Products

CHO-HCP proteins were detected by anti-CHO-HCP antibody, used in ABIN6254804, and a competitor's generic anti-CHO-HCP antibody via 2D Western Blot using HRP detection. Visualization by a high sensitivity in-gel protein stain.

Coverage Comparison: on the left the CHO-HCP polyclonal antibody in ABIN6254804; on the right the competitor's CHO-HCP antibody.

Coverage Comparison: on the left the CHO-HCP polyclonal antibody in ABIN6254804; on the right the competitor's CHO-HCP antibody. Blue = Detection by antibody only. Green = Detection by stain + antibody. Red = Detection by stain only.

Coverage Analysis

Coverage CHO-HCP antibody in ABIN6254804 Competitor's CHO-HCP antibody
Total Coverage 89% 78%
Q1 99% 96%
Q2 91% 92%
Q3 92% 67%
Q4 76% 59%

Kit Components

The following reagents and materials are provided in the BioQuantiPro™ CHO-HCP ELISA Kit

  • CHO-HCP Detection Antibody
  • CHO-HCP Antibody-coated 96-Well Strip Plate
  • CHO-HCP Protein Standard
  • HCP Kit Sample Buffer
  • HCP Kit Wash Buffer (10X)
  • HCP Kit TMB Buffer
  • HCP Kit Stop Buffer
  • Plate Sealer

For more information about the BioQuantiPro CHO-HCP ELISA kit please do not hesitate to contact our scientific customer support, via email, or live chat, or give us a call!