Impurity Detection ELISA Kits
Impurity Detection ELISA Kits
Mitigate the risk of impurities in therapeutic development with ELISA kits to ensure product safety and efficacy. Rockland has developed and extensively validated products to provide industry professionals with complete solutions for impurity detection. From host cell protein (HCP) quantification to ligand leakage detection, these assays provide scalable, sensitive, and selective solutions for various stages of product development.
HCPQuant CHO HCP ELISA Kits
In collaboration with Cytiva Life Sciences (formally, GE Healthcare Life Sciences), Rockland has developed ELISA kits for the detection of host cell protein impurities.
The Amersham HCPQuant CHO HCP ELISA Kits exceed industry standards for specificity and sensitivity. These host cell protein ELISA kits are specifically designed for standard-to-high throughput HCP analysis and can be easily adapted for automation. The included antibodies have been specifically designed to detect HCP impurities and to measure analytes from crude cellular harvests, cell culture lysates, and process intermediates.
Purified antibodies were generated against a CHO-K1, grown in chemically defined media. These antibodies react strongly with CHO-K1, showing the highest sensitivity for cells harvested at 60–85% viability. Detection and host cell protein quantification of high-viability cell culture fluid (CCF)-derived samples will vary.
Key features include:
✓
Maximum Sensitivity
For strong host cell protein coverage and minimized risk of undetected impurities.
✓
Wide Dynamic Range
For excellent dilution linearity and increased confidence during the entire purification process.
✓
Low Inter- & Intra-plate Variation
For consistent, reproducible host cell protein analysis.
Available HCP Products
| Product | Details |
| CHO HCP ELISA Kit (Supernatant) | Learn more |
| Anti-CHO HCP Detection Antibody (Supernatant) | Learn more |
PrismA ELISA Kits
The PrismA ELISA kit was specifically designed for use with Cytiva MabSelect PrismA™ resins with a focus on usability, robustness, and environmental sustainability. The kit includes the PrismA ligand, which is optimized for use in ELISA with polyclonal antibodies raised specifically against the PrismA ligand.
With the PrismA protein A ligand included in the kit, the need to separately source a standard and create a custom protocol is no longer necessary. Additionally, the kit boasts a high IgG tolerance to simplify sample preparation with sensitivity that minimizes the risk of undetected residual PrismA ligand.
Learn more on cytiva.com
AccuSignal™ Nuclease ELISA Kit
The presence of nuclease must be addressed in the manufacture of therapeutic products, as it can degrade nucleic acids, whether the drug’s genetic material or the patient’s own genetic material. To meet quality and safety standards, it is essential to ensure the absence of impurities, such as nuclease. To address these concerns, pharmaceutical manufacturers may implement purification and quality control processes that may include steps to remove or inhibit nucleases, ensuring the final product is safe, stable, and effective for patients.
This kit is a 96-well microtiter strip format sandwich ELISA that uses pre-immobilized anti-nuclease antibodies and biotinconjugated detection combined with streptavidin-HRP and TMB substrate to measure nuclease in a variety of therapeutic products and materials.
Learn more
Amersham Typhoon Biomolecular Imager
Using Rockland's primary and secondary antibodies and buffers in conjunction with the Amersham Typhoon imaging systems, you can expect simultaneous detection and quantification of specific proteins, which eliminates the need to strip and re-probe, while also reducing workflow time, increasing sensitivity, and allowing for precise quantitative analysis.
Amersham™ Typhoon™ Biomolecular Imager has pioneered a new generation of laser scanners, providing exceptional data quality through extremely sensitive detection, high image resolution, and broad linear dynamic range.
Features:
- Versatility — Extensive range of applications support gels, a tissue sections, multiwellplates, or even membranes for genomic and proteomic applications
- Accurate quantification — Gold standard for quantification due to the wide dynamic range with greater than fives order of magnitude
- High resolution image — Ability to visualize fine details in tissues sample with a 10 µm resolution
- Flexible — Modular design allows for customizable options to fit each users' needs.