Threshold® Contaminant Detection System
Dedicated platform for the rapid quantitation of biopharmaceutical products or contaminates from bioreactor/fermenters, downstream processing or final product quality control
The production of biopharmaceuticals, such as monoclonal antibodies, recombinant proteins, vaccines, and nucleic acids requires special techniques and quality control methods. Electrophoresis, chromatography, and immunochemical methods are commonly used together to monitor and optimize the biopharmaceutical manufacturing process. Threshold® is a dedicated platform for the rapid quantitation of biopharmaceutical products or contaminants from bioreactors/fermenters, downstream processing and final product quality control. The system is ideal for the quantitation of proteins, peptides and non-sequence specific total DNA.
Description
Features
- Pre-configured kits to analyze peptides, proteins and total DNA using a single system
- All reagents provided to label your antibodies or commercially available antibodies quickly and easily
- Assay dynamic range of 2 logs or greater enables the use of the same method from purification to product QC
- High assay sensitivity without the use of radioactive reagents that require expensive disposal
- Assay precision typically <10% for reproducible quantitation of contaminant levels in final product
- Hybridization of the analyte occurs in the liquid phase for faster binding kinetics
- Antigen-antibody complex is captured and concentrated on a membrane to achieve sensitivity equal to or better than radioimmunoassay, and at least 10 times better than ELISAs
- Rapid sample analysis streamlines media selection and optimization of purification conditions
- Strepavidin’s strong affinity for biotin captures and concentrates analyte for high assay selectivity
- The speed and sensitivity of Threshold enables the monitoring of protein production during the early stages of fermentation
- Immunoassay detects protein degradation and conformational changes of protein products
- Accurate quantitation to identify the optimal harvest time to maximize product yield from fermentations
- Validated assays using quality controlled reagents and software
- Software requires individual passwords and user IDs to access, managed access to major features, audit trail, and signed electronic statements complies with FDA 21 CFR Part 11 requirements
