powerlab

Molecular Devices

    Threshold System

                                          

     

     

    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®

    Immunoassay System 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 Threshold System

     

     

     

    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 the Threshold System 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

     

    Immunoligand Assay Kit

    Immuno-Ligand Assay (ILA) measures a broad range of analytes such as, drugs, proteins, and micro-organisms for biopharmaceutical

    development and production. Samples can range from fermentation supernatants, samples from a purification process and other

    biochemical preparations, to serum or other bodily fluids.

    Total DNA Assay Kit

    The Total DNA Assay quantitatively measures picograms of single-stranded DNA. Unlike hybridization techniques which require

    DNA probes or primers with a specific nucleic acid sequence, Total DNA assay measures DNA with broad sequence specificity.