Ideal for the quantitation of proteins, peptides and non-sequence specific total DNA.

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.

 

The Threshold Immunoassay System measures a wide range of analytes such as host cell proteins, bovine contaminants (BSA, IgG, transferring and insulin), Protein A and G, and total DNA at low concentrations. To simplify assay development, all reagents are supplied in pre-packaged kits to label your antibodies or commercially available antibodies. To optimize the interaction between the antigen and antibody, binding occurs freely in solution where the molecules are maintained in their native conformation and antibodies retain 100% of their activity. Assay sensitivity for proteins and peptides is typically equal to or better than radio immunassays and at least 10X better than ELISA assays. When measuring DNA, sensitivity as low as 2 pg can be achieved. Typically assays have a dynamic range of 2 logs or greater, so fewer sample dilutions are required for accurate quantitation. Assays are fast and are complete in as little as 90 seconds.

 

Optional Threshold Enterprise Software is available with a complete validation package and security tools that comply with GLP/GMP/FDA 21 CFR Part 11 requirements.

Applications of Threshold Immunoassay System

  • Threshold Immunoassay Total DNA Assay Kit

    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.

  • Threshold Immunoligand Assay Kit

    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.

Resources of Threshold Immunoassay System

Threshold Immunoassay System

Description
Part Number
Threshold Total System (110V) includes: instrument workstation, THS software for Windows 95/NT (compatible with Windows XP/2000), Pentium -based computer, color monitor, operator manual, one-year-limited warranty covering parts and labor, training for DNA or ILA application at MDC lab (2), cleanable reader/electrode kit
0200-0500
Threshold System includes: instrument workstation, THS Software for Windows, reader/electrode kit, manual, one-year warranty, training for (1) product, one starter kit is included and the customer must specify either R9010 or R9008 on the PO.
0200-0506
Threshold Total System (220V) includes: Iinstrument workstation, THS software for Windows 95/NT (compatible with Windows XP/2000), Pentium -based computer, color monitor, operator manual, 1 year limited warranty covering parts and labor, Training for DNA or ILA application at MDC lab (2), cleanable reader/electrode kit
0200-0501
Accessories
Threshold Auxiliary Manifold System (4 additional filtration channels) includes: auxiliary manifold, interconnect tubing, interconnect cable, waste tubing, 1 year limited warranty covering parts and labor
0200-0504
Pipette Tips (1 ml, for 8-Channel Pipettor 9000-0087) 1000/case
9000-0088
Reference Electrode Kit includes: (1) reference electrode, (1) electrolyte solution, (1) replaceable barrel, (1) filling tube Instructions
6706-0002
Threshold test tube rack in Threshold sample (8 tubes) array
9000-0089
Threshold Contaminant Detection System IQ/OQ Validation Protocols (Detailed hardware specifications with complete IQ/OQ checklists for use in system owner's qualification plans)
0112-0172
Software
Enterprise Administrator v1.1 includes: Windows-only CD ROM and Software User Manual - 1 copy supports 25 users of SoftMax Pro or Threshold Enterprise Software Enterprise (software not included)
0200-6014
Threshold Enterprise v1.0.2 License
0200-6145
Threshold Enterprise v1.0.1 Val Pkg (replaced part nubmer 0200-6064)
0200-6146
Threshold Software for Windows 95/NT Upgrade Package (from 1.04) includes: operator manual for Windows and diskette
0200-0509
Threshold Software for Windows upgrade package includes: operator manual for Windows and diskette
0200-0508
Reagents and Consumables
DNA Starter Kit includes: (1) Total DNA Assay Kit, (100) Sarstedt 2 ml test tubes, (100) biopure pipette tips 1 ml, (100) biopure pipette tips 200
R9010
DNA Bulk Kit (R8010/R8007) 800 determinations includes: (104) Threshold Sticks, (20) Threshold Blank Sticks, (66) Zero Calibrator, (20) Positive Control, (20) High Calibrator, (100) DNA Labeling Reagens (13) Reconstitution Buffer, (10) Substrate Concentrate, (19) Wash Solutions, (13) Filter Unit Kits (104 units)
R9004 DNA
BULK KIT
Total DNA Assay Kit (R8022/R8007) 64 determinations includes: (10) Threshold Sticks, (6) Zero Calibrator, (2) Positive Control, (2) High Calibrator, (8) DNA Labeling Reagens, (1) Reconstitution Buffer, (1) Substrate Concentrate, (2) Wash Solutions, (1) Filter Unit Kits (8 units)
R9009 DNA
KIT
Immuno-Ligand Assay Detection Kit 192 determinations includes: (1) Universal Standard Reagent, (6) Enzyme Reagent, (1) Capture Reagent, (6) Threshold Blank Sticks, (24) Threshold Sticks, (1) Substrate, (1) Assay Buffer Concentrate, (1) Wash Buffer Concentrate
R9003
Immuno-Ligand Assay Labeling Kit includes: 2 vials Biotin label (5 mg/vial), 2 vials Fluorescein label (5 mg/vial)
R9002
Threshold DNA kit without filter
R9016
Threshold DNA Bulk Kit without filter
R9015
Threshold Sticks, Biotinylated Box of 20, 160 determinations
R8003
Threshold DNA Zero Calibrator includes: (10) Zero Calibrator Vials 10 ml
R8004
Threshold Sticks: blank (Box of 20)
R8009
Threshold Filter Unit Kit includes: 8 filter blocks 8 filter bases
R8007

Featured Applications

Ready to get started?

We are ready to help you solve your tough research challenges. Our proven solutions and highly qualified teams across the globe can help advance your next big discovery.

Ready to get started?

We are ready to help you solve your tough research challenges. Our proven solutions and highly qualified teams across the globe can help advance your next big discovery.