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Threshold Immunoassay 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.

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 radioimmunassays 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. The Threshold System's proven advantages of sensitivity, speed, reproducibility and reliability, as well as MDC's strong technical experience and support, have elevated this system to be the gold standard in the industry.

  • 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

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, peptides and total DNA at low concentrations using an enzyme-linked immunoassay. Analytes are measured by incubating them with the appropriate antibody, binding protein or oligonucleotide probe which is labeled with streptavidin and conjugated to urease to form a complex. The sample mixture is then filtered through a biotinyylated membrane to actively capture and concentrate the analyte complex from the sample matrix. The filter is inserted into the reader and detection of the enzyme-labeled complex occurs in 90 sec by measuring the rate of enzyme turnover using a low noise silicon sensor.

Assay sensitivity for proteins is typically equal to or better than radioimmunassays and at least 10X better than ELISAs. For total DNA, assay sensitivity of 2 pg can be achieved. The Threshold Software controls the instrument and collects and analyzes the data. To simplify assay development, the following reagent kits are available to label your antibodies or commercially available antibodies,

  • 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.

Threshold Software controls the workstation and collects and analyzes data. It includes five standard curve fits to provide the highest accuracy when quantitating unknowns. A complete summary report detailing the results can be printed or exported for further analysis.

The optional Threshold Enterprise Software has a spike recovery report for analysis of the results within the software application, a complete validation package that allows current and future Threshold System users to comply with GLP/GMP/FDA 21 CFR Part 11 requirements. Threshold Enterprise Software includes the following security tools:

  • Individual passwords and user IDs
  • Permission managed access to major features
  • Audit trail of log-on and log-off activities and all user actions that modify the file
  • Signed electronic statements

Related Collateral

Data Sheet

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 (R8010/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