Dedicated platform for the rapid quantitation of biopharmaceutical products or contaminates from bioreactor/fermenters, downstream processing or final product quality control(生物制品污染物残留检测）如疫苗中DNA残留量检测

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. The Threshold®  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 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.

 

General Specifications

Threshold System

Dimensions (in.)	14.3 (W) x 22.5 (L) x 6.5 (H)
Dimensions (cm)	36.3 (W) x 57.2 (L) x 16.5 (H)
Power	110 VAC at 60 Hz or 220 VAC at 50 Hz; 4 outlets

 Threshold Auxillary Manifold 

Dimensions (in.)	8.0 (W) x 15 (L) x 4.3 (H)
Dimensions (cm)	20.3 (W) x 38.1 (L) x 10.8 (H)

Computer Specifications

Intel Core 2 Duo E8400 6M Cache, 3.0 GHz, 1333 MHz FSB

Windows XP Pro O.S.

CD-ROM drive

2 GB RAM

160 GB SATA Hard Disk

 

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:

The Threshold 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 Threshold 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 learn more: link to new HTML page referenced on the last page of this document). To simplify assay development, the following reagent kits are available to label your antibodies or commercially available antibodies,

Threshold's 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.

The Threshold 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, Thresholds Total DNA assay measures DNA with broad sequence specificity.

Part Number	Description
0200-0500	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 kits
0200-0506	Threshold System includes: instrument workstation, THS Software for Windows, reader/electrode Kits (2), 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.
0200-0501	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 kits
Accessories
0200-0504	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
9000-0087	8-Channel Pipettor in Threshold sample (8 tubes) array
9000-0088	Pipette Tips  (1 ml, for 8-Channel Pipettor 9000-0087) 1000/case
6706-0002	Reference Electrode Kit includes:   (1) reference electrode,  (1) electrolyte solution,   (1) replaceable barrel,  (1) filling tube   Instructions
9000-0089	Threshold test tube rack in Threshold sample (8 tubes) array
Software
0200-6014	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)
0200-6145	THRESHOLD ENTERPRISE V1.0.2  LICENSE.
0200-6146	THRESHOLD ENTERPRISE V1.0.1 VAL PKG. (Replaced part nubmer 0200-6064)
0200-0509	Threshold Software for Windows 95/NT Upgrade Package (from  1.04) includes:   operator manual for Windows and diskette
0200-0508	Threshold Software for Windows upgrade package includes:   operator manual for Windows and diskette
Reagents and Consumables
R9010	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
R9004 DNA BULK KIT	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)
R9009 DNA 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)
R9003	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
R9002	Immuno-Ligand Assay Labeling Kit  includes:   2 vials Biotin label (5 mg/vial),  2 vials Fluorescein label (5 mg/vial)
R9016	Threshold DNA kit without filter
R9015	Threshold DNA Bulk Kit without filter
R8003	Threshold Sticks, Biotinylated   Box of 20, 160 determinations
R8004	Threshold DNA Zero Calibrator includes:   (10) Zero Calibrator Vials 10 ml
R8009	Threshold Sticks: blank (Box of 20)
R8007	Threshold Filter Unit Kit includes:   8 filter blocks  8 filter bases
R8030	Threshold Sticks: Biotinylated 5 Microns  (Box of 50)