Biologics Analysis Workflow™

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Biologics Analysis Workflow system photo

The Biologics Analysis Workflow is a suite of products designed and validated to assess the purity or identity of biological products in a cGMP regulatory environment. The Biologics Analysis Workflow provides:

  • Increased throughput
  • Simplified, sensitive gel staining
  • Accurate and reproducible imaging
  • Easy data analysis

The Biologics Analysis Workflow includes a set of integrated protein electrophoresis solutions for each step of the workflow:

Step 1: Separate samples

Criterion™ TGX™ precast gels — increased throughput with fast run times and more sample loading wells

The unique properties of TGX chemistry reduce run times to as little as 20 minutes. These gels have a 1-year shelf life and utilize the standard Laemmli buffer system. The midi-sized Criterion format allows you to load up to 26 samples while maintaining the required resolution. Additionally, the characteristic upper buffer chamber reduces the amount of running buffer required.

Step 2: Stain proteins

QC Colloidal Coomassie stain — highly sensitive, reliable, end-point stain designed for quantitative analysis of proteins

QC Colloidal Coomassie stain enables the detection of nanogram levels of protein. The colloidal chemistry improves the protein-to-dye binding ratio, reducing background staining and improving sensitivity. QC Colloidal Coomassie stain is an end-point stain that was designed and optimized for quantitative analysis with the GS-900™ densitometer. The stain is ready to use without mixing or the addition of other reagents. The stain is formulated with ethanol instead of methanol, eliminating the need for hazardous waste disposal.

Step 3: Visualize proteins

GS-900™ calibrated densitometer — reproducible imaging of protein gels, blots, and film across a wide dynamic range

To ensure the accuracy of each scan, the GS-900 calibrated densitometer contains internal optical density tablets that are scanned and used for calibration before each run. The calibration of the GS-900 densitometer can be validated with the GS-900 calibrated densitometer installation and qualification kit, which utilizes an external target to confirm accuracy of the internal target, ensuring the accuracy and reproducibility of the GS-900 densitometer. With red/green/blue tricolor CCD technology, the GS-900 calibrated densitometer enables the imaging and quantitation of film, blots, and gels stained with a wide variety of stains. The wide dynamic range permits the quantitation of proteins from 0–3.4 OD.

Step 4: Analyze results

Image Lab™ image analysis software — effortless analysis of samples with an intuitive, user-friendly interface

Gel analysis is greatly simplified with Image Lab software. The ability to automate analyses saves time and ensures consistent analysis from run to run. Image Lab software includes detailed tutorials and requires no previous imaging experience to produce optimum gel and blot images. The flexible system allows users to easily modify analysis settings to match SOPs and fine-tune band detection, background level, and other settings. Image Lab software makes reporting easy with the ability to create customized reports and meets regulatory requirements with an optional 21 CFR Part 11 module.

Calibration frequency Automatic calibration before every scan
21 CRF Part 11 Yes (optional software package)
Acquisition software ImageLab™ software ≥ 5.0
Light source LED
Wavelength 400–750 nm
Absorbance range 0.0 to 3.4 OD Transmissive
0.0 to 2.7 OD RD reflective
Transmissive scan area 29 × 33 cm
Reflective scan area 29 × 33 cm
Bit depth 16-bit grayscale
Minimum pixel size 36.3 µm (700 dpi)
Image Lab™ software OS compatibility Windows XP, 7
Connection type USB 2.0
Imager dimensions (W x L x H) 62.7 × 37.6 × 18.5 cm
Imager weight 16.1 kg
Applications Densitometry
Calibrated colorimetric gel and blot quantitation
Biologics Analysis Workflow photo
Biologics Analysis Workflow

170-7991W
Biologics Analysis Workflow product suite, includes gel densitometry system, scanner, cables, PC-compatible Image Lab™ Software, optional 21 CFR Part 11 and Instrument Qualification/Operations Qualification module

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GS-900™ Calibrated Densitometer Regulatory Tools Package
GS-900™ Calibrated Densitometer Regulatory Tools Package

170-7993
Pkg of 1, set of protocols for validating the calibration of GS-900™ calibrated densitometer (#170-7991), Image Lab™ Security Edition with 21 CFR Part 11 Module

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GS-900™ Installation Qualification/Operations Qualification (IQ/OQ) Kit
GS-900™ Installation Qualification/Operations Qualification (IQ/OQ) Kit

170-7994
Pkg of 1, set of protocols for validating the calibration of GS-900™ calibrated densitometer (#170-7991)

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Image Lab™ Software

170-9690
Software, PC or Mac, for automated image capture, optimization, and 1-D data analysis, for use with Gel Doc™ EZ, Gel Doc XR+, ChemiDoc™ XRS+, ChemiDoc MP, and GS-900™ imaging systems

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Image Lab™ Software, Security Edition, 1 license
Image Lab™ Software, Security Edition, 1 license

170-9691
21 CFR Part 11 module for Image Lab software, 1 license, use with GS-900™, Gel Doc™ EZ, Gel Doc XR+, ChemiDoc™ XRS+, and ChemiDoc MP imaging systems

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Image Lab™ Software, Security Edition, 5 licenses
Image Lab™ Software, Security Edition, 5 licenses

170-9692
21 CFR Part 11 module for Image Lab software, 5 licenses, use with GS-900™, Gel Doc™ EZ, Gel Doc XR+, ChemiDoc™ XRS+, and ChemiDoc MP imaging systems

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Image Lab™ Software, Security Edition, 10 licenses
Image Lab™ Software, Security Edition, 10 licenses

170-9693
21 CFR Part 11 module for Image Lab software, 10 licenses, use with GS-900™, Gel Doc™ EZ, Gel Doc XR+, ChemiDoc™ XRS+, and ChemiDoc MP imaging systems

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Number Description Options
6385 Biologics Analysis Workflow™ Brochure, Rev A Click to download
10031959 Instruction Manual, Image Lab Software for the GS-900 Calibrated Densitometer, Rev B Click to download
10033507 Biologics Analysis Workflow Product Information Sheet Click to download
6387 Biologics Analysis Workflow™ Model Comparability Study — Obtaining cGMP Approval for Validated SDS-PAGE Assays with the GS-900™ Calibrated Densitometer, Rev B Click to download
6040 Electrophoresis Guide, Interactive PDF, Rev B Click to download
6007 Criterion TGX Precast Gels Product Information Sheet, Rev B Click to download [ Add to Cart (Free) ]
4006028 Instruction Manual, Laemmli Sample Buffer, Rev J Click to download
10032602 QC Colloidal Coomassie Stain Manual, Rev A Click to download
6421 Image Lab™ Software for the GS-900™ Densitometer Quick Start Guide, Rev A Click to download
10030885 Installing your GS-900™ Calibrated Densitometer Quick Start Guide, Rev C Click to download