The Biologics Analysis Workflow consists of a suite of products that are designed and optimized to assess the purity or identity of protein biologics in a cGMP regulatory environment.

The Biologics Analysis Workflow provides:

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

Biologics Analysis Worflow steps

Fig. 1. The Biologics Analysis Workflow includes a set of integrated protein electrophoresis solutions for each step of the workflow.

Step 1: Separate Samples
Protein electrophoresis with Criterion™ TGX™ precast gels offers fast run times and higher throughput compared to mini gel formats.

Step 2: Stain Proteins
The QC colloidal Coomassie stain is designed for quantitative protein analysis, providing sensitivity, low background, and flexible stain times in addition to being a ready-to-use, environmentally friendly stain.

Step 3: Visualize Proteins
The GS-900™ calibrated densitometer auto-calibrates before each run for ultimate quantitative reproducibility. A wide 0–3.4 OD dynamic range enables quantitation of proteins, ensuring the detection of both highly abundant and dilute proteins.

Optimized products for the Biologics Analysis Worflow

Step 4: Analyze Results
Image Lab™ Software is protocol driven and allows for customization and easy recall of image acquisition and analysis settings. This design streamlines image acquisition and facilitates data analyses. Optional CFR module supports cGMP environments with FDA 21 CFR Part 11 compliance.

Each of these four elements has been optimized in the Biologics Analysis Workflow, ensuring reproducibility, accuracy, and reliability in purity assessments and quantitative analysis. For more details on the workflow and presentation of a model comparability study for obtaining cGMP approval for validated SDS-PAGE assays, refer to Bio-Rad Bulletin 6387 or visit the Biologics Analysis Workflow page.

Ordering Information

Catalog # Workflow Solution
1707991W Biologics Analysis Workflow (includes GS-900 densitometer, Image Lab™ software, and starter kit)
  Regulatory Packages
1707993 GS-900 Regulatory Tools Package (Image Lab software Security Edition, 21 CFR part II module, GS-900 IQ/OQ Kit)
1707994 GS-900 Calibrated Densitometer IQ/OQ Kit
1709691 Image Lab Software, Security Edition (21 CFR part 11), 1 license
1709692 Image Lab Software, Security Edition (21 CFR part 11), 5 licenses
1709693 Image Lab Software, Security Edition (21 CFR part 11), 10 licenses
  Protein Standards
1610363 Precision Plus™ Protein Unstained Standards, 10–250 kD, 1000 µl

Precision Plus Protein Unstained Standards, , 10–250 kD, 5 pack (5 x 1000 µl)

1610373 Precision Plus Protein All Blue Standards, 10–250 kD, 500 µl
1610393 Precision Plus Protein All Blue Standards , 10–250 kD, 5 pack (5 x 500 µl)
1610377 Precision Plus Protein Dual Xtra Standards, 2–250 kD, 500 µl
1610397 Precision Plus Protein Dual Xtra Standards, 2–250 kD, 5 pack (5 x 500 µl)
1610803 QC Colloidal Coomassie Stain, 1 L
1610732 10x Tris/Glycine/SDS, 1 L
1610747 4x Laemmli Sample Buffer, 10 ml
1610737 2x Laemmli Sample Buffer, 30 ml


Criterion™ TGX™ Precast Gels Ordering Chart


12+2-Well*, **
45 µl

30 µl

15 µl

Prep+2-Well*, **
800 µl

11 cm IPG Strip
Resolving Gel
567-1023 567-1024 567-1025
Resolving Gel
567-1033 567-1034 567-1035
Resolving Gel
567-1043 567-1044 567-1045
Resolving Gel
567-1073 567-1074 567-1075 567-1072 567-1071
Linear Gradient
567-1083 567-1084 567-1085 567-1082 567-1081
Linear Gradient
567-1093 567-1094 567-1095 567-1092 567-1091
Linear Gradient
567-1103 567-1104 567-1105 567-1102 567-1101
Linear Gradient
567-1113 567-1114 567-1115 567-1112 567-1111
Any kD™ 567-1123 567-1124 567-1125 567-1122 567-1121

* Multichannel pipet compatible.
** Includes reference well(s).

Precision Plus Protein standards are sold under license from Life Technologies Corporation, Carlsbad, CA, for use only by the buyer of the product. The buyer is not authorized to sell or resell this product or its components.

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