Bioradiations Staff
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
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.
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 |
| 1610396 |
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) |
| Stain | |
| 1610803 | QC Colloidal Coomassie Stain, 1 L |
| Buffers | |
| 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 |
 18-Well 30 µl |
 26-Well* 15 µl |
 Prep+2-Well*, ** 800 µl |
 IPG+1-Well** 11 cm IPG Strip |
|
| 7.5% Resolving Gel |
567-1023 | 567-1024 | 567-1025 | — | — |
| 10% Resolving Gel |
567-1033 | 567-1034 | 567-1035 | — | — |
| 12% Resolving Gel |
567-1043 | 567-1044 | 567-1045 | — | — |
| 18% Resolving Gel |
567-1073 | 567-1074 | 567-1075 | 567-1072 | 567-1071 |
| 4–15% Linear Gradient |
567-1083 | 567-1084 | 567-1085 | 567-1082 | 567-1081 |
| 4–20% Linear Gradient |
567-1093 | 567-1094 | 567-1095 | 567-1092 | 567-1091 |
| 8–16% Linear Gradient |
567-1103 | 567-1104 | 567-1105 | 567-1102 | 567-1101 |
| 10–20% 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.