The Biologics Analysis Workflow from Bio-Rad Laboratories is designed for more reproducible purity assessment of protein-based therapeutics in cGMP-regulated environments. The workflow combines the release of several new products—the GS-900 calibrated densitometer, Image Lab 5.0 software, and QC Colloidal Coomassie stain—with the company’s Criterion precast gels and Precision Plus Protein standards.

The Biologics Analysis Workflow consists of the following steps:

• Separate samples in only 20 minutes using Criterion TGX precast gels. The higher-throughput, mid-sized format increases reproducibility and reduces costs because fewer gels are needed.

• Stain proteins with the QC Colloidal Coomassie stain. Capable of detecting nanograms of protein, this ready-to-use stain eliminates the need for preparation, requiring no additional reagents or mixing, which results in increased reproducibility.

• Visualize proteins using the GS-900 calibrated densitometer. Autocalibration prior to each run ensures consistency and accuracy. The wide dynamic range improves purity estimates by allowing for impurity detection at low optical density (OD).

• Analyze results using the new Image Lab 5.0 software. Designed to meet U.S. FDA 21 CFR part 11 compliance requirements, Image Lab automates gel analysis, saving time and ensuring consistency between runs.

Bio-Rad Laboratories Inc., 800-424-6723, www.bio-rad.com