Bio-Rad Laboratories has launched the new Biologics Analysis Workflow for faster, easier and more reproducible purity assessment of protein-based therapeutics in cGMP-regulated environments.
The Biologics Analysis Workflow combines the release of several new products — the GS-900 calibrated densitometer, Image Lab 5.0 software and QC Colloidal Coomassie stain — with Bio-Rad’s Criterion precast gels and Precision Plus Protein standards.
The Biologics Analysis Workflow consists of the following steps:
1. 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.
2. 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.
3. Visualise 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).
4. Analyse results using the new Image Lab 5.0 software. Designed to meet US FDA 21 CFR part 11 compliance requirements, Image Lab automates gel analysis, saving time and ensuring consistency between runs.
A scientist at a global contract research organisation (CRO) explains that the ability to calibrate the GS-900 system prior to scanning and take the optical density down to zero offers a significant advantage regarding compliance, because the GS-900 densitometer covers the density range that the CRO reports. He adds that Image Lab software facilitates compliance by allowing easy creation of the sorts of custom data reports that auditors look for.
