Hercules, CA — July 15, 2013 — Bio-Rad Laboratories, Inc. today announced the launch of 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.
How It Works
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.
A scientist at a global contract research organization (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.
A recent comparability study by Bio-Rad demonstrates how easily labs can update their protocols to include the GS-900 system and the Biologics Analysis Workflow for compliance with FDA and other regulatory requirements.
To learn more about the Biologics Analysis Workflow and how you can seamlessly integrate the new workflow into your SOPs, visit bit.ly/BiologicsAnalysisWorkflow.
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) has been at the center of scientific discovery for 60 years, manufacturing and distributing a broad range of products for life science research and clinical diagnostic markets. The company is renowned for its commitment to quality and customer service among university and research institutions, hospitals, public health and commercial laboratories, as well as the biotechnology, pharmaceutical, and food safety industries. Founded in 1952, Bio-Rad is based in Hercules, California, and serves more than 100,000 research and industry customers through its global network of operations. The company employs approximately 7,300 people worldwide and had revenues exceeding $2 billion in 2012. Visit us at www.bio-rad.com.
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