The Biologics Analysis Workflow is a suite of products designed and validated to assess the purity or identity of biological products in a cGMP regulatory environment. The Biologics Analysis Workflow provides:
- Increased throughput
- Simplified, sensitive gel staining
- Accurate and reproducible imaging
- Easy data analysis
The Biologics Analysis Workflow includes a set of integrated protein electrophoresis solutions for each step of the workflow:
Step 1: Separate samples
Criterion™ TGX™ precast gels — increased throughput with fast run times and more sample loading wells
The unique properties of TGX chemistry reduce run times to as little as 20 minutes. These gels have a 1-year shelf life and utilize the standard Laemmli buffer system. The midi-sized Criterion format allows you to load up to 26 samples while maintaining the required resolution. Additionally, the characteristic upper buffer chamber reduces the amount of running buffer required.
Step 2: Stain proteins
QC Colloidal Coomassie stain — highly sensitive, reliable, end-point stain designed for quantitative analysis of proteins
QC Colloidal Coomassie stain enables the detection of nanogram levels of protein. The colloidal chemistry improves the protein-to-dye binding ratio, reducing background staining and improving sensitivity. QC Colloidal Coomassie stain is an end-point stain that was designed and optimized for quantitative analysis with the GS-900™ densitometer. The stain is ready to use without mixing or the addition of other reagents. The stain is formulated with ethanol instead of methanol, eliminating the need for hazardous waste disposal.
Step 3: Visualize proteins
GS-900™ calibrated densitometer — reproducible imaging of protein gels, blots, and film across a wide dynamic range
To ensure the accuracy of each scan, the GS-900 calibrated densitometer contains internal optical density tablets that are scanned and used for calibration before each run. The calibration of the GS-900 densitometer can be validated with the GS-900 calibrated densitometer installation and qualification kit, which utilizes an external target to confirm accuracy of the internal target, ensuring the accuracy and reproducibility of the GS-900 densitometer. With red/green/blue tricolor CCD technology, the GS-900 calibrated densitometer enables the imaging and quantitation of film, blots, and gels stained with a wide variety of stains. The wide dynamic range permits the quantitation of proteins from 0–3.4 OD.
Step 4: Analyze results
Image Lab™ image analysis software — effortless analysis of samples with an intuitive, user-friendly interface
Gel analysis is greatly simplified with Image Lab software. The ability to automate analyses saves time and ensures consistent analysis from run to run. Image Lab software includes detailed tutorials and requires no previous imaging experience to produce optimum gel and blot images. The flexible system allows users to easily modify analysis settings to match SOPs and fine-tune band detection, background level, and other settings. Image Lab software makes reporting easy with the ability to create customized reports and meets regulatory requirements with an optional 21 CFR Part 11 module.