Reliable protein quality control — compliant with ICH guidelines

The Agilent 2100 Bioanalyzer together with the Agilent High Sensitivity Protein 250 Kit offers unsurpassed speed, sensitivity and reproducibility for superior protein QC in a production-ready method. It detects and quantifies low concentrated impurities next to massive main components — down to 0.05% and below. This meets the ICH guideline Q3B (R2) on Impurities in New Drug Products!

Built on Agilent’s industry leading lab-on-a-chip platform, the 2100 Bioanalyzer offers:

• Sensitivity and linear dynamic range — silver stain sensitivity down to 1 pg/μL of labeled protein on chip and 4 orders of magnitude in linear dynamic range
• Fast results — complete automated analysis of 10 samples in 30 minutes
• Reproducibility — qualitative, user-independent and digital data
• Ease of use — standardized assay, pre-packaged reagent kits
• 21 CFR Part 11 compliance — validated reagents, software, and compliance services.

The High Sensitivity Protein 250 kit provides the first microfluidic assay for protein detection in the low picogram range. Therefore, the kit is perfectly suited to solve typical protein QA/QC questions and to comply with ICH and FDA guidelines.

Learn more about the Agilent 2100 Bioanalyzer.
Request Agilent’s Protein QC Application CD!