To ensure drug safety and efficacy, multiple critical quality attributes such as purity, fragmentation, aggregation, and post-translational modifications need to be well-characterised and monitored. Assays like CE-SDS and cIEF offer automated and quantitative quality assessments of protein therapeutics and are routinely used throughout the drug development process and as a product release test. Adding native fluorescence detection elevates these gold standard assays to improve confidence in data and accelerate the drug development pipeline.
- Reduce the noise – see low abundant peaks more clearly with a clean background. Higher signal intensity and a stable baseline are obtained through reduced stray light, higher transmissions, and eliminated background media interference in the capillary.
- Accelerate your data analysis – a stable baseline means faster, more confident, and easier peak integration and accurate results.
- Get to the data quickly – simplify sample preparation and eliminate the need for complex protein-dye conjugation. Native detection relies on the naturally existing aromatic amino acids in the protein, eliminating the dye labelling process.
- Increased sensitivity – achieve up to 10x increase in sensitivity for CE-SDS and cIEF assays.
“We frequently hear from our customers, that managing large sample sets with limited material and tight timelines is a challenge. Native fluorescence detection on the BioPhase 8800 system addresses this challenge by providing fast, accurate analysis, which is critical for advancing the best candidates in development. We’ve already seen it produce notable time savings, improved precision, and better confidence when identifying new impurity peaks and low-abundant species,” said Jose Castro-Perez, Vice President, Product Management at SCIEX.