Process-related residual proteins
- Document process-related residuals in final drug substance
- Evaluate clearance throughout purification steps
- Validate process and establish acceptance criteria
Do you want to monitor residual proteins added during manufacturing?
Common process residuals include added growth factors, Benzonase® Nuclease, Protein A, enzymes for site-specific PEGylation, aminopeptidase, etc. Downstream purification aims to reduce these process additives in the drug substance, but standard analyses cannot detect trace amounts.
Mass spectrometry can quantify specific proteins that are utilized in the manufacturing process.
Alphalyse offers analysis development for your residual protein of interest, in both final drug substance and process samples with low-to-sub ppm detection limit.
- Assay setup and sample analysis for specific residual protein in your pharmaceutical
- LC-MS analysis in a robust microflow HPLC coupled online to the Sciex TrippleTOF 6600 mass spectrometer
- SWATH LC-MS for reproducible identification and quantification of residual proteins
- Report with the identified and quantified residual protein in each sample