Do you want to analyze the process-related residual proteins in your drug substance?
We quantify specific proteins that are utilized in the manufacturing process to produce the protein of interest. Down-stream purification aims to reduce these process additives in the drug substance, but standard analyses are not able to detect these trace amounts. For instance, the protein process residuals include growth factors, Benzonase nuclease, Protein A, enzymes for site-specific PEGylation, aminopeptidase, etc.
You can use the results for:
- FDA/EMA documentation of process-related residuals in final drug substance.
- Evaluation of clearance throughout purification steps.
- Process validation and establishment of batch acceptance criteria.
Alphalyse offers analysis development for your residual of interest, and analysis of both final drug substance and process samples. Above all, we perform low-to-sub ppm detection along with identification and quantification of key residual proteins.
The analysis includes:
- 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 also quantification of residual proteins. What is SWATH? >>
- Finally, you receive a report with the identified and quantified residual protein in each sample
Send us a description of your project and we will be glad to discuss it with you.