Standard analyses do not detect trace amounts of protein process additives, otherwise known as residual proteins. Examples include growth factors, Benzonase nuclease, Protein A, enzymes for site-specific PEGylation, etc.
Instead, you can now use a customized LC-MS assay developed by Alphalyse. The assay will detect residual proteins of interest, including Protein A – in both your final drug substance and process samples – to help you optimize your drug product development.
Advantages of the new analysis include:
- The ability for low-to-sub ppm detection.
- Identification and quantification of key residuals.
You can use the results for
- FDA/EMA documentation of process-related impurities, like Protein A, in the final drug substance.
- Evaluation of clearance throughout all purification steps.
- Process validation and establishment of batch acceptance criteria.
Through Alphalyse, you can now get help with analysis development for your residual of interest and residual protein analysis of both final drug substance and process samples. Above all, we help you perform low-to-sub ppm detection along with the identification and quantification of key residual proteins.
Find out more about our process-related impurities analysis here – or contact us for a free consultation by phone or web conference.
You can also check out this blog post on the documentation of a process-related impurity or watch a short video describing the types of residual proteins we can analyze with the new method.