Welcome to BioPharmaSpec's HCP-MS Hub, an online resource which gathers together in-depth knowledge from our expert scientists to help you further understand and implement LC-MS as part of your Host Cell Protein detection strategy.
As a biopharmaceutical developer, you will be aware of the importance of monitoring Host Cell Proteins, or HCPs, throughout your process, showing that each purification step is reducing the HCP population. This importance relates to the fact that HCPs can cause immunogenicity in the patient and therefore pose a significant safety risk. It is of course likely that even after the use of several purification techniques, a low-level of HCP material will remain in the drug. Furthermore, the HCP profile is highly dependent on the process and controls applied, so it is crucial to continuously monitor the level of HCP throughout your process, but also after any changes have been made, to show clearance and also better understand your process controls.
Targeted HCP monitoring has traditionally been performed using ELISA-based tests but due to huge advances in speed and sensitivity, there are now also mass spectrometric methods available. The biggest advantage to this is that we now have more than one technique for monitoring HCPs and can therefore build orthogonality into our HCP detection strategies, providing us with greater understanding of the true HCP population in any given sample.
The BioPharmaSpec Approach to HCP-MS
In our HCP-MS Hub, we have gathered together webinars, blogs, publications and technical bulletins to help you understand how to implement HCP-MS in the most efficient way for your product and process. If you have any questions regarding this material, or you would like to talk directly to our scientists about your product and HCP strategy, please contact us. We are happy to help!
Our HCP-MS Services
Whether you are looking for speedy analysis to provide orthogonal data to your ELISA results, or a method for quantitative Host Cell Protein detection, BioPharmaSpec can help you with your LC-MS based HCP detection needs.