HCP levels in clinical batches

Do you want to quantify hcp levels in pre- or clinical batches?

Before entering clinical trials and submitting NDA or BLA, it is highly critical to determine the level of process-related impurities, like Host Cell Proteins (HCPs). 

By applying mass spectrometry, you get the complete overview of the HCP content beforehand, to potentially avoid costly delays at later-stage trial approval. Also, you can compare different clinical batches to check for manufacturing consistency. 

The method identifies and quantifies the host cell proteins in purified drug substance batches by SWATH LC-MS/MS. The analysis thus provides you with a more detailed and accurate HCP documentation than HCP ELISA. The total HCP content is measured in ng HCP/mg drug substance (ppm), and each host cell protein is identified and quantified individually.

For pure drug substance batches with low HCP levels (1-500 ppm) you receive a highly sensitive and reproducible analysis. It both delivers identification and quantification of host cell proteins down to low ppm concentrations.

An analysis of HCP levels includes:

• Optimized sample preparation for pure drug substance samples
• Spike-in of internal standard proteins (0-2000 ppm) for quantification linearity and LOD
• LC-MS peptide analysis on a robust microflow HPLC and mass spectrometer, using SWATH LC-MS/MS for reproducible HCP identification and quantification
• Report with table of total HCP and individual HCPs amounts, as well as comparison between batches

Send us a description of your project and we will contact you to discuss how you can benefit from an analysis of HCP levels.