Session: Session 4

Host Cell Proteins identification and quantification inside Vaccine using HCPprofiler Kit

Biotherapeutics, molecules produced from biological systems, require rigorous purification steps to remove impurities and host cell proteins (HCP). Regulatory guidelines require pharmaceutical laboratories to monitor process-related impurities along the down stream process purification workflow.

We present here a method validation for the identification and quantification of HCPs inside a vaccine Drug Product. Sample preparation was performed using HCPprofiler kit, which was designed for the easy implementation of HCPs quantification methods in LC-MS equipped laboratories.

Results demonstrated high accuracy with quantification error ranges between 0.8 - 1.2, and excellent repeatability with CV (%) below 20% for intermediate precision. Linearity of the response was verified during a spiking study using Bovin Serum Albumin (BSA) from 35 to 20 000 ppm inside the drug product.

Data obtained during this study proved the HCPprofiler method implementation to be a robust and accurate tool for the HCPs identification and quantification inside vaccines drug products.