Development and performance of an HCP quantification method at Lonza using the Gyrolab® xPand
Host cell proteins (HCPs) are one of the major part of process-related impurities during manufacturing of protein-based biopharmaceuticals. They are considered a critical quality attribute (CQA) due to their potential immunogenicity and impact on product stability. Typically HCPs are routinely monitored by ELISA commercial kits, whose performance primarily relies on the capability of the employed anti-HCP antibodies to cover HCPs. This method is reliable for early phases projects but does not provide a full coverage of the total population of HCP. In addition, ELISA method can be time consuming and laborious.
Lonza IBEX uses Xceed cell line as a platform for Process development. They generated antibodies against HCPs of this specific cell line to reach an optimal and precise quantification of HCP impurities. Lonza then developed an HCP quantification method using the Gyrolab® xPand as a semi-automated platform technique. With specific Gyrolab Bioaffy™ CDs and method generated by Gyros Protein Technologies, they managed to obtain high working range and high sensitivity in the low-concentrated part of the standard curve. Finally, we compared performance results in HCP quantification between ELISA and Gyrolab xPand methods showing similarity for most of their Downstream in-process samples.
This webinar was presented during Downstream Processing & ViralSafety Digital Week hosted by Informa Connect on May 27, 2021.