Alphalyse is analysing many viral vector based products, including Vero cells and many exotic cell lines used in vaccines. The acceptance limits are decided on a case-by-case basis depending on patient population, severity, dosing, and CMC conditions.

Ejvind Mørtz, PhD, Co-Founder & COO of Alphalyse in Denmark, discusses the regulatory expectations for HCP analysis, highlighting the importance of USP <1132.1> to improve MS-based data quality. Don’t miss his presentation and expert insights at the panel discussion.

Watch the On-Demand presentation here: https://bio-qc.com/regulatory-expectations-for-your-hcp-analysis-meet-usp-1132-1-to-enhance-the-quality-of-ms-based-data/

I have no experiences with viral vaccines, but generally speaking, acceptance limits evolve throughout development, as more information about batch, process, as well as analytical, variation becomes available. An acceptance limit with regard to the total load of residual HCPs could be a good starting point that could evolve to either a tightened specification towards later stage(s) of development, or into an acceptance limit for individual HCPs of concern by LC-MS.

Don’t miss Eef Dirksen, Director of Analytical Development and Quality Control at Byondis (Netherlands), who discusses regulatory expectations for HCP analysis and highlights the importance of USP <1132.1> in improving MS-based data quality.

Watch the On-Demand presentation here: https://bio-qc.com/regulatory-expectations-for-your-hcp-analysis-meet-usp-1132-1-to-enhance-the-quality-of-ms-based-data/