Better vaccine purity and consistency –
Best practice Host Cell Protein analysis by LC-MS

As regulatory standards evolve, vaccine developers face growing pressure to meet Host Cell Protein (HCP) impurity testing requirements, which are largely modeled after those for monoclonal antibodies (mAbs) – despite the fundamentally different clinical uses and patient safety concerns associated with vaccine products.

Vaccines present unique challenges due to their diverse modalities, expression systems, and limited suitability of ELISA impurity assays. The complexity of vaccines demands advanced analytical approaches, such as quantitative mass spectrometry (LC-MS), to ensure product quality, process consistency, and regulatory compliance.

In this webinar, Ejvind Mørtz, PhD, COO and Co-founder of Alphalyse, will share practical insights on:

• 2025 updates from regulatory authorities and vaccine experts
• Best practices described in USP <1132.1> on HCP analysis by LC-MS
• Real-world case studies from Alphalyse clients developing complex vaccines

Do you work with Chemistry, Manufacturing, and Controls (CMC) in vaccine development? This webinar will provide you with essential updates on the latest industry trends and evolving regulatory expectations on HCPs, along with knowledge on an analytical solution that fits any type of vaccine.