Recent updates to ICH guidance and advancements in LC-MS technology are reshaping how biopharmaceutical teams analyze and quantify host cell proteins, offering deeper insight beyond traditional ELISA methods.

Implementing ICHQ14 represents a paradigm shift in analytical method development and real-time release strategies. In this post, I share insights from a recent industry publication and reflect on how blending traditional frameworks with ICHQ14 principles can pave the way toward stronger compliance and innovation in pharmaceutical analytics.

Host Cell Proteins (HCPs) remain a major focus in biopharmaceutical manufacturing. In this article, we highlight a recently published industry review on HCP clinical safety and explore how evolving technologies are reshaping impurity profiling and risk assessment.