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.

Ed Fleischer, founder of Beachside Compliance Solutions, joins The Healthy Enterprise podcast to discuss leadership, quality systems, and regulatory excellence across biotech and pharma.

Listen & Share
You can find the episode on all major platforms from here:
https://share.transistor.fm/s/940a3c69

YouTube:  https://www.youtube.com/@TheHealthyEnterprisePodcast