HCP Coverage Analysis in Biologic Purity Checks

If you’re involved in biologics development, you know that purity isn’t just a regulatory box to check—it’s a cornerstone of safety, efficacy, and commercial success. One area where this is especially true is in Host Cell Protein (HCP) analysis. When left unmonitored, HCPs can compromise the integrity of your biologic, and worse, provoke immune responses in patients. That’s where HCP coverage analysis plays a critical role. It ensures your HCP assay—often an ELISA—is robust enough to detect a wide range of unwanted proteins derived from the host organism used in production. You’re not just validating a test. You’re safeguarding your product, your patients, and your compliance profile. Let’s walk through the key aspects of HCP coverage analysis, how to apply them in real-world biologics development, and how to avoid the common pitfalls that can derail product release or lead to failed audits. What Is HCP Coverage and Why Does It Matter? As you manufacture biologics—wheth...