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Showing posts from May, 2025

HCP Coverage Analysis in Biologic Purity Checks

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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...

Protein Concentration SDS PAGE for Accurate Profiling

If you're in a lab setting—whether academic, industrial, or clinical—getting accurate data from your protein analysis is non-negotiable. You’re likely measuring protein concentration for various applications, from drug development to food quality control. But are you ensuring precision? If not, you're risking inconsistent results, missed targets, and possibly failed experiments. That’s where SDS PAGE (Sodium Dodecyl Sulfate–Polyacrylamide Gel Electrophoresis) becomes your go-to tool. Used effectively, it gives you clear, reproducible profiles of protein concentration and molecular weight, ensuring your data tells the truth every time. Let’s break it down so you can apply SDS PAGE confidently to your next protein concentration assessment—and finally get the accurate profiling you’ve been aiming for. Why You Need Accurate Protein Profiling You already know that proteins play a central role in biological processes. But unless you quantify them precisely, you’re working wit...