Back To Basics: Understanding And Testing For Process-Related Impurities

In biopharmaceutical manufacturing, the pursuit of therapeutic purity is a continuous challenge. Process-related impurities, ranging from host cell proteins and DNA to leaching from Protein A resins, are inherent byproducts of the production process. If left unmonitored, these contaminants can compromise the safety and efficacy of the final biologic, potentially triggering adverse immune responses in patients. Effective management requires a robust analytical strategy that prioritizes early detection and rigorous quantification.

By establishing a clear understanding of how these impurities originate and how they behave during downstream processing, manufacturers can better optimize purification steps. Utilizing sensitive, phase-appropriate assays ensures regulatory compliance and maintains the integrity of the drug substance. Protecting patient health depends on this foundational commitment to purity. Explore the fundamental principles of impurity testing and the methodologies used to secure the manufacturing pipeline in the full article.