This May, the Minaris Advanced Testing team contributed an article to BioProcess International’s recent eBook, Process-Related Impurities: Making the Most of Purification and Analysis.
The article entitled “Optimizing Viral Clearance Studies: Practical Considerations for Detecting and Characterizing Process-Related Impurities” explores key strategies for designing and executing effective viral clearance studies in today’s evolving biomanufacturing landscape and highlights practical considerations for detecting and characterizing process-related impurities. It details how thoughtful study design and strong analytical strategies can maximize purification performance and regulatory confidence.
The insights provided are based on the many years of experience the Minaris Advanced Testing team has executing these studies and are particularly relevant for teams focused on optimizing monoclonal antibody (mAb) and AAV purification.
Throughout the article, authored by Kathleen Kenney, Director of Viral Clearance, the importance of strategically designing viral clearance studies through early alignment between process development and viral safety teams is emphasized. By fostering cross-functional collaboration at the outset, manufacturers can streamline study design, minimize the risk of repeat experiments, and generate data that are both meaningful and actionable.
Another topic that is addressed is the growing pressure to reduce cost of goods, and Kathleen outlines how companies can maintain scientific rigor and regulatory robustness without overextending resources.
Viral clearance is framed as part of a broader, risk-based approach to control viral contamination in biopharmaceutical processing.
The article further explores practical approaches to detecting and characterizing process-related impurities (PRIs) within downstream workflows, underscoring the value of integrating purification performance data with strong analytical insight. Guidance is also provided on how to generate clear, defensible data packages that meet regulatory expectations while preserving process flexibility.
Together, these insights highlight how well-designed viral clearance programs can be not only compliant, but also efficient, scalable, and aligned with modern purification strategies. Learn more about the eBook and download your copy below. Contact us to learn more about how we can help with your next study and ask the team about our flexible scheduling, accelerated timelines, and high-quality virus stock.