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Viral Clearance & Viral Safety: Industry Trends & Key Events Sandra Zucchet, MSc Scientific Expert, Viral Clearance Charles River Amina Cherif Louazani, PharmD, PhD Manager, Viral Safety and Regulatory Affairs PathoQuest BIOPHARM INTERNATIONAL ® : Sandra, what major topics in viral clearance are dominating the industry at the moment, and what challenges does the field have to face moving forward? SANDRA ZUCCHET, MSc: Updates to the ICH Q5A guidelines [ICH Q5A(R2)] 1 have had a direct impact on viral clearance strategies. One of the major developments is the shif t towards continuous manu- facturing. We have well-established viral clearance strategies for traditional batch approaches, but adapting these to contin- uous manufacturing is a challenge. For ex- ample, batch processing typically involves well-characterized and consistent protein and impurity concentrations. Continuous manufacturing can lead to fluctuations in these concentrations, including transient peaks. It is essential to understand how such variations influence the viral clear- ance capacity of individual process steps throughout a continuous process. A key challenge for manufacturers will be designing appropriate viral clearance studies—determining whether batch- mode studies can still be used, and if so, how to justify the selected parameters. Additionally, understanding how these variations affect the viral clearance capa- bility of each process step will be critical. Advanced therapy medicinal products are also an important area of focus. Newer modalities such as cell therapies, gene therapies, and the assurance of virus safety for these product types is a hot topic. Traditional viral clearance strate- gies cannot be applied to cell therapies. Viral vectors used in gene therapies also pose challenges in terms of viral safety. Fortunately, the ICH Q5A(R2) guidelines address advanced therapies. 1 It's good that we have a regulatory framework to follow. However, challenges designing viral clearance studies for these thera- pies still exist, and we may be limited in process steps capable of inactivating or removing viruses. We are facing challenges with model virus selection due to the wide range of produc- tion systems. Additionally, there is no clear regulatory framework for IND and CTA fil- ings for these newer product types. While the ICH Q5A(R2) guidelines have brought them into scope, 1 guidance primarily ap- plies to marketing applications. The chal- lenge now is to determine the regulatory expectations for early phase viral clearance studies in support of clinical trials. A third major topic is the use of prior knowledge. With the revised ICH Q5A guidelines, there is now the possibility to leverage prior knowledge and potentially omit product-specific viral clearance stud- ies—if manufacturers can demonstrate consistent performance of processes. 1 The challenge will be in determining how to apply prior knowledge to build a robust manufacturer-specific database, and in understanding how much data is sufficient to support a general claim with- out conducting a product-specific viral clearance study. Manufacturers will need to keep up with evolving regulatory requirements, espe- cially as agencies continue to support and embrace new technologies. This is im- ASK THE EXPERT SPONSORED CONTENT SPONSORED BY ® Visit www2.criver.com/ ViralSummit2025 to register for the 2025 Viral Safety & Viral Clearance Summit to join industry thought leaders June 3-4 in Cologne, Germany.