Issue link: https://www.e-digitaleditions.com/i/1535562
ASK THE EXPERT SPONSORED CONTENT ® trol (QC) testing for biologics through NGS. Within this space, I support customers who are changing their QC strategies to implement NGS, either as a replacement or as a supplement to other assays used for viral safety. This is all important, as we've seen a transition of NGS from an investiga- tive tool for evaluating the viral safety of certain products to being recog- nized and accepted by both regu- lators and the industry as an actual alternative in viral safety testing. BIOPHARM INTERNATIONAL ® : What are the regulatory and industry changes impacting viral safety testing? AMINA CHERIF LOUAZANI, PharmD, PhD: From a regulatory standpoint, the implementation and adoption by the regulators of the ICH Q5A(R2) guidance has been a defin- ing moment. In this revised guideline, we have more clarity on viral safety testing and proper evaluation of novel product types. 1 As Sandra mentioned, we have new bioprocessing technol- ogies that can be implemented that require faster and more robust adven- titious virus detection very quickly. New modalities present new chal- lenges, from the viral clearance per- spective. This calls for stronger secu- ritization and more robust viral safety testing strategies for manufacturers. The revised ICH Q5A guidance rec- ommends the use of broad molecular technologies, like NGS, as tools for adventitious virus detection, provided they are properly validated. 1 We've also seen greater flexibility from au- thorities like the FDA and EMA in al- lowing platform approaches, enabling the application of prior knowledge in viral safety testing. In terms of harmonization efforts, es- pecially in the past year, we've seen significant progress with the publica- tion of the draft European Pharma- copeia Chapter 2.6.41. This chapter clearly outlines the use of NGS for vi- rus detection, providing guidance on how to properly validate these meth- ods. It also defines performance crite- ria and offers alignment on designing and validating these technologies. 2 In parallel, from an industry perspec- tive, we've seen a strong push to im- plement these new technologies. This was highlighted by the European Fed- eration of Pharmaceutical Industries and Associations, which, in its position paper, advocates for the adoption of NGS as a tool for detecting adventi- tious viruses. 2 This marks the beginning of a new era in viral safety, where we will have the ability to deliver more ro- bust and secure products for patients. BIOPHARM INTERNATIONAL ® : Dr Cherif Louazani, what topics are you presenting at the summit, and why are these so important to you? AMINA CHERIF LOUAZANI, PharmD, PhD: I'll be presenting the regulatory acceptance of NGS for ad- ventitious virus testing, with a particular focus on our experience over the past few years, with the implementation of ICH Q5A(R2). The presentation will highlight the application of NGS across various product modalities, the types of products we've tested for our custom- ers, and how we're supporting different replacement strategies using NGS. This is an important topic for me, not only from a scientific perspective—it's exciting to see how we are using more innovative technologies that we know are more robust in viral safety testing—but in the context of new, highly-personalized therapies, in the context of more complex processes that need better coverage in terms of virus detection, implementing NGS is a way to safeguard, from my per- spective, patient safety. Broadening the implementation of this approach will help accelerate access to innova- tive therapies that are safer and offer greater reassurance for patients. I would also add that we're truly at a turning point—validated technol- ogies are now in place, and regula- tory frameworks are becoming more aligned than ever before. For those of us who are working in this space, this is an opportunity to modernize testing approaches and provide therapies with better safety assurance. REFERENCES 1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. Published November 1, 2023. Accessed April 22, 2025. https://database.ich.org/sites/default/files/ ICH_Q5A(R2)_Guideline_2023_1101.pdf 2. European Federation of Pharmaceutical Indus- tries and Associations (EFPIA). EFPIA Comments on European Pharmacopoeia Chapter 2.6.41: High-Throughput Sequencing for the Detection of Viral Extraneous Agents. Published June 2024. Accessed April 22, 2025. https://www.efpia.eu/ media/er3f52xp/efpia_comments_pheur2_6_41_ ngs.pdf