Issue link: https://www.e-digitaleditions.com/i/1535562
portant to ensure they meet regulato- ry requirements while minimizing the risk of their filings being rejected. BIOPHARM INTERNATIONAL ® : Do you already see trends in changing viral clearance study designs/scopes based on the ICH Q5A(R2) guidance? If so, what are the main changes you are observing and where do we still see reservation? SANDRA ZUCCHET, MSc: Although the ICH Q5A(R2) guidance was signed off by the ICH in No- vember 2023, 1 it is still in the process of being implemented by different regulatory bodies. As a result, there is no clear-cut timeline for changing viral clearance strategies. However, we [Charles River] reviewed changes that have occurred in viral clearance study designs over the last 2 years. In regard to protein A chromatography and the use of aged resin runs, the revised ICH Q5A guidelines allow for the omission of used resin runs, 1 since there is over 20 years of prior knowl- edge demonstrating that resin capaci- ty is not impacted. Surprisingly, we did not see a shift in the percentage of projects using aged resin versus only using fresh resin, but we did see regional differences. In Europe and North America, for ex- ample, we noted a decline in projects using aged resins. In Asia, however, the number of projects testing used resin for the protein A step was main- tained. So, I think we still see regional differences. For the nanofiltration step, manufac- turers are now permitted to transfer the log reduction factor determined for the smallest model virus—typically parvovirus—to larger viruses because of the principle of size-based exclu- sion. 1 Once a filter has been shown to retain a small virus, it can be reason- ably assumed to retain larger viruses as well. Here, we see a shift away from testing MuLV (murine leukemia virus)—a relatively large virus—in viral clearance studies, toward testing only MVM (minute virus of mice), the par- vovirus, for the nanofiltration step. In general, I think manufacturers tend to be more conservative when it comes to changing well-established viral clearance strategies. Many prefer to stick with proven approaches rath- er than adopting new strategies too quickly. We've also observed regional differences in this regard. It's import- ant to keep in mind that manufac- turers often operate across multiple regions, where regulatory expecta- tions can vary significantly. That said, I believe we just need to give it another 2 or 3 years to see how this evolves. BIOPHARM INTERNATIONAL ® : Sandra, how has Charles River's Virus Safety & Viral Clearance event evolved over the years? What can we expect from the Virus Safety & Viral Clearance Summit in Cologne [Germany] this year? SANDRA ZUCCHET, MSc: The first viral clearance summit was hosted by Charles River in the US in 2016. The summit was necessary because, at the time, very few conferences addressed viral clearance topics. As the event grew, we began introducing virus safety topics and invited various stakeholders, including regulators from the FDA and EMA. This was very valuable to our attendees, and we realized that people were waiting for an event like this to be hosted in Eu- rope. And so, we hosted our first Eu- ropean viral clearance summit in 2023 in Cologne, Germany. I'm very happy to announce that the event will return there this year, in June. This year, the event includes a full day dedicated to virus safety. Here, we'll talk a lot about next-generation sequencing (NGS). We'll also host a full day dedicated to viral clearance that will include great discussions about current hot topics in the industry. This day will include presentations on the use of prior knowledge and the application of novel technologies, including the first co-spiking studies and the use of ret- rovirus-like particles as noninfectious surrogates. Our keynote speaker, join- ing us from the Paul-Ehrlich-Institut, will present on the revised ICH Q5A guidelines. These 2 days will be very intense. Afterwards, Charles River will offer attendees the opportunity to tour our facilities in Erkrath and Co- logne. This is a fantastic opportunity and I'm looking forward to recon- necting with familiar faces as well as meeting new ones at the Virus Safety & Viral Clearance Summit. BIOPHARM INTERNATIONAL ® : Dr Cherif Louazani, I understand you'll be presenting at this year's summit. Could you please introduce yourself and share a bit about your role in viral safety? Also, what major milestones in viral safety testing have occurred over the past 5 years? AMINA CHERIF LOUAZANI, PharmD, PhD: As a viral safety and regulatory affairs manager at Patho- Quest, I'm in charge of overseeing the use of our viral safety products with NGS technology to evaluate viral safe- ty status of biologics. We are a CRO specialized in providing quality con- ASK THE EXPERT SPONSORED CONTENT