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NGS, ICH Q5A (R2), and the Future of Viral Safety: Reflections from the 2025 Viral Summit
Viral Safety & Viral Clearance Insights and Observations from Industry Thought Leaders and Regulators
The 2025 European Viral Safety and Viral Clearance Summit, held in Cologne, Germany, offered a practical and candid forum for examining how the biopharmaceutical industry is responding to ongoing changes in viral safety standards. With regulatory expectations evolving under the revised ICH Q5A (R2) guideline and broader interest in integrating next-generation sequencing (NGS) into routine quality control workflows, the event provided timely discussion around both the technical promise and the operational realities of implementing modern viral safety tools.
Bringing together regulators, developers, contract testing organizations (CTOs), and manufacturers, the two-day summit centered on a shared question: how ready is the industry to modernize viral safety testing, and what’s still in the way?
ICH Q5A (R2): Welcome Clarity, Persistent Ambiguity
Several sessions, including a focused panel discussion on Day 1, examined the implications of the revised ICH Q5A (R2), which formally encourages the use of alternative methods, including molecular assays, to replace traditional in vivo tests.
While speakers largely welcomed the update, many noted that certain areas remain vague, particularly around the replacement of in vitro and PCR-based assays.
Denise Teber (Charles River) highlighted that while the guidance provides flexibility, it stops short of setting clear thresholds for when and how new methods can be accepted: "It's not as clearly worded as it is for the in vivo test. That's something clients are still cautious about."
Dr. Astrid Müller (Paul Ehrlich Institue), contributing a regulatory perspective, added that the guideline’s principle-based structure is deliberate, designed to accommodate innovation without prescribing specific techniques. But she acknowledged the trade-off, suggesting that the openness is intentional, but that it also means regulators and industry need to talk more, not less.
Panel Discussion: Barriers to Adoption
The Day 1 panel, moderated by Dr. Horst Ruppach (Charles River), offered one of the clearest assessments of the current state of NGS adoption. While the scientific case for NGS is widely accepted and validation data continue to accumulate, panelists agreed that adoption remains cautious, particularly in late-stage development. Jens Schmidt (Takeda) underscored the central dilemma: even when NGS may offer a better or more comprehensive solution, uncertainty around regulatory acceptance makes it a difficult choice for programs approaching licensure. In such high-stakes settings, risk aversion often outweighs innovation.
There was also broad consensus that the greatest source of hesitation remains with bioinformatics, the interpretive side of NGS data analysis. Regulators, developers, and CROs acknowledged that despite maturing pipelines and validation protocols, the complexity of bioinformatics continues to create a trust gap.
Next-Generation Sequencing: Expanding Role, Incremental Gains
In parallel sessions, speakers shared applied examples of NGS implementation across quality control contexts. One presentation led by Amina Cherif Louzani (PathoQuest) traced how NGS has moved from a supplementary technique to a core component of viral safety strategies, with regulatory agencies increasingly accepting it not only as a replacement for in vivo testing, but as a broader platform capable of covering multiple assays. The shift, Cherif Louzani suggested, reflects both growing confidence in the technology and a more constructive regulatory dialogue around validation – one that focuses less on proving equivalence to legacy methods and more on demonstrating risk-based fit-for-purpose design.
Yet even among strong advocates of NGS, the prevailing view was that uptake will be uneven. The technology's sensitivity and broad-spectrum capabilities are increasingly proven, but its role in routine testing will likely continue to expand gradually, driven by case-by-case validation, comfort with analytics, and regulatory precedent.
Platform Purification and Process Challenges
Other sessions spotlighted the realities of process development, particularly for complex or unconventional biologics. One case study presented by Bastian Budde (Bayer AG) explored viral clearance validation for difficult-to-purify therapeutic proteins, emphasizing the need to revisit standard assumptions when dealing with atypical molecular structures or matrices.
Budde argued that platform strategies remain viable in these contexts, but only if they are applied flexibly, with a willingness to adapt established steps to new challenges. The presentation stood out for its pragmatic approach, offering a grounded contrast to more policy-oriented sessions.
Viral Vectors and Emerging Modalities
Advanced therapy medicinal products (ATMPs), including viral vectors and allogeneic cell therapies, also featured prominently, particularly in discussions around viral risk mitigation when traditional clearance steps are not technically feasible. In these cases, orthogonal detection methods such as NGS are increasingly being leveraged not just as replacements, but as intentional design features.
One industry newcomer, representing a company entering life sciences from adjacent sectors, reflected on the shared challenges of applying established purification expertise to novel modalities. For her, the summit's value lay equally in the technical content and in the peer exchange – a reminder that innovation in this space is as much about community as it is about capability.
Takeaways and Perspective
While much of the summit focused on future-facing technologies, the discussions were firmly grounded in day-to-day operational and regulatory decision-making. The overall tone was measured: optimism about where the field is going, tempered by realism about the complexity of getting there.
In summarizing the event, Dr. Horst Ruppach pointed to the productive tension that continues to shape viral safety, emphasizing during moderation that NGS has proven itself. But proving a tool works and integrating it into global regulatory frameworks are two different things. What we need now is accumulated experience, harmonized expectations, and more willingness, on all sides, to make decisions based on data, not habit.
Continuing the Conversation
Participants emphasized the importance of keeping the conversation moving. Content from the 2025 summit is available as recordings, slide materials, or posters. Previous years' content also remains a useful reference, particularly for tracking how positions on molecular methods and viral safety policy have evolved over time.
While adoption of new technologies remains uneven, the summit reinforced that change is not theoretical. It is already underway in pockets, through pilots, and increasingly in regulatory submissions.
As the viral safety field evolves, events like this provide a space not just to hear the latest updates, but to test assumptions, ask harder questions, and share the realities of implementation.
If you would be interested in joining a future summit, pre-registration is now open: [email protected].