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VSBT 2026: Rethinking Viral Safety, Analytical Strategy, and the Path to BLA
How evolving regulatory expectations for viral safety testing and early analytical decisions are reshaping biologics development
The 2026 Viral Safety & Biotesting Summit (VSBT) arrived at a moment of inflection for biologics and advanced therapies. Regulatory frameworks are shifting, analytical strategies are under increasing pressure to move faster, and long-standing assumptions around testing, outsourcing, and preclinical models are being reexamined.
Bringing together perspectives across viral safety and what we refer to as "biotesting"—the broader ecosystem of analytical, bioanalytical, and quality control testing that underpins biologics development—the Summit reinforced a clear message: these disciplines are no longer downstream activities. They are central, strategic enablers of development speed, product quality, and regulatory success, provided they are designed early and executed with intent.
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FDA Policy Shifts: Acceleration Meets Uncertainty
Kimberly Benton, PhD, Master Principal and Head of Regulatory at Dark Horse Consulting, opened with a candid assessment of recent FDA policy changes impacting advanced therapies. Against a backdrop of leadership turnover, organizational restructuring, and workforce reductions, the agency is advancing reforms aimed at accelerating review timelines and increasing public visibility—often with uneven trade-offs.
Among the most closely watched initiatives is the Commissioner's National Priority Voucher (CNPV) program, which proposes significantly compressed review timelines for select BLAs and NDAs. While aligned with industry calls to accelerate access for high-impact therapies, its execution raises practical questions. The use of senior leadership panels in place of traditional review teams, limited transparency around selection criteria, and restrictions on voucher transferability introduce new strategic considerations for sponsors.
Benton also highlighted a broader paradox in the agency's transparency agenda. While the FDA has expanded public-facing communications through podcasts, videos, and the publication of complete response letters, other avenues for scientific exchange, including advisory committees and conference participation, have declined, narrowing opportunities for dialogue.
For cell and gene therapy developers, focus remains on the plausible mechanism pathway, particularly for rare diseases where randomized trials are not feasible. While this pathway offers flexibility in clinical evidence requirements, CMC expectations remain unchanged, reinforcing the need for early manufacturing and analytical rigor, even in highly constrained development settings.
Crisis-Driven Innovation: Lessons from COVID-19 Testing at Scale
Irina Aranovich, Research Coordinator and Lab Manager at Rutgers University, offered a practitioner's perspective on rapid assay development during the COVID-19 pandemic. Her experience demonstrated what is possible when scientific expertise, regulatory flexibility, and operational urgency align.
In the absence of commercial kits and with limited access to positive controls, her team developed a validated saliva-based qPCR testing pipeline from first principles spanning sample collection, automation, data interpretation, and reporting. Within weeks, the assay became the first saliva test to receive FDA emergency use authorization.
Equally important was the operating model underpinning this effort. Redundant workflows, cross-trained teams, and flexible automation ensured continuity under severe supply and staffing constraints. These principles later enabled high-throughput scaling, pooled testing strategies, and the successful deployment of a clinical testing lab at Princeton University.
The broader takeaway was clear: scalable viral testing depends as much on system design and operational resilience as it does on assay development.
Quality and Analytical Ownership in a Heavily Outsourced Environment
As outsourcing continues to expand across analytical and QC testing, several sessions examined where sponsor-CRO partnerships succeed—and where they falter.
Naymisha Patel, SVP of Quality at Tenaya Therapeutics, framed quality as a technical discipline rather than an abstract principle. In method transfers, she noted that sponsors often prioritize capacity and cost while underestimating the importance of technical maturity, modality-specific expertise, and tacit process knowledge. Without capturing these elements, method transfer risks becoming a transfer of uncertainty.
Gail Ferency, Senior Director of Analytical at Charles River, extended this perspective to large and complex molecules. As analytical methods are introduced earlier in development and molecular complexity increases, assumptions of standardization frequently break down. Even minor formulation differences can significantly increase analytical burden—particularly when CROs are engaged late and critical quality attributes have already been defined.
Across both perspectives, a consistent recommendation emerged: early, structured engagement with analytical partners—combined with clear definition of roles, ownership, and success criteria—is essential to avoiding delays and rework.
Phase-Appropriate Analytical Strategies: Designing for the Road to BLA
Another workshop at VSBT 2026 was dedicated to examining how analytical strategies must evolve across the development lifecycle, from early characterization through to commercialization.
Using the "road to BLA" as a framework, the session positioned biologics analytical testing as a continuous lifecycle, encompassing analytical target profile definition, method development, qualification, validation, transfer, and ongoing performance monitoring. The discussion reinforced that analytical approaches must be aligned to development stage, product knowledge, and risk.
In early development, where product and process understanding remain limited, the focus is on fit-for-purpose method qualification—using flexible, often platform-based approaches to demonstrate suitability and generate insight. As development progresses, expectations shift toward increased rigor, requiring methods to demonstrate specificity, accuracy, precision, linearity, and robustness in line with ICH Q2(R2) ahead of regulatory submissions.
Speakers also highlighted recurring challenges that can delay programs if not addressed early, including compressed timelines, incomplete physicochemical characterization, complex sample matrices, limited availability of reference standards, and evolving regulatory expectations. Additional considerations such as method transfer, assay comparability, and potency assessment were identified as critical inflection points as programs scale.
A central takeaway was the importance of early analytical strategy design. Decisions made at the outset—particularly around assay selection and analytical target profiles—have lasting implications for validation readiness, transferability, and lifecycle performance.
The session underscored a broader shift: biologics analytical testing is no longer a downstream validation step, but a strategy-led discipline that underpins development speed, process control, and regulatory confidence.
Faster Release Without Compromising Control
From a manufacturing and supply chain perspective, Prem Ramiya, SVP at Aurinia Pharmaceuticals, addressed the growing need to accelerate clinical release timelines while maintaining compliance and patient safety.
For small and mid-sized biotechs—particularly those developing autologous or short-shelf-life therapies—traditional release models are increasingly misaligned with clinical realities. Ramiya outlined strategies to compress release timelines, including recombinant endotoxin testing, rapid microbiological methods, process analytical technologies, and advanced spectroscopic tools.
However, he emphasized that technology alone is insufficient. Meaningful gains depend on cross-functional integration across manufacturing, QC, and QA, supported by digital systems that reduce handoffs and eliminate manual bottlenecks.
The conclusion was pragmatic: speed and efficiency are outcomes of well-designed analytical and quality systems, not trade-offs against them.
NAMs and Biomimicry: Redefining Preclinical and Viral Safety Testing
Looking ahead, Carmen Sweeney, Director of Scientific Portfolio Management at Charles River, explored how New Approach Methodologies (NAMs) are reshaping expectations for preclinical and viral safety testing.
As advanced modalities challenge the predictive limits of traditional animal models, developers and regulators are increasingly turning to human-relevant systems grounded in biomimicry. Organ-on-chip platforms, 3D tissue models, and molecular NAMs are enabling more mechanistic and decision-relevant insights, including in areas such as immunogenicity, pyrogen testing, and adventitious agent detection.
Recent FDA guidance reflects growing regulatory openness, emphasizing fit-for-purpose validation, biological relevance, and robustness. While adoption remains uneven, momentum is building, particularly among mid-sized biotech companies seeking faster, more predictive, and ethically aligned development pathways.
A Converging Signal for the Industry
Taken together, the discussions at VSBT 2026 point to a defining moment for viral safety and biologics analytical testing. Regulatory acceleration, increasing analytical complexity, and evolving methodologies are converging—placing greater emphasis on early strategy, cross-functional alignment, and scientifically grounded decision-making.
For developers navigating this landscape, success will depend on embedding analytical and quality strategy early, aligning scientific rigor with development pace, and ensuring that speed, control, and regulatory confidence are designed into the program from the outset.