Industry Perspectives on Preparing Validation-Ready NGS Workflows
May 17, 2026
Alison Waterfield
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As biotherapeutic development continues to advance, biopharma organizations are increasingly focused on implementing next generation sequencing (NGS) workflows that can support evolving safety, quality, and regulatory expectations. Across biosafety testing, genome integrity, and product characterization, NGS is playing an increasingly central role in how teams generate, analyze, and interpret complex genomic data.
At the same time, industry discussions are shifting from exploratory use toward how these workflows can be prepared for broader adoption and future regulated use in validated environments. This includes aligning wet-lab processes, sequencing strategies, and bioinformatics pipelines within robust, end-to-end analysis environments.
Through its Open Forum series, Genedata brings together industry experts to share real-world experience, discuss practical challenges, and exchange insights on how GxP-compliant NGS workflows are being prepared for use across biotherapeutic R&D and manufacturing.
Highlights from the 12th Genedata Selector Open Forum on NGS Workflow Validation
On May 7, 2026, Genedata Selector hosted its 12th Open Forum Industry Workshop, bringing together speakers from AbbVie, Astellas, FUJIFILM, Amgen, Eli Lilly, and participants from over 50 leading biopharma organizations. The virtual event provided a focused forum for exchanging real-world experience and practical perspectives on preparing GxP‑validation‑ready NGS workflows for use biotherapeutic R&D and manufacturing.
During a warm welcome to the event, Thomas Hartsch, Head of Genedata Selector, set the context for the day by highlighting the rapid evolution of the regulatory landscape for NGS since 2024. He referenced key milestones including ICH Q5A (R2), the adoption of European Pharmacopoeia chapter 2.6.41, and the growing regulatory emphasis on the 3R principles. Together, these developments signal a clear shift toward replacing traditional animal‑based testing with non‑targeted NGS approaches and underscore that NGS quality control is becoming an expected component of modern biopharma workflows. Building on this context, speakers across the agenda shared practical insights into developing, validating, and scaling end‑to‑end NGS analysis environments. Presentations addressed both technical and organizational considerations, including biosafety testing strategies, characterization of critical quality attributes (CQAs), and approaches to aligning scientific flexibility with regulatory rigor. Collectively, the sessions highlighted how biopharma teams are moving beyond exploratory NGS use toward structured, validation‑ready workflows designed for long‑term use and future regulated applications.
Astellas’ Approach to Driving Safety in Cell & Gene Therapy Through NGS and Regulatory Alignment
Tracie Fradet, Associate Director of Cytogenomics at the Astellas Institute for Regenerative Medicine, shared how her team is building and expanding a validated NGS platform to support safety testing in CGT. Her talk traced key milestones in establishing NGS infrastructure, qualifying and validating methods, and extending applications for adventitious agent detection and variant analysis.
Tracie emphasized the importance of early and ongoing engagement with health authorities, highlighting how regulatory interactions actively inform method development, validation strategy, and platform evolution. She also discussed how structured system life-cycle management supports scalable, regulator‑ready adoption of NGS.
From Science to Compliance: Effective Validation of Genedata Selector
Giuseppe Semplicio, Scientific Account Manager at Genedata, discussed how NGS workflows are transitioning from exploratory R&D use into regulated manufacturing and control environments. He outlined why validation becomes critical as NGS begins to support safety‑critical and regulatory decisions.
Giuseppe described the challenge of validating scientific software at scale, where flexibility, automation, and multiple use cases must be balanced with regulatory rigor. He introduced a structured, two‑tier validation approach that separates platform validation from use‑case‑specific workflow qualification, enabling scalable validation while preserving scientific flexibility and preparing NGS analysis environments for compliant, long‑term use.
AbbVie’s Approach to In-House NGS-Based Adventitious Virus Detection for Biosafety Testing
Sakthi Balaji, Senior Scientist II at AbbVie, presented her team’s approach to developing an in‑house adventitious virus detection assay using high‑throughput sequencing. Her talk focused on why NGS is being adopted as part of modern viral safety strategies, including its broad detection capability and suitability for evolving regulatory expectations.
Sakthi shared results from pilot and spike‑in studies using viral nucleic acid mixes, inactivated viruses, and live viruses to assess assay sensitivity and workflow performance. She also outlined next steps toward validation, including reproducibility testing, threshold setting, and planned use of WHO reference panels.
Building NGS‑Based Workflows for Critical Quality Attribute Characterization in Cell and Gene Therapy at FUJIFILM
Andrew Hillhouse, Principal Scientist at FUJIFILM Biotechnologies, shared how his team is developing structured, NGS–based workflows to support characterization of CQAs in cell and gene therapy (CGT). His presentation focused on applying NGS across identity, genome integrity, and biosafety testing, with an emphasis on moving from isolated assays toward coordinated, end‑to‑end workflows.
Andrew highlighted how modular workflow design enables flexibility across assay types and product modalities, while maintaining consistency in data analysis and interpretation. He also discussed how standardized bioinformatics pipelines and automated Playbooks help manage the scale and complexity of NGS data as adoption expands across programs.
Panel Discussion
The second half of the Open Forum brought together all speakers and guest panelists for a live panel discussion moderated by Christoph Bredack, Business Account Manager at Genedata. The conversation focused on how biopharma organizations are ensuring that NGS-based decisions remain repeatable, robust, and defensible over time in regulated environments.
Panelists examined what must stay consistent across people, technologies, and operational pressure to build and maintain regulatory trust. They shared practical perspectives on documenting evidence, defining validation boundaries, and translating expert judgment into repeatable practice without slowing scientific progress. The discussion also explored the role of AI as a supporting tool, emphasizing its potential to improve consistency, documentation quality, and efficiency, while keeping responsibility and decision‑making firmly with human experts. Attendees contributed their views through live Q&A, adding valuable real‑world context to the discussion.
Event Summary: Preparing GxP-Validation-Ready NGS Workflows and Insights from Live Q&A Sessions
Each presentation was followed by a lively and engaging Q&A session, with thoughtful questions from attendees spanning validation strategy, workflow design, and regulatory readiness. Speakers addressed the questions live, making the event highly interactive and informative. In summary, the 12th Genedata Selector Open Forum highlighted how biopharma organizations are actively preparing NGS workflows for broader adoption. Across sessions and discussion, a consistent theme emerged: the importance of building robust, end‑to‑end, GxP‑validation‑ready NGS analysis environments that can support future regulated use.