Advancing NGS-Based Workflows in Biopharma Development
October 2, 2026
Alison Waterfield
Next-generation sequencing (NGS) is moving beyond research applications into biopharmaceutical development, from cell line development and product characterization to biosafety testing and regulated quality control. As its role expands, the challenge is shifting from what NGS can do to how organizations can implement it reliably, at scale, and in increasingly regulated environments.
That challenge brought scientists and technology leaders together at the 13th Genedata Selector Open Forum in Lexington, MA, on September 21, 2026. The event attracted registrants from 25 biopharmaceutical organizations, including AbbVie, Sanofi, Biogen, Vertex, and Takeda. Experts from Astellas Institute for Regenerative Medicine (AIRM), Bristol Myers Squibb (BMS), and FUJIFILM Biotechnologies shared first-hand experiences of putting NGS-based workflows into practice.
Across presentations, peer discussions, posters, and demonstrations, several themes emerged around what it takes to move NGS forward in biopharma.
Four themes stood out:
- NGS can provide multiple quality-relevant insights within integrated workflows
- Scalable NGS adoption depends on making analysis accessible beyond bioinformatics specialists
- Trusted GMP assays require scientific understanding as well as compliance
- NGS infrastructure needs to accommodate evolving science, technologies, and regulatory requirements
1. One NGS Workflow, Multiple Quality Attributes
The value of NGS for product characterization extends beyond generating more sequence data. A single analytical approach can provide insight into multiple critical quality attributes, creating a more comprehensive picture of product identity, integrity, and safety.
Andrew Hillhouse of FUJIFILM Biotechnologies showed how modular NGS workflows can support product characterization for cell and gene therapies, including assessments of product integrity, genome integrity, and adventitious agents. Genedata Selector Playbooks support the analysis and interpretation of these complex datasets within integrated characterization workflows. This illustrates the potential of NGS toserve as not simply another analytical assay, but as a flexible framework for extracting decision-relevant insights from genomic data.
2. Bringing NGS Analysis Closer to the Scientist
As NGS expands into more development workflows, access to analysis becomes just as important as access to sequencing. The Rethinking Analytical Development with NGS roundtable reinforced this challenge, with participants discussing barriers to wider adoption and ways to make advanced genomic analysis more accessible beyond bioinformatics specialists.
Chaojie Wang, Senior Scientist at BMS, showed how Genedata Selector Playbooks can automate complex sequence variant analysis and make these workflows accessible to non-specialist scientists, reducing bottlenecks and freeing scientists and bioinformaticians to focus on higher-value activities. The Accelerating Cell Line Development Success with NGS roundtable extended the discussion, with participants discussing broader NGS adoption and opportunities for genomic data-driven decision-making across cell line development.
3. From NGS Method to Trusted GMP Assay
One message came through clearly: bringing NGS into a GMP environment is about more than compliance. A trusted assay also needs a strong scientific foundation, reproducible execution, and traceability. Giuseppe Semplicio, GMP Project Manager at Genedata, emphasized that this journey starts well before formal validation, with assay qualification establishing whether a method can reliably answer its intended biological question.
Kraig Theriault of AIRM brought this journey to life with a real-world example. AIRM has established a validated NGS framework supporting multiple GMP assays for cell and gene therapy safety testing and has engaged regulatory authorities on its approach, including through a Type D meeting with the FDA. Built on standardized analytical workflows and validated infrastructure, this approach can extend beyond a single assay. The Future-Proofing GMP with NGS roundtable took this idea further, exploring how reusable validation frameworks and the separation of platform from assay-specific workflow validation can support the introduction of new assays without repeatedly starting from scratch.
4. Building NGS Workflows That Can Evolve
NGS technologies, assays, and regulatory expectations will continue to change. The challenge is therefore not only to build workflows that meet today’s requirements, but to create an analytical foundation that can adapt as new applications and technologies emerge.
Ben Adamczyk, Product Manager at Genedata, showed how Genedata Selector is evolving to support NGS workflows from R&D through GxP. Genedata Selector Playbooks separate assay-specific logic from the core platform, while new capabilities across GxP, automation, data visualization, Apps, and AI support evolving sequencing-based workflows. Emerging AI capabilities prompted several questions during the Q&A.Looking ahead, the panel considered how automation, AI, and connected digital quality ecosystems can expand the role of NGS while maintaining the scientific judgment, governance, and traceability required for trusted decisions.
Beyond the Presentations: Peer Exchange in Practice
Some of the most valuable exchanges happened beyond the formal presentations. Three parallel roundtables gave participants space to compare experiences around future-proofing GMP with NGS, rethinking analytical development, and accelerating NGS-based cell line development. A panel with speakers from Astellas, BMS, FUJIFILM, and Genedata broadened the discussion, while posters, tailored demos, 1:1 project meetings, and networking provided further opportunities to explore specific workflows and implementation challenges.
Posters and Demos
AAV Manufacturing & Cell Line Characterization
NGS-MAM for Vector Characterization
GMP-Ready In-House NGS Analytics
AI-Ready NGS for CQA Assessment Across Development
Tailored demo sessions offered a closer look at comprehensive NGS-based adventitious agent detection and NGS-based product identity and integrity testing.
Interested in exploring these workflows in more detail? Request a demo to see how Genedata Selector can support your NGS initiatives.
Building the Future of NGS Together
Across the Open Forum, one message was consistent: advancing NGS in biopharmadepends on combining scientific rigor with approaches that are scalable, reproducible, and practical to implement.As NGS takes on a broader role across development and manufacturing, continued exchange between scientists and industry experts will be essential to turning emerging possibilities into approaches that work in practice.