Biopharma QC in action: one platform, multiple quality attributes

Biopharmaceutical development relies on accurately characterising complex products. Researchers and manufacturers need to understand the identity, integrity, purity, and performance of the molecules they create, ensuring products are correctly assembled, free from contaminants, and functioning as intended. Traditionally, gaining these insights requires multiple analytical methods, which may increase workflow complexity and hands-on time throughout development and manufacturing.

Oxford Nanopore sequencing offers a different approach. By generating comprehensive sequence information from native DNA and RNA molecules, researchers and manufacturers can assess multiple critical quality attributes within a single workflow.

In this Tech Talk with Researchers blog, we hear from scientists exploring how nanopore sequencing can support biopharmaceutical quality control (QC). Their work demonstrates how Oxford Nanopore technology can help developers better understand the molecules they are designing, engineering, producing, and ultimately manufacturing. Along the way, we'll highlight additional resources that showcase what's possible with nanopore sequencing for biopharma applications. Plus, at the end, you'll find our suggested resources to help you get started.

From capsid candidate selection to vector QC

Stefan Hardy Lung (Institute of Virology Innsbruck, Austria)

Recombinant adeno-associated viruses (rAAVs) are among the leading delivery vehicles for gene therapies, so ensuring vector quality is critical.

At London Calling 2026, Stefan shared how he uses nanopore sequencing across the entire rAAV vector development workflow. By sequencing plasmids, capsid libraries, and final vectors, he can identify production issues, evaluate large libraries of engineered capsids, and assess vector quality.

Stefan also used direct RNA sequencing for transcript analysis following cell transduction, enabling him to examine transgene expression and splicing events. Together, his work demonstrates how nanopore sequencing can support end-to-end quality assessment throughout rAAV vector development and production.

Watch Stefan's short interview for a quick summary about his research or hear from the team at Addition Therapeutics to learn more about how nanopore sequencing is being applied to vector insertion site analysis and cell line characterisation. You can also read our blog on why the FDA recommends long-read sequencing for insertion site analysis and complex editing events detection.

Simplifying QC for mRNA therapeutics

Amanda Hughes (Lonza, The Netherlands)

The safety and efficacy of mRNA therapeutics depend on careful measurement of critical quality attributes such as identity, integrity, and purity.

Amanda presented Lonza's work on bringing nanopore sequencing into a current good manufacturing practice (cGMP) environment. Their aim is to develop a single assay that assesses multiple quality attributes, simplifying and accelerating QC testing of mRNA therapeutics.

A key focus of the Lonza team’s work has been demonstrating the accuracy and reproducibility required for regulated testing. By using consensus quality scoring, they showed performance comparable to established methods, such as Sanger sequencing, while maintaining highly consistent results across operators, GridION Q devices, and sequencing runs.

Hear more from Amanda in this short interview or discover how high-resolution sequencing is helping researchers de-risk RNA therapeutic development in this webinar with Eclipsebio.

Building a roadmap for biologics QC

Steven Verbruggen (OHMX.bio, Belgium)

As advanced therapeutics continue to diversify, researchers need streamlined QC strategies that can support multiple biologics and therapeutic modalities, from mRNA vaccines to genetically engineered cell lines and viral vectors.

Steven shared how OHMX.bio is developing a long-term roadmap to translate nanopore sequencing from research applications into GMP-grade biologics QC workflows. Building on the sequencing data the team already generates on GridION devices, they are working towards implementing GridION Q to enable the same information-rich analyses within GMP environments.

For more about the future of advanced therapy development, watch our London Calling 2026 studio discussion featuring experts from across the field.

Finding the right resources

If these examples have inspired you to explore nanopore sequencing for your own biopharma QC workflows, we have a range of resources to help you get started.

If you are new to Oxford Nanopore technology, explore our introductory guide, which highlights how nanopore sequencing can support researchers across therapeutic development, from early discovery through to quality assessment.

If you're ready to dive deeper, our getting started guide provides an overview of nanopore solutions and workflows across the biopharma pipeline, helping you identify the approaches best suited to your research and development goals.

Plus, our workflow overviews provide practical guidance across a range of applications, including AAV vector characterisation, plasmid construct verification, and amplicon sequencing for candidate screening. Researchers working in biomarker discovery can also learn more through our human variant calling workflow overview.

Finally, if you're looking to bring nanopore sequencing into applied and regulated environments, discover how GridION Q delivers all the benefits of multidimensional Oxford Nanopore sequencing alongside features designed to support quality-controlled workflows.

If you’ve enjoyed this Tech Talk with Researchers blog, why not try our Real Talk with Researchers series, where we hear from our community on topics such as accuracy, scalability, and the robustness of nanopore data.

Oxford Nanopore Technologies products are not intended for use for health assessment or to diagnose, treat, mitigate, cure, or prevent any disease or condition.