Biopharma
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Accelerate biopharmaceutical development with a single sequencing platform that replaces fragmented assays — delivering full-length, real-time multidimensional insights from discovery through to good manufacturing practice (GMP)-ready quality control (QC).
Oxford Nanopore sequencing is a single-platform solution for your entire pipeline, so you can simplify workflows, reduce risk, stay compliant with confidence, and make fast decisions. Reveal the full molecular picture of plasmid constructs, viral vectors, mRNA therapeutics, and more.
What sets Oxford Nanopore apart?
- Replace multiple assays with a single QC test
- Generate full-length sequence data in real time
- Verify construct and therapeutic identity, integrity, and purity with confidence
One solution — from R&D to QC
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Accuracy you can trust — insight you can act on
Cell and gene therapy development is inherently complex. Discover how comprehensive nanopore sequencing acts as a critical checkpoint at every stage, providing you with the data you need to develop better and safer drugs.
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Compliance built in. Confidence delivered.
Learn how the Oxford Nanopore QC Test Packs for plasmid and mRNA critical quality attribute (CQA) testing provide everything you need to successfully deploy in GMP environments.
'Nanopore sequencing enabled our scalable, end-to-end quality control pipeline throughout the whole production of our recombinant AAV vectors'
Stefan Hardy Lung
Institute of Virology Innsbruck, Austria
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Q-Line: sequencing in regulated environments
Q-Line is a range of sequencing products designed to support regulated GMP environments. It delivers real-time nanopore sequencing in a standardised, tightly controlled format, supporting seamless and scalable transfer of analytical methods from discovery to commercialisation.
Discover the Q-Line GridION
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Five MinION Flow Cells can be operated individually or together
Industry-specific software supporting 21 CFR Part 11 and EU GMP Annex 11 configuration
Onboard data analysis
Pre-configure run settings for specific QC assays
What's the difference between GridION and Q-Line GridION?
GridION
- Ideal for R&D and discovery workflows
- Rapid access to updated versions and new features
- Conduct multiple experiments on a single device
- Low validation burden — plug in and begin experiments
Q-Line GridION
- Ideal for analytical development and GMP workflows
- Change-controlled configuration lifecycle
- Qualification packages available (IQ, OQ, and IPV)
- Long-term configuration support
What are the key challenges in biopharma development workflows?
Biopharma development workflows are often complex, slow, and fragmented, relying on multiple specialised assays for product identify confirmation, safety assessment, and integrity checks. These disconnected steps increase costs, slow decision-making, and make it harder to maintain consistency across discovery, scale-up, and GMP environments. Many companies are seeking new strategies to streamline these processes without compromising data quality.
How can nanopore sequencing accelerate biopharma development and quality control?
Oxford Nanopore sequencing brings together what were previously separate steps into a single workflow. By delivering real-time, any-length reads and multiomic insights on a single platform, it reduces reliance on fragmented legacy assays across discovery/R&D, analytical development, and GMP-ready QC. With scalable sequencing devices that are easy to implement into existing workflows, labs can move faster, make informed decisions earlier, and maintain compliance with emerging regulatory expectations.
What are the limitations of traditional sequencing methods in biopharma development?
Legacy sequencing approaches — such as Sanger and short-read next-generation sequencing (NGS) — have played an important role in establishing sequencing in biopharma workflows. However, these approaches fragment DNA and rely on amplification, which can obscure structural variants, repetitive sequences, and epigenetic modifications. These methods deliver partial insights and struggle to fully characterize molecules like plasmids, viral vectors, or RNA therapeutics. As a result, multiple workflows are often needed, adding time and cost without removing the underlying blind spots that matter for regulatory confidence.
