Biopharma
From discovery to clinical trials and manufacturing
High-quality multiomic sequencing data has become an integral part of the drug development process. From research identifying novel drug targets, lead candidates, and biomarkers, to routine quality control (QC) testing during the manufacturing of therapeutics such as cell, gene, and mRNA therapies, Oxford Nanopore offers a single-platform solution that can improve probability of success (PoS) and may reduce time to market.
Nanopore sequencing allows you to overcome the limitations of legacy short-read technologies, which require fragmentation and amplification of nucleic acids, by directly sequencing DNA or RNA fragments of any length quickly and efficiently — providing you with confidence and speed at every stage.
The ultra-rich, multiomic data generated by nanopore sequencing provides comprehensive insights into the molecular determinants of health and disease and greater understanding of mechanism of action (MoA).
Nanopore sequencing delivers:
- Ultra-rich data — for comprehensive insights
- Any read length — from short to ultra-long (>4 Mb)
- PCR-free data — no amplification bias
- Built-in methylation detection — no additional bisulfite or enzymatic conversion
- Real-time analysis — immediate access to actionable results
)
)
Find out more about solutions for cell and gene therapy
Next-generation sequencing (NGS) is now an essential tool across the drug development value chain; however, the requirement of legacy NGS technologies for nucleic acid fragmentation and amplification erases critical sample information. Nanopore sequencing from Oxford Nanopore overcomes these limitations to reveal the true biology of your samples.
Research and development (R&D) / early development
Oxford Nanopore offers industry-leading sequencing solutions across the whole spectrum of biopharmaceutical R&D — from initial target identification and biomarker discovery to cell line and viral vector engineering, all the way through to cell, gene, and RNA therapy drug development.
Nanopore sequencing uncovers what you have been missing with other conventional assays and legacy sequencing technologies. With high-accuracy, any-length reads, you can achieve comprehensive variant analysis, capturing single nucleotide polymorphisms (SNPs) and large, complex structural variants (SVs), to determine any off-target effects and reduce risk.
With simple, rapid, end-to-end workflows, you can easily perform:
- Whole-genome sequencing
- Bulk transcriptomics
- Single-cell and spatial transcriptomics
- Multiomics
- Tumour-normal sequencing
- Plasmid sequencing
- Direct RNA sequencing (e.g. messenger RNA [mRNA])
- Adeno-associated virus (AAV) sequencing
- Amplicon sequencing
- Nanopore-only microbial isolate sequencing (NO-MISS)
Analytical development / clinical trials
At Oxford Nanopore, we offer comprehensive support for customers transitioning from R&D methods to analytical development, and finally, to a good manufacturing practice (GMP)-validated QC assay. We can equip you with stage-appropriate devices, reagents, and thorough documentation — ensuring a smooth and efficient process throughout your clinical trials and manufacturing process.
Advancing to clinical phase is a significant milestone in the drug development pathway. Oxford Nanopore is here to support you so that you feel confident, well-prepared, and equipped to achieve success, whilst reducing risk.
If you would like to talk to a biopharma technical specialist on how nanopore sequencing can be used, please get in touch via email.
)
Find out how researchers are transforming the future of clinical genetic testing
Dr Ahmad Abou Tayoun is focused on improving diagnosis for patients with rare diseases in the Middle East. Find out how he has uncovered 13% more potential diagnoses, changing the face of clinical genetic testing.
)
Find out more about solutions for QC in biopharma
Throughout the drug development pathway, numerous analytical methods are used to measure CQAs of drugs. Nanopore sequencing enables single QC tests that can replace multiple legacy analytical assays.
Manufacturing / commercial and quality control (QC)
Oxford Nanopore is redefining the landscape of genetic analysis during biomanufacturing of therapies to meet the regulatory requirements for clinical trials and subsequent commercial products.
Historically, numerous analytical methods are necessary for routine QC testing of drugs produced within GMP environments. Nanopore sequencing enables comprehensive QC tests that can measure multiple CQAs with less complexity than conventional assays and legacy sequencing technologies — all in one assay and with faster results.
Oxford Nanopore QC Test Packs include the required consumables, analysis pipelines, and documentation to perform:
- Plasmid identity testing
- mRNA identity testing, including capability to analyse basic integrity and purity (poly-A tail length estimation) attributes
- Adventitious viral agents (AVA) testing (test pack in development)
- Insertion site analysis (ISA) testing (available as a Q-Line product — register your interest for Q-Line)
Test packs for other applications, including customisation options, are currently in development.
Additionally, Oxford Nanopore’s Q-Line products deliver all the benefits of nanopore sequencing in a locked-down, standardised format — ideally suited for use in regulated GMP environments.
Discover Q-Line
The GMP-ready sequencing solution. Q-Line products provide the critical infrastructure necessary to ensure the seamless and scalable transfer of nanopore-sequencing based analytical methods from discovery to commercialisation.
- Compatible with QC Test Packs
- Proven, locked-down technology
- Onboard sequencing software to support 21 CFR Part 11 and EU GMP Annex 11 requirements
- Comprehensive support packages
- Clearly defined, visible product update pathway and implementation support
- ISO 9001:2015 certified product manufacturing process
)
Our platform
A range of RUO sequencing devices and flow cells allows great flexibility to tailor your throughput and application needs more precisely.
)
MinION
The only portable, real-time devices for DNA and RNA sequencing, giving complete control and creativity over when, where, and how often you sequence, regardless of application.
)
GridION
Compact benchtop device designed to run and analyse up to five Flongle or MinION Flow Cells for simple and robust scalability.
)
PromethION
From the affordable, compact, and accessible PromethION 2 devices to the flexible, large-scale, high-output PromethION 24, access up to terabases of data, on demand.
)
