Advancing Biopharma quality control: Oxford Nanopore Technologies at NCM Boston 2024

By Veronica Fowler, Director, Commercial Development (Applied Markets), Oxford Nanopore Technologies, and Chris Brown, VP Strategic Programmes, Oxford Nanopore Technologies

As the biopharma industry continues to rapidly evolve with cutting-edge therapies and evolving regulatory expectations, the demand for innovative solutions has never been greater. At today’s Biopharma Day at NCM Boston 2024, Oxford Nanopore’s customers highlighted how the platform is shaping the future of a rapidly evolving sector.

Overcoming the QC challenge in biomanufacturing

Current QC testing in biopharma is complex and time consuming, meaning costs are high and efficiencies are low. The industry requires faster, more streamlined QC solutions that not only meet regulatory standards but also keep pace with modern therapy development.

Regulatory and market shifts

Regulatory demands and the rise of next-generation therapies, including mRNA-based treatments, has required regulatory bodies to adapt to a new way of measuring critical quality attributes. As highlighted by Andreas Czech, Director of Analytical Development at BioNTech and reiterated by Gaston Vondenhoff, at Lonza, to stay competitive and compliant, biopharma companies must integrate cutting-edge technologies, such as nanopore sequencing, into their QC laboratories. This shift creates opportunities for streamlining operations while ensuring the quality and safety of biopharmaceuticals.

'Oxford Nanopore sequencing offers a plethora of advantages to the existing analytical methodologies in the field of mRNA therapeutics that include improvements in speed and the quality of results' , Vondenhoff said.

Colette Cote at PathoQuest, shared her insights on the considerations and steps required to take a Nanopore analytical method and turn it into a GMP validated method for – in in this case – integration site analysis.

'This is a platform that can easily be validated for GMP compliance', she said.

In the field of adventitious viral agent detection, Serge Monpoeho, Executive Director and Chief Virologist at Regeneron Pharmaceuticals, and Charles Swofford, Assistant Director of Biomanufacturing Initiatives at MIT’s Center for Biomedical, discussed the transformative impact of sequencing in a traditionally conservative sector.  This sentiment was further reinforced by Sebastian Teitz of veryTeitz Consulting, who shared updates from the recent PDA viral safety conference, highlighting that the time is now for broader sequencing adoption.

'Sequencing is pushing regulators to re-think what the requirements should actually be', Teitz said.

David VanHoute of Regeneron shifted the focus to cell and gene therapies, showcasing how nanopore sequencing can be leveraged to assess critical quality attributes of vectors used in the production of therapies like adeno-associated viral vectors.

'Nanopore sequencing provides consistent quality for AAV characterisation', VanHoute said, adding 'our goal is to convert our laboratory to a sequencing-based laboratory'

Oxford Nanopore's streamlined QC solution

Oxford Nanopore’s platform replaces multiple traditional QC tests with a single, efficient solution. Oxford Nanopore sequencing technology offers a fast, comprehensive approach to QC that is highly adaptable to the needs of the biopharma industry. From measuring mRNA, plasmid and AAV critical quality attributes, to detecting viral contaminants, our platform ensures precise and efficient QC processes.

Collaborating with industry leaders

Oxford Nanopore is proud to work alongside leading companies in the biopharma industry worldwide, including BioMérieux, Lonza, PathoQuest, and more. Our partnerships address specific QC challenges and help organisations leverage sequencing technology to boost efficiency, reduce production timelines, and ensure compliance with regulatory demands. Validated by industry leaders, our technology has already been adopted by major biopharma companies and is poised to support the rapidly growing biopharma sector going forward.

Daniel Fabian from Lonza said 'Nanopore genome sequencing enables precise assessment of genetic quality during process development saving time and reducing cost'.

Charting the future of Oxford Nanopore sequencing in biopharma

As biopharma continues to innovate, QC solutions must evolve accordingly. Rounding out the end of the day, it was inspiring to hear enthusiasm from industry leaders about the use of nanopore sequencing in other areas of QC testing, such as sterility, bacterial ID and typing and cell-line clone selection.

'Nanopore long read sequencing could provide in the future a rapid assessment of viral pathogens during cell biomanufacturing', said Stacy Springs from the MIT Center for Biomedical Innovation.

Oxford Nanopore Technologies is at the forefront of this transformation, providing the tools to address modern biomanufacturing challenges.