Lonza, Oxford Nanopore launch direct RNA sequencing platform for GMP quality control

Lonza, a contract development and manufacturing organization (CDMO) headquartered in Basel, Switzerland, and Oxford Nanopore Technologies, a molecular sensing technology company based in Oxford, UK, have launched a direct RNA sequencing solution designed to modernize Good Manufacturing Practices (GMP) quality control testing for mRNA therapeutics.

The approach combines Oxford Nanopore's direct RNA sequencing technology with machine learning-based data analysis and customized software to enable multiple critical quality attributes to be assessed within a single workflow. Current mRNA quality control testing often relies on complex, single-attribute assays across multiple analytical platforms with long turnaround times, the companies said. The new platform is reportedly designed to consolidate those readouts into a single system, with automated data analysis and reporting intended to support decision-making across the product lifecycle.

Oxford Nanopore's direct RNA sequencing enables native sequencing of full-length mRNA molecules without amplification, and when combined with machine learning, analyzes large numbers of individual RNA strands to generate consensus data, according to the announcement. The method is sequence-agnostic and designed as a scalable, platform-based solution across mRNA products, the company said.

Sönke Stocker, executive director of R&D mRNA and external innovation for specialized modalities at Lonza, said in a statement the technology introduces a “simplified, multi-attribute approach that better aligns GMP quality control with the pace and complexity of modern mRNA development while maintaining the rigor required for regulated manufacturing.”

Francis Van Parys, CEO of Oxford Nanopore Technologies, said in a statement the “collaboration demonstrates how multi-attribute sequencing can simplify quality control and support more efficient biopharmaceutical manufacturing.”

The launch follows other recent platform introductions at Lonza. Last week, the company launched an adeno-associated virus (AAV) stable producer cell line platform designed to reduce variability and cost associated with transient transfection-based AAV manufacturing.