The Biopharma Day, part of the Nanopore Community Meeting 2024 in Boston, included a session on “Implementation of sequencing in a regulated environment.” David VanHoute is from Regeneron Pharmaceuticals. VanHoute is in the manufacturing site of Regeneron and working on validating and implementing NGS assays. They are “in the business of hunting for viruses” and improving cell and gene therapies. Sebastian B. Teitz from very Teitz Consulting in Germany wore a PDA hat. PDA is a volunteer and member association focusing on adventitious virus detection, for example. The PDA also offers workshops and technical documents. They also publish peer-reviewed publications that inform the industry. Teitz spoke about guidance that was adopted to detect virus contamination with NGS. Gaston Vondenhoff from Lonza in The Netherlands spoke about the implementation of NGS for testing. Teitz noted that companies were reluctant to implement newer methods to replace PCR-based approaches. VanHoute spoke about incorporating multiple tests into one and how the Nanopore approach has been reliable for AAV quality control. They noted that regulation has changed. Vondenhoff explained that the analytical measurement of mRNA with direct RNA sequencing has helped to streamline the approach. Vondenhoff also mentioned that they are working with Nanopore to develop a process for facilitating the assessment of poly(A) tail length, capping, and mRNA integrity. Vondenhoff spoke about having “in-house” expertise in NGS that they leveraged. VanHoute said they were an early adopter of Nanopore since 2015. They started with the MinION and now have the Q line. Vondenhoff spoke about validating methods in one or two years to offer methods as a platform validated by q/c. The goal is to validate the platform for three products and offer it to customers.
