OHMX.bio offers a full range of quality control solutions for cell line, viral vector, plasmid and/or mRNA characterisation. Biologics are nowadays often the result of gene editing, transfections, or other advanced biotechnological methods. As these biologics are administered directly to patients, e.g. through advanced cell & gene therapies, quality control (QC) is one of the, if not the, most important aspect in the development process and manufacturing of these biologics. However, the methods used for QC are often dated and cannot be considered precise, focusing more on consequences than causes, using patient monitoring and flow cytometry. Sequencing, and more specifically long-read sequencing, offers a precise solution. By sequencing edited or transfected cells, the actual genetic code can be monitored for variants or indels (genetic stability), copying, frameshifts, or other unwanted changes (structural variations), as already suggested in the most recent ICHQ5A(R2) guidelines.
Click here to read our White Paper for more information about our QC Biologics activities.