Investment company Katalysen says that portfolio company QuTEM, in which the investment company owns 15 percent via Venture Targeter, has had the analysis method CryoTEM included in updated certificates for the US USP reference standards for AAV8 vectors in gene therapy.According to QuTEM, CryoTEM is the only method in the certificates that directly visualizes individual virus particles and enables classification of capsids as full, empty or overfilled based on internal density.QuTEM develops quantitative CryoTEM for biopharmaceutical applications and has built validated workflows and software for quality control. The company describes the inclusion as an important step toward establishing the technology within routine quality control and regulatory processes."As a pioneer in quantitative CryoTEM for biopharmaceutical applications, QuTEM is proud to see the technology recognized by US Pharmacopeia", says Josefina Nilsson, CEO of QuTEM."CryoTEM is now ready for routine quality control and release testing, with automated workflows and a validated platform that classifies each capsid as full, intermediate, empty or overfull at a level of detail that indirect biophysical methods simply cannot match. Together with the recognition from British Pharmacopoeia, USP's decision shows that CryoTEM is accepted as a valuable part of the toolkit for AAV analysis – and the technology has much to offer because it provides particle resolution for a significant critical quality attribute while enabling consistent and reliable analysis at quality-control scale", she continues.