CryoTEM is an advanced form of electron microscopy where samples are rapidly frozen and imaged at extremely low temperatures. This makes it possible to study viruses, nanoparticles, lipid nanoparticles, and other nanoscale biological samples in a near-native state and at very high resolution. The technology is increasingly relevant within areas such as gene therapy, nanomedicine, biologics, and advanced nanoparticle-based therapeutics, where nanoscale structure itself can influence product quality, safety, and efficacy.

The updated USP certificates now include CryoTEM as a powerful addition to the existing orthogonal analytical techniques used to characterize adeno-associated virus ("AAV") vectors, one of the leading delivery platforms used in gene therapy. According to QuTEM, CryoTEM is the only method included that directly visualizes individual particles, enabling classification of full, intermediate, empty, and overfull capsids based on internal density rather than relying solely on indirect biophysical signals.

"As a pioneer of quantitative CryoTEM for biopharmaceutical applications, QuTEM is proud to see this technology recognized by the US Pharmacopeia," said Josefina Nilsson, CEO at QuTEM. "CryoTEM is now ready for routine QC use and release testing, with automated workflows and a validated platform that classify every capsid as full, intermediate, empty, or overfull at a level of detail that indirect biophysical methods simply cannot match. Along with the recognition by the British Pharmacopoeia, USP's decision demonstrates that CryoTEM is being accepted as a valuable part of the AAV analytics toolbox - and it has a lot to offer, because it delivers particle-level resolution of a significant CQA while supporting consistent and reliable analytics at QC scale."

Christian Holmer, Advisor to Katalysen Ventures, also commented on the news: "The inclusion of CryoTEM in USP's AAV reference standard certificates is a significant milestone for QuTEM, and also signals recognition of CryoTEM as an important analytical method across the gene therapy sector more broadly. For QuTEM's customers, including biopharmaceutical companies developing AAV-based gene therapies, this recognition has practical value: it strengthens the case for using CryoTEM as part of their analytical toolkit and provides a stronger foundation when demonstrating to regulators that their vectors meet relevant quality and fill-level specifications. As an investor in QuTEM, we see this as meaningful validation of both the technology and QuTEM's years of work building GMP-ready, validated infrastructure around it, positioning the company well as industry adoption of CryoTEM in routine quality control continues to develop."

For more information, see the full press release from QuTEM.