Stockholm-based QuTEM has reached an important milestone in its mission to improve the quality and safety of next-generation medicines. A new peer-reviewed study, published in Molecular Therapy: Methods & Clinical Development, demonstrates QuTEM’s innovative electron microscopy technology and image analysis as a reliable and precise standard for analyzing the building blocks of gene therapy.

This breakthrough originates from QuTEM’s technology. In collaboration with Viralgen SL, a leader in the manufacturing of gene therapy vectors, Viralgen applied complementary analytical methods that further confirmed QuTEM’s breakthrough. The study showed that QuTEM’s method is more reliable than several established techniques, underscoring its potential as a new benchmark for quality control in gene therapy.

Why this matters

“QuTEM is a real success story in our portfolio," comments Peter Almberg, Chairman of Katalysen. "We have observed how QuTEM has evolved from an imaging company to, today, being an analytics company with its own proprietary software developed inhouse, Gridsee, and immense amounts of unique data collected over 15+ years. As investors, we see that from such a position QuTEM is uniquely placed to extract increasing value from its analytical capabilities and insights. An undeniable prerequisite is first to achieve gold-standard status in the industry."

“This recognition confirms QuTEM’s role as a potential golden standard for quality control in gene therapy,” said Josefina Nilsson, CEO of QuTEM. “The fact that Viralgen, a leader in AAV manufacturing, together with other major pharmaceutical companies, have decided to outsource an essential part of their quality control to us demonstrates that QuTEM’s innovative approach is already embraced by the industry’s most respected players.”

For investors, this milestone highlights QuTEM’s growing relevance in a rapidly expanding global market. The gene therapy sector is forecast to see strong growth in the coming decade, and demand for reliable quality control tools is set to rise sharply. With confirmation from both the scientific community and leading players in gene therapy manufacturing, QuTEM is well positioned to play a central role in ensuring the safety, consistency, and success of future therapies.

"QuTEM's long-term trajectory is extremely exciting for investors," concludes Peter Almberg. "It is one of our core investments, and our holding is approximately 15% of the company. The fact that the company is now profitable, while at the same time adding a new sales model that significantly increases global scalability, makes QuTEM’s outlook all the more compelling.”

Analyzing the building blocks of gene therapy

Gene therapy is one of the most exciting frontiers in medicine, with the potential to cure diseases previously thought untreatable. At the heart of these therapies are tiny carriers called AAV (adeno-associated viruses) vectors, which are engineered viruses commonly used to deliver therapeutic genes into patients’ cells. But not all these carriers are created equal. Many are either empty or only partially filled, which can reduce therapeutic efficacy and may also increase the risk of an immune response.

Until now, accurately measuring and controlling this quality issue has been a challenge for the pharmaceutical industry. The newly published study shows that QuTEM’s method offers a more precise and detailed way to distinguish between full, partial, and empty AAV particles. Compared with other techniques, including analytical ultracentrifugation (AUC), mass photometry (MP), and SEC-HPLC, QuTEM stood out for its ability to directly visualize each viral particle in its native state, while still producing results consistent with recognized benchmarks.

QuTEM’s method has been designed and developed in accordance with international quality guidelines ICH Q2 (R2), which define standards for the validation of analytical methods, and operates under a Good Manufacturing Practice (GMP) certificate from the Swedish Medical Products Agency. Today, QuTEM’s approach is already integrated as an important quality control measurement and release test for gene therapy products, supporting both biotech innovators and large pharmaceutical companies as they scale up life-changing therapies.