This certification enhances QuTEM’s credibility and reliability with clients and regulatory bodies, reinforcing their trust in QuTEM’s bioanalytical services, especially in Transmission Electron Microscopy (TEM). As the sole GMP-certified provider of electron microscopy services, QuTEM is uniquely positioned to support the biopharmaceutical industry with accurate and reliable data essential for product development. This certification allows QuTEM to perform quality control analyses that align with global regulatory standards, streamlining the approval and market entry of new biopharmaceutical products across various markets.

Dr. Josefina Nilsson, CEO of QuTEM, remarked on the achievement, “Since our predecessor Vironova BioAnalytics became the world’s first and only GMP-certified electron microscopy laboratory in 2020, we have continuously provided top-tier TEM services. Maintaining our GMP certification demonstrates our commitment to quality and innovation, ensuring that our clients receive the most reliable data possible.”

Pioneering Quality and Innovation

QuTEM is recognized globally as a leader in GMP-certified TEM services and nanoparticle quality control for the life sciences industry. With a team of 27 experts in fields such as structural biology, nanotechnology, and virology, QuTEM delivers comprehensive support across the entire value chain, from research to commercial applications. Their services, often delivered within 4-10 business days, are essential in time-sensitive biopharmaceutical vector manufacturing.

Using its proprietary software, Gridsee, which employs advanced AI to classify nanoparticles, QuTEM transforms electron microscopy images into actionable data, a critical step in improving pharmaceutical safety and efficacy. This GMP-compliant software is continuously updated to meet the industry’s evolving demands, keeping QuTEM at the forefront of bioanalytical technology.

A significant area of focus for QuTEM is gene therapy, particularly with adeno-associated virus (AAV) vectors, which have revolutionized treatments for chronic genetic conditions like vision and hearing disorders and hemophilia. QuTEM’s patented method for determining genome length in AAV vectors is both validated and GMP-compliant, offering unparalleled accuracy and efficiency. This method can significantly reduce the time and costs associated with bringing new gene therapy products to market.

QuTEM is also advancing the analysis of lipid nanoparticles and lentiviral vectors, key components in modern vaccines and gene therapies. By automating image analysis and release processes, QuTEM is increasing its capacity to meet the growing demand for these crucial services.

“Our third-generation AAV analysis method has exceeded our expectations in accuracy and sensitivity. This GMP-compliant method significantly accelerates the development of new gene therapies,” added Dr. Nilsson. “As demand for our services grows, automation will be essential in maintaining our high standards while scaling operations.”

Building Trust in Tomorrow’s Therapies

QuTEM’s GMP certification and dedication to innovation are central to building trust in tomorrow’s therapies. By making the invisible visible, QuTEM ensures that the therapies of the future are developed with the highest quality and safety standards. As QuTEM continues to innovate and refine its analytical methods, it remains a leader in bioanalytics, contributing to global patient safety and advancing the biopharmaceutical industry.

Katalysen Ventures is proud to support QuTEM as it continues to set industry benchmarks, helping to deliver safe and effective therapies to patients around the world.