Research Areas

Dr. Štrancar's research spans several interconnected fields at the intersection of polymer science, chromatography, and biopharmaceutical manufacturing. His pioneering work on CIM (Convective Interaction Media) monolithic chromatography has opened new frontiers in the purification of large biological molecules, gene therapy vectors, and vaccines. Below are the key areas of his ongoing scientific contributions.

Dr. Aleš Štrancar with CIM monolithic chromatography columns at BIA Separations

Dr. Štrancar with CIM monolithic chromatography columns at BIA Separations

CIM Monolithic Chromatography

Convective Interaction Media (CIM) monolithic chromatography represents a paradigm shift in liquid chromatography. Unlike conventional particle-packed columns, CIM monoliths consist of a single piece of highly porous polymer with interconnected channels that enable convective mass transport. This eliminates the diffusion limitations inherent in particle-based systems, allowing flow-independent resolution and dramatically faster separations of large biomolecules. Dr. Štrancar pioneered the development of methacrylate-based CIM monolithic columns, which have become the gold standard for the chromatographic separation and purification of viruses, viral vectors, plasmid DNA, and other large biological molecules.

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Gene Therapy Manufacturing

Gene therapy represents one of the most promising frontiers in modern medicine, offering the potential to cure genetic diseases at their root cause. Dr. Štrancar's CIM monolithic chromatography technology has become an essential tool in the manufacturing of gene therapy products, particularly adeno-associated virus (AAV) vectors. BIA Separations' CIM columns played a critical role in the manufacturing of Zolgensma (onasemnogene abeparvovec), a groundbreaking AAV9-based gene therapy for spinal muscular atrophy developed by AveXis (now Novartis Gene Therapies). The technology enables efficient, scalable purification of viral vectors, including the critical separation of empty and full AAV capsids.

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Bioprocess Analytics

Bioprocess analytics encompasses the analytical tools and methods used to monitor, control, and optimize biopharmaceutical manufacturing processes. Dr. Štrancar has made significant contributions to this field through the development of CIM monolithic analytical columns that enable rapid in-process monitoring of biopharmaceutical production. These fast analytical methods allow real-time assessment of product quality, impurity levels, and process consistency, supporting the implementation of Process Analytical Technology (PAT) and Quality by Design (QbD) approaches in biomanufacturing. The miniaturized CIM disk format is particularly valuable for high-throughput process development and screening applications.

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Virus & VLP Purification

The purification of viruses and virus-like particles (VLPs) is critical for vaccine production, gene therapy, and biomedical research. Conventional chromatographic columns with small pore sizes restrict access of large virus particles to binding sites, resulting in low capacity and poor separation. CIM monolithic columns, with their large interconnected pore channels, allow unrestricted access of virus particles (typically 20-300 nm in diameter) to the entire stationary phase, achieving high dynamic binding capacity and excellent recovery of intact virus particles. Dr. Štrancar's research has demonstrated the successful purification of numerous virus types including adenovirus, adeno-associated virus, influenza virus, hepatitis B VLPs, and bacteriophages using CIM technology.

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Polymer Monolith Science

The science of polymer monoliths forms the fundamental basis of CIM technology. Dr. Štrancar's research has advanced the understanding of monolith formation through free-radical polymerization of methacrylate monomers, particularly glycidyl methacrylate (GMA) and ethylene dimethacrylate (EDMA). His work has elucidated the relationships between polymerization conditions (temperature, initiator concentration, porogenic solvents) and the resulting pore structure, surface area, and chromatographic performance of the monolithic material. This fundamental understanding has enabled the design of monoliths with tailored properties for specific applications, from analytical miniaturized disks to large-scale industrial columns with volumes exceeding 8 liters.

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Animal-Free Toxicity Testing

Co-founded Infinite Biotech to develop animal-free alternatives for toxicity testing, aiming to reduce reliance on animal models in pharmaceutical development. This initiative addresses one of the most pressing ethical and scientific challenges in drug development by leveraging advanced in vitro methodologies and analytical techniques to provide more predictive, humane, and cost-effective safety assessments for new therapeutics.

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