Scaling viral vector manufacturing: connecting upstream feed to downstream recovery

Dr Stefano Menegatti is a Professor and University Faculty Scholar in the Department of Chemical and Biomolecular Engineering at North Carolina State University and Chief Scientific Officer at ChromaGenix. A recognized leader in bioseparations and biomanufacturing, his research focuses on advanced purification processes and analytical technologies for biological therapeutics, including proteins, viral vectors, and cells. 

He is also a co-founder of the North Carolina Viral Vector Initiative in Research and Learning (NC-VVIRAL). His contributions to biomanufacturing have been recognized with honors including the NSF CAREER Award, ALCOA Foundation Research Achievement Award, Goodnight Early Career Innovator Award, and 2025 ACS BIOT Young Investigator Award. Dr Menegatti holds a PhD in Chemical Engineering from NC State and BSc and MSc degrees in Chemical Engineering from the University of Bologna.

Romas Skudas is an R&D Director in Life Science, specializing in chromatography and downstream bioprocessing technologies for the purification of biologics. Based in Darmstadt, Germany, he leads research and innovation activities focused on next-generation chromatography media, affinity ligands, membrane technologies, and advanced purification solutions for antibodies, viral vectors, and other emerging therapeutic modalities. 

Throughout his career, Romas has combined scientific expertise with a strong focus on translating innovation into commercially relevant products. He has led multidisciplinary and international teams working across protein engineering, polymer and surface chemistry, analytical development, and bioprocess applications. His recent work includes the development of novel affinity chromatography platforms for adeno-associated viruses, next-generation Protein A and Protein L technologies, and the integration of newly acquired chromatography technologies into a broader innovation portfolio. 

Romas is particularly passionate about accelerating innovation through close collaboration between R&D, customers, academic partners, and external technology companies. He advocates rapid experimentation, early customer validation, and strong scientific ownership within project teams. 

His long-term professional focus is the development of high-capacity, highly stable, sustainable purification platforms that enable more efficient and economical manufacturing of advanced biopharmaceuticals. 

Thomas Villiger is Professor of Bioprocess Technology at the University of Applied Sciences and Arts Northwestern Switzerland (FHNW). He completed his Master's and PhD degrees at the Institute for Chemical and Bioengineering at ETH Zurich. Prior to returning to academia, he spent more than a decade in the biopharmaceutical industry, working in development and manufacturing roles at several large pharmaceutical companies. 

His current research focuses on new modalities such as AAV-based gene therapies, applying engineering and model-based approaches to accelerate the development of next-generation biotherapeutics. The focus of his research group is product quality and control strategies, continuous and intensified bioprocessing, and process analytical technology (PAT), bridging the gap between advanced manufacturing concepts and robust, quality-driven implementation throughout the product lifecycle.

Eric Hacherl, PhD, is Managing Partner at SMART Bio Works, a consultancy established in 2020 to bring commercialization expertise and workforce development solutions to the Life Sciences industry. Eric is co-lead of the NIIMBL Viral Vector Program Team, focused on developing an open-source process and analytical platform for gene therapy manufacturing. He is also COO of Kyttaro Therapeutics, an advanced therapy start-up producing groundbreaking work using genetically modified mesenchymal stem cell lines for therapeutic treatments.

Formerly, he was Vice President and Head of Manufacturing at Spark Therapeutics, headquartered in Philadelphia, Pennsylvania. In this role, he oversaw internal and external manufacturing, materials management, and manufacturing science & technology (MS&T).

Before joining Spark, Eric was Site General Manager and VP of Operations for Catalent Gene Therapy in Baltimore, MD. Earlier in his career, he served in increasingly responsible operations and technical roles during his 15 years with Merck & Co.

With 25 years’ experience in the pharmaceutical industry, Eric’s subject matter expertise includes operations, supply chain, and MS&T in large-molecule and vaccines, as well as cell and gene therapy.

He holds a PhD in Chemical Engineering from Rutgers University, funded by an NIH Biotechnology Training Fellowship and the U.S. Department of Energy.

Alexandra Bogdanovic is a Research Scientist at APC Ltd in Dublin, Ireland. She holds a BSc in Industrial Biochemistry from the University of Limerick and a PhD in Chemical and Bioprocess Engineering from University College Dublin. Alexandra joined APC Ltd in 2020 as a Bioprocess Development Scientist and has since worked across a range of modalities, with experience spanning both upstream and downstream process development.

Her current research at APC Ltd is part of the Innovation team, where she focuses on advancing research and innovation in recombinant adeno-associated virus (rAAV)-based gene therapies. The Innovation team at APC Ltd takes a holistic approach to the development of the rAAV manufacturing process, spanning plasmid design and production, cell line selection, transfection optimisation, and downstream purification.

Her primary research focus is the development of a serotype-agnostic platform for the production and purification of rAAV therapies. The platform aims to increase rAAV yields and quality, streamline experimentation, and reduce manufacturing costs, helping to make these medicines more accessible to patients while incorporating manufacturability considerations from the earliest stages of development.