AAV downstream challenges: expert insights

A biochemist by education, Nicolas Laroudie worked at Généthon, France between 2001 and 2011 as Head of Downstream Development. He led a team developing and scaling up purification processes for AAV, retroviral, and lentiviral vectors used for gene therapy treatments. He then joined Merck Millipore as a BioManufacturing Engineer and supported European customers for all downstream process (DSP) technologies with a strong focus on chromatography. In particular, he took an active role in the establishment of a fully continuous, large-scale disposable DSP process for the purification of a monoclonal antibody, within the framework of a large multi-company European consortium. Next, he joined Thermo Fisher Scientific in 2019 as a Field Application Specialist for purification, supporting the technical implementation of POROS and CaptureSelect chromatography products in southwestern Europe.

Dr. Clément has 25+ years of experience in the field of Gene Therapy, with industry leading expertise in adeno-associated virus (AAV) viral vectors manufacturing. At the Powell Gene Therapy Center of the University of Florida, Gainesville, she led AAV process development and manufacturing for R&D POC, IND-enabling Toxicology and IND studies. During this time, she oversaw the manufacturing, release testing and stability campaigns for more than eight AAV INDs, including QC assay qualifications and CMC preparations. Her lab’s research focused on developing scalable GMP-ready platforms using the HSV and the transfection systems in suspension. Dr. Clément joined the large CDMO Resilience, as the Director of the Process Development for Viral Vaccines and Gene Therapy, where she oversaw multiple industry-sponsored manufacturing programs, at scale up to 200L in suspension and adherent bioreactor formats. Since January 2022, Dr. Clément holds the role of Vice President of Vector Development for Translational Gene Therapies at Siren Biotechnology LLC, San Francisco, a startup focused on delivering a cure to cancer using AAV mediated gene transfer. At Siren, she leads CMC operations to bring Siren’s clinical candidates to the patients.

Matt is the Director of AAV Production at BridgeBio, where he is focused on designing and implementing new strategies for the production and purification of adeno-associated virus. Matt completed his Bachelor’s degree in Biological Sciences at North Carolina State University and his Master’s degree in Microbiology and Cell Science at the University of Florida. Prior to BridgeBio, Matt spent time at Precision BioSciences leading the AAV Process Development group, Pfizer working on the purification of AAV, and the Biomanufacturing Training and Education Center training industry professionals on downstream bioprocessing operations.

William Kish is a purification scientist with over a decade of experience across industry and academia. As a Principal Scientist at Taysha Gene Therapies, he leads Taysha’s downstream CMC activities, including process development, characterization, tech transfer, CDMO oversite, and authoring of regulatory documents. Previously, William worked at Pfizer to develop purification processes for mAb, AAV9 and AAV3b assets. His most impactful contributions focus on reduction of AAV empty capsids. He is an inventor of four patent fillings on Pfizer-owned AAV purification technologies. William has authored six peer reviewed articles and given many presentations on purification process development. He holds PhD & MS degrees in Chemical Engineering from North Carolina State University and a BS in Chemistry from University of North Carolina Wilmington. Outside of work, William enjoys spending time with his family, serving at Shelter Church, running, and cheering for the Buffalo Bills.