Franz Gerner, PhD

Franz leverages more than 25 years of experience in viral gene therapies, specializing in CMC and associated areas.

He has supported multiple projects from R&D stage to late-stage, establishing internal capabilities as well as working extensively with external vendors.

Franz brings significant expertise in the development, technology transfer and execution of manufacturing process of viral vectors including the associated analytics, formulation strategies, device evaluation and device compatibility, as well as storage and shipment of viral drug substances/products and plasmids.

Professional Background

Franz has been working since the mid-1990s in the field of gene therapy with increased responsibilities in CMC, Supply Chain and Quality Assurance for viral gene therapy vectors.

He most recently held the position of Chief Technology Officer at Excision BioTherapeutics, where he was overseeing the Technical Operation strategies and activities for multiple viral and non-viral based gene therapy programs. He was responsible for oversight and overall coordination of external vendor strategies and interactions for Drug Product/Analytical Development, Manufacturing, Quality Control, Supply Chain and Quality Assurance. Franz coordinated timelines and activities with internal stakeholders for efficient program advancement.

From his previous position as Vice president of Technical Operations at Sio Gene Therapies, Franz offers skills in leading to successful and efficient development, manufacturing, analytical and Supply Chain activities for late stage AAV-based programs.

As previous Senior Director of Process Development as well as Technical Innovation and New Technologies at Regenxbio, he offers experience not only of classic Process and Analytical Development for viral vectors, but beyond this of identifying selecting, evaluating and implementing new technologies to improve the yield and quality of viral vector products. His expertise in identification and execution of viral vector design improvements, as well as process improvements, were leading to significant enhanced performance of viral vector manufacturing. In addition, having overseen technology transfers to different CDMOs, he supports clients in selecting suitable manufacturers and help with technology transfers.

Franz held previous positions at the CDMO Ominia Biologics and at Wellstat Ophthalmics, after completing his Ph.D. thesis about improvements in AAV manufacturing at the Ludwig-Maximilians-University in Munich, Germany