Avirmax Inc

Stephen Garger

Stephen Garger is an accomplished leader of cross-functional scientific teams that succeeded in the biological process development, optimization and cGMP manufacturing of recombinant biopharmaceuticals and gene therapy products using mammalian cell culture and plant-based expression systems. He has a broad-base of experience within a regulated environment including the representation of CMC at pre-IND, scientific advice and pre-approval meetings with the FDA, EMA, PEI, MPA and MHRA. He prepared the CMC section of multiple INDs, BLAs and MAAs, led the manufacturing teams that produced Phase I through Phase III clinical materials in therapeutic antibodies, recombinant factor VIII (F8) and early stage of AAV vector-based F8 gene therapy of hemophilia A. Mr. Garger has 35 US patents in the areas of recombinant protein expression, purification, specific protein therapeutics and vaccines. He served as the editorial board member for the Journal of Industrial Microbiology and Biotechnology (1996-1999). He was the Director of Isolation and Purification department, Global Biological Development of Bayer Pharmaceuticals, a Vice President of Large Scale Biology Corporation.