Navigating Scale-Up Challenges in Protein Production

January 10, 2023

Parrish Galliher, an independent bioprocess consultant, speaks with moderator Ben Locwin, vice president of project solutions at Black Diamond Networks, about the context-dependent issues that arise when scaling-up protein production. Gallaher uses a case study involving scaling challenges in E. coli bioprocesses that produced a product at 50% potency. He also talks about the three main focus points every company should prioritize when assessing process development limitations, how to design scale-down studies to pinpoint causal factors, and how to use high-throughput screening for media optimization. Finally, he advises hiring first-rate process development experts to mitigate scaling issues from the start.

Parrish M. Galliher, MS, Independent Bioprocess Consultant
Parrish Galliher earned his BA in Biology at Boston University (1975) and MS degree in Biochemical Engineering at MIT (1981), after which he held technical management positions at Biogen, Inc., Alpha-Beta Technology, LeukoSite, and Millennium Pharmaceuticals. Galliher helped build and lead development, manufacturing, and CMC teams who developed scalable bioprocesses, built biomanufacturing facilities, and achieved commercial licensure of Avonex (beta-interferon) and CAMPATH monoclonal antibody. In 2002, he became Founder, President, and CEO of Xcellerex, Inc., a single-use technology and services company, at which he led the creation and commercialization of the single-use (SU) XDR mammalian and microbial bioreactor, XDM and XDUO SU mixing systems, and the turnkey SU modular FlexFactory biomanufacturing platform. In 2012, Xcellerex was acquired by GE Healthcare, at which Gallaher continued as Chief Technology Officer, Upstream, until 2021. During his tenure, he was awarded Bioprocess International’s 2012 “Thought Leader of the Decade, Upstream.” Gallaher has dedicated his career to the potential of biotechnology to transform human health and is a co-inventor of numerous patented inventions in the field of advanced, high efficiency biomanufacturing technologies. He is an independent bioprocess consultant in the biotech industry.