Biosimilar MAb Production in Stainless Steel and Single-Use Bioreactors
H. Henry Lamb¹, Sharyn L. Farnsworth² and Stewart McNaull², (1)Chemical and Biomolecular Engineering, North Carolina State University, Raleigh, NC, (2)Upstream Process Development, Fujifilm Diosynth Biotechnologies, Cary, NC

A leachable compound in plastic bioprocess equipment that is detrimental to cell growth
Matthew Hammond, Amgen Inc, Thousand Oaks, CA

Break

Scale Free Manufacturing Model using Perfusion
Gael Peron¹, Wilson Lee¹ and Olivier Berteau², (1)Charter Medical, Ltd, Winston-Salem, NC, (2)APIcells Inc, Lowell, MA

Impact of Regulatory Guidances on Biopharmaceutical Cell Culture
Tom Kelleher, Global Process Engineering and Process Development, Amgen, Thousand Oaks, CA

Challenges Faced During the Flublok Approval Process
Penny Post, Regulatory, Protein Sciences Corporation, Meriden, CT