Monoclonal Antibody Manufacturing: Transforming Our Most Important Biologics Manufacturing Process from an Artform to a Science
"Monoclonal Antibody Manufacturing: Transforming Our Most Important Biologics Manufacturing Process from an Artform to a Science"
Olav Lyngberg, PhD.
Senior Scientific Fellow,
Janssen Pharmaceutical, a Johnson & Johnson Company
Meeting Link: https://primetime.bluejeans.com/a2m/live-event/gfhbcxgx
Abstract: This lecture focuses on monoclonal antibody manufacturing and its challenges as we transform biologics manufacturing from an artform to a science and thereby address key societal needs around access, assurance of supply and use of biologics in high dose indications.
As we transition from mAbs being new niche drugs to main stays of modern medicine, it is appropriate to examine how we move mAb manufacturing from the art form it has been to the science it must become. In doing so we seek to address the relative high cost of manufacturing, the slow pace of technical transfers, the lack of manufacturing flexibility and finally we endeavor to understand quality throughout the process. These changes will enable broader use in indications with high dose requirements and better address worldwide assurance of supply. We seek to accomplish these goals by developing more intensified processes, executing in modular and flexible equipment while applying advanced process control and real time release to ensure enhanced quality control.
Bio: Olav holds a Ph.D. in chemical engineering from the University of Minnesota where he studied under Professors Scriven and Flickinger. He holds a Master of Science degree in Chemical Engineering from The Technical University of Denmark where he studied with Prof. Jens Nielsen.
Olav started his industrial career in chemical development with Bristol-Myers Squibb in 2000. During his tenure with Bristol-Myers Squibb he among other things pioneered the use of mechanistic and engineering-based modeling for small molecule active pharmaceutical ingredient process development. He also led an effort to develop and implement a rigorous FMEA based process risk assessment approach and he served as the CMC lead for several neuroscience drug candidates.