A simplified techno‐economic model for the molecular pharming of antibodies

By the end of 2017, the Food and Drug Administration had approved a total of 77
therapeutic monoclonal antibodies (mAbs), most of which are still manufactured
today. Furthermore, global sales of mAbs topped $90billionin2017andareprojectedtoreach$125 billion by 2020. The mAbs approved for human therapy are
mostly produced using Chinese hamster ovary (CHO) cells, which require expensive
infrastructure for production and purification. Molecular pharming in plants is an
alternative approach with the benefits of lower costs, greater scalability, and intrinsic
safety. For some platforms, the production cycle is also much quicker. But do these
advantages really stack up in economic terms? Earlier techno‐economic evaluations
have focused on specific platforms or processes and have used different methods,
making direct comparisons challenging and the overall benefits of molecular
pharming difficult to gauge. Here, we present a simplified techno‐economic model
for the manufacturing of mAbs, which can be applied to any production platform
by focusing on the most important factors that determine the efficiency and cost of
bulk drug manufacturing. This model develops economic concepts to identify
variables that can be used to achieve cost savings by simultaneously modeling the
dynamic costs of upstream production at different scales and the corresponding
downstream processing costs for different manufacturing modes (sequential, serial,
and continuous). The use of simplified models will help to achieve meaningful
comparisons between diverse manufacturing technologies.