Process economics evaluation of cell-free synthesis for the commercial
manufacture of antibody drug conjugates
Abstract
Continuous improvements of cell-free synthesis (CFS) systems have
generated interest in adopting the technology for the manufacture of
biologics. This paper provides an evaluation of the manufacturing
cost-effectiveness of CFS for a range of commercial scenarios. The
evaluation was performed using an advanced techno-economic engine (TEE)
built in Python. The TEE is programmed in an object-oriented environment
capable of simulating a plethora of process flowsheets and predicting
size and cost metrics for the process and the facility. A case study was
formulated to compare the economics of whole bioprocesses based on
either a CFS system or a mammalian cell system (CHO) for the manufacture
of an antibody drug conjugate (ADC) at different commercial product
demand levels (100 – 1000kg/year). The analysis demonstrated the
potential of CFS for the commercial manufacture of biologics and
identified key cost drivers related with the system. The CFS system
showed approximately a two-fold increase in the cost of goods compared
to CHO with a significant cost attributed to the in-house manufacture of
the bacterial cell extract, necessary for the CFS reaction step in the
process. A sensitivity and target analysis highlighted the impetus for
further process improvements especially in the titre for the CFS process
to become more competitive against well-established systems.