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Process economics evaluation of cell-free synthesis for the commercial manufacture of antibody drug conjugates
  • Christos Stamatis,
  • Suzanne Farid
Christos Stamatis
University College London
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Suzanne Farid
University College London
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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.

Peer review status:UNDER REVIEW

30 Apr 2020Submitted to Biotechnology and Bioengineering
02 May 2020Assigned to Editor
02 May 2020Submission Checks Completed
12 May 2020Review(s) Completed, Editorial Evaluation Pending