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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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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:Published

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
Apr 2021Published in Biotechnology Journal volume 16 issue 4 on pages 2000238. 10.1002/biot.202000238