Fast and flexible mRNA vaccine manufacturing as a solution to pandemic situations by adopting chemical engineering good practice : continuous autonomous operation in stainless steel equipment concepts

Schmidt, Axel GND; Helgers, Heribert; Vetter, Florian Lukas; Juckers, Axel; Strube, Jochen GND

SARS-COVID-19 vaccine supply for the total worldwide population has a bottleneck in manufacturing capacity. Assessment of existing messenger ribonucleic acid (mRNA) vaccine processing shows a need for digital twins enabled by process analytical technology approaches in order to improve process transfer for manufacturing capacity multiplication, a reduction in out-of-specification batch failures, qualified personal training for faster validation and efficient operation, optimal utilization of scarce buffers and chemicals and speed-up of product release by continuous manufacturing. In this work, three manufacturing concepts for mRNA-based vaccines are evaluated: Batch, full-continuous and semi-continuous. Technical transfer from batch single-use to semi-continuous stainless-steel, i.e., plasmid deoxyribonucleic acid (pDNA) in batch and mRNA in continuous operation mode, is recommended, in order to gain: faster plant commissioning and start-up times of about 8–12 months and a rise in dose number by a factor of about 30 per year, with almost identical efforts in capital expenditures (CAPEX) and personnel resources, which are the dominant bottlenecks at the moment, at about 25% lower operating expenses (OPEX). Consumables are also reduceable by a factor of 6 as outcome of this study. Further optimization potential is seen at consequent digital twin and PAT (Process Analytical Technology) concept integration as key-enabling technologies towards autonomous operation including real-time release-testing.

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Schmidt, Axel / Helgers, Heribert / Vetter, Florian Lukas / et al: Fast and flexible mRNA vaccine manufacturing as a solution to pandemic situations by adopting chemical engineering good practice. continuous autonomous operation in stainless steel equipment concepts. 2021.

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