Abstract
The COVID-19 pandemic has motivated the rapid development of numerous vaccines that have proven effective against SARS-CoV-2. Several of these successful vaccines are based on the adenoviral vector platform. The mass manufacturing of these vaccines poses great challenges, especially in the context of a pandemic where extremely large quantities must be produced quickly at an affordable cost. In this work, two baseline processes for the production of a COVID-19 adenoviral vector vaccine, B1 and P1, were designed, simulated and economically evaluated with the aid of the software SuperPro Designer. B1 used a batch cell culture viral production step, with a viral titer of 5 × 1010 viral particles (VP)/mL in both stainless-steel and disposable equipment. P1 used a perfusion cell culture viral production step, with a viral titer of 1 × 1012 VP/mL in exclusively disposable equipment. Both processes were sized to produce 400 M/yr vaccine doses. P1 led to a smaller cost per dose than B1 ($0.15 vs. $0.23) and required a much smaller capital investment ($126 M vs. $299 M). The media and facility-dependent expenses were found to be the main contributors to the operating cost. The results indicate that adenoviral vector vaccines can be practically manufactured at large scale and low cost.
Highlights
The well-known proverb, “necessity is the mother of invention” certainly describes the recent experience with the unprecedented development speed of SARS-CoV-2 (COVID-19) vaccines
As noted in the table, these vaccines are based on four different vaccine platforms: inactivated virus, protein subunit, adenovirus vector and messenger RNA
Most of the COVID-19 vaccine candidates, outside of the inactivated virus category, incorporate the spike protein with three different strategies employed for the leading COVID-19 candidates: protein subunit, adenovirus vector and messenger RNA (mRNA). These platforms are briefly described in the following paragraphs, with an emphasis on the adenovirus vector platform which is the object of the present study
Summary
The well-known proverb, “necessity is the mother of invention” certainly describes the recent experience with the unprecedented development speed of SARS-CoV-2 (COVID-19) vaccines. As noted, these vaccines are based on four different vaccine platforms: inactivated virus, protein subunit, adenovirus vector and messenger RNA (mRNA). Vaccines utilized highly attenuated pathogens, incapable of causing severe infections yet providing enough exposure to develop immunological memory and protection against future exposure This strategy is still used today and employed in development of several COVID-19 vaccines. While vaccine development in the early days was a “hit or miss” strategy, with the tools available today to probe biology and intervene at the molecular level, many new vaccine strategies have emerged These emerging vaccine platforms do not require the inactivated virus but rather target portions of the virus leading to inherently safe products with accelerated development times. These platforms are briefly described in the following paragraphs, with an emphasis on the adenovirus vector platform which is the object of the present study
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