Abstract
Several epidemic and pandemic diseases have emerged over the last 20 years with increasing reach and severity. The current COVID-19 pandemic has affected most of the world’s population, causing millions of infections, hundreds of thousands of deaths, and economic disruption on a vast scale. The increasing number of casualties underlines an urgent need for the rapid delivery of therapeutics, prophylactics such as vaccines, and diagnostic reagents. Here, we review the potential of molecular farming in plants from a manufacturing perspective, focusing on the speed, capacity, safety, and potential costs of transient expression systems. We highlight current limitations in terms of the regulatory framework, as well as future opportunities to establish plant molecular farming as a global, de-centralized emergency response platform for the rapid production of biopharmaceuticals. The implications of public health emergencies on process design and costs, regulatory approval, and production speed and scale compared to conventional manufacturing platforms based on mammalian cell culture are discussed as a forward-looking strategy for future pandemic responses.
Highlights
The impact of the COVID-19 pandemic caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was foreshadowed by earlier epidemics of new or re-emerging diseases such as SARS (2002/2003), influenza (2009), Middle East Respiratory Syndrome (MERS, 2012), Ebola (2014/2015), and Zika (2016/2017) affecting localized regions (Bradley and Bryan, 2019; Kobres et al, 2019; Park et al, 2019)
Given the time required to develop and test a COVID-19 vaccine, the possibility that a vaccine may not be effective in all populations due to the variability of immune responses, and the likelihood that SARS-CoV-2 will mutate, we foresee an ongoing demand for therapeutic proteins, such as mAbs, immunoadhesins, interferons, and antivirals, to either target the virus itself or reduce the severity of the associated acute respiratory syndrome (Capell et al, 2020; Rosales-Mendoza, 2020)
Many companies have modified their production processes to manufacture urgently-required products in response to COVID19, including distillers and perfume makers switching to sanitizing gels, textiles companies making medical gowns and face masks, and electronics companies making respirators
Summary
The impact of the COVID-19 pandemic caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was foreshadowed by earlier epidemics of new or re-emerging diseases such as SARS (2002/2003), influenza (2009), Middle East Respiratory Syndrome (MERS, 2012), Ebola (2014/2015), and Zika (2016/2017) affecting localized regions (Bradley and Bryan, 2019; Kobres et al, 2019; Park et al, 2019). During a health emergency, such as the COVID-19 pandemic, regulatory agencies worldwide have re-assessed guidelines and restructured their requirements to enable the accelerated review of clinical study proposals, to facilitate clinical studies of safety and efficacy, and to expedite the manufacturing and deployment of re-purposed approved drugs as well as novel products (Tables 1 and 2).
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