Build a Sustainable Vaccines Industry with Synthetic Biology

Abstract

The vaccines industry has not changed appreciably in decades regarding technology, and has struggled to remain viable, with large companies withdrawing from production. Meanwhile, there has been no let-up in outbreaks of viral disease, at a time when the biopharmaceuticals industry is discussing downsizing. The distributed manufacturing model aligns well with this, and the advent of synthetic biology promises much in terms of vaccine design. Biofoundries separate design from manufacturing, a hallmark of modern engineering. Once designed in a biofoundry, digital code can be transferred to a small-scale manufacturing facility close to the point of care, rather than physically transferring cold-chain-dependent vaccine. Thus, biofoundries and distributed manufacturing have the potential to open up a new era of biomanufacturing, one based on digital biology and information systems. This seems a better model for tackling future outbreaks and pandemics. The Vaccine Production Model Needs to ChangeThe COVID-19 crisis has cast the vaccines industry into scrutiny [1]; an industry that has been silently beleaguered for decades (https://www.who.int/immunization/programmes_systems/ procurement/mi4a/platform/module2/2019_Global_Vaccine_Market_Report.pdf?ua=1). A United States National Academy of Sciences study from 2003 [2] concluded that the amount that the nation spent on vaccines 'appears to be insignificant compared with that spent on other medical and social interventions that may have lesser social benefits.' Large company numbers that supply vaccines have steadily reduced [3]: some 80% of vaccines arise from five multinationals (https://www.who.int/immunization/programmes_systems/procurement/market/ global_supply/en/). At the heart of the problem is a tension between relatively poor financial returns to the vaccine industry and the high costs in production and R&D [4].Compared to small molecule pharmaceuticals, centralised vaccine production facilities are capital intensive [5]. Fixed costs are high [6], especially for new vaccines. For example, the need for eggs for production is at least 70 years old, is expensive and time-consuming, but difficult to replace [7]. In past high-income countries have paid a higher price until the fixed costs are amortised. Then lower-income countries have adopted vaccines as the price has dropped after paying the fixed costs. However, there is now tremendous pressure for a COVID-19 vaccine to be available for all who need it, effectively everyone. Distributed Manufacturing, a More-Sustainable Vaccine ModelThe long distribution chains of centralised vaccine production are patchy, resulting in incomplete geographical coverage [8] (Box 1). Even if there is no overall shortage, there may be where they are needed most. Centralisation of labour and production has been the norm in many industries, but in 2015 the World Economic Forum (WEF, see Glossary) put distributed manufacturing in its top ten emerging technologies for the year (https://www.weforum.org/agenda/2015/03/top- HighlightsBiofoun...

Addressing the post‐COVID era through engineering biology

“…Our conclusion is that there is now the potential to enter a new world of low carbon economies, coupled with systematic bio design and bio manufacturing—through synthetic biology engineering biology—that lends itself to distributed manufacturing [ 87 ].…”

“…11 Fish vaccines have been produced by rather conventional vaccine technology in the past. Like with human vaccines [ 87 ], biotechnology and synthetic biology approaches to new fish vaccines show the greatest potential for further improvements [ 88 ].…”

Bioinformational trends in grape and wine biotechnology

“…Twenty years of research and development enabled biofoundries to pivot when the COVID-19 outbreak manifested [79,80]. Several member foundries of the Global Biofoundries Alliance (GBA) and the International Gene Synthesis Consortium (ISCG) pivoted in response to COVID-19.…”

Exploring presentations of sustainability by US synthetic biology companies

“…Synthetic biology is a 21st-century approach to genetic engineering focused on developing infrastructure (tools, methods, platforms) and know-how for the systematic design and construction of genetic components, circuits, and organisms to carry out specific functions. It is being presented as enabling transformative advances across the biotechnology sector, including in food and agriculture [1,2], drug and vaccine discovery and production [3,4], material sciences [5,6], and data storage [7]. Roles for synthetic biology are also being advanced for environmental challenges including climate change [8] and biodiversity conservation [9].…”