A role for Biofoundries in rapid development and validation of automated SARS-CoV-2 clinical diagnostics

Crone, Michael; Priestman, Miles; Ciechonska, Marta; Jensen, Kirsten; Sharp, David J.; Anand, Arthi; Randell, Paul; Storch, Marko; Freemont, Paul S.

doi:10.1038/s41467-020-18130-3

Cited by 59 publications

(61 citation statements)

References 27 publications

(35 reference statements)

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“…In projects where high-throughput, reproducible results are demanded over short time frames automation has significant advantages over manual procedures. Recently a highly automated biofoundary, normally with a focus on research applications, was repurposed towards the development of SARS-CoV-2 assays for clinical diagnostics (Crone et al, 2020). Automated liquid handling equipment was able to perform an extensive array of experimental procedures at a rate in excess of those that a manual based laboratory could carry out.…”

Section: Examples Of Automation Benefitsmentioning

confidence: 99%

Automation in the Life Science Research Laboratory

Holland

Davies

2020

Front. Bioeng. Biotechnol.

100

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Section: Examples Of Automation Benefitsmentioning

confidence: 99%

Automation in the Life Science Research Laboratory

Holland

Davies

2020

Front. Bioeng. Biotechnol.

100

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“…The approach chimes with the distributed supply chains and distributed manufacturing that could be transformative in dealing with COVID-19 and future pandemics throughout the world. The potential of the approach was demonstrated by Crone and co-workers [ 22 ] who showed that an automated SARS-CoV-2 clinical diagnostics platform designed and developed in a biofoundry can be quickly deployed and scaled.…”

Section: The Synthetic Biology Approach Lends Itself To a Distributedmentioning

confidence: 99%

“…The recently formed Global Biofoundries Alliance [ 23 ] has publicly funded biofoundries in North America, Europe, Asia, and Australia, which could be brought to bear for the design of new vaccines, as needed. As pointed out by Crone and co-workers [ 22 ], the protocols and workflows they developed can be quickly incorporated and modified as necessary by members of the Global Biofoundry Alliance. Box 2 shows front-running approaches to vaccine production that are highly amenable to the synthetic biology approach.…”

Section: The Synthetic Biology Approach Lends Itself To a Distributedmentioning

confidence: 99%

Build a Sustainable Vaccines Industry with Synthetic Biology

Kitney

Bell²,

Philp

2021

Trends in Biotechnology

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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...

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“…163 Obviously, continued development of these processes will enable better evaluation of how RT-LAMP holds up relative to other strategies, but initial reports are encouraging. 164 However, the low technical requirements render this strategy applicable to low technology level areas that are in need of rapid and cheap tests that are simple to run. It should be noted that one issue with such strategies is product contamination across samples, although some approaches have been proposed to minimize this issue.…”

Section: Reverse Transcription Polymerase Chain Reaction (Rt-pcr)mentioning

confidence: 99%

Science’s Response to COVID-19

Aye¹,

Long²

2021

Preprint

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CoVID-19 is a multi-symptomatic disease which has made a global impact due to its ability to spread rapidly, and its relatively high mortality rate. Beyond the heroic efforts to develop vaccines, which we will not discuss, the response of scientists and clinicians to this complex problem has reflected the need to detect CoVID-19 rapidly, to diagnose patients likely to show adverse symptoms, and to treat severe and critical CoVID-19. Here we aim to encapsulate these varied and sometimes conflicting approaches and the resulting data in terms of chemistry and biology. In the process we highlight emerging concepts, and potential future applications that may arise out of this immense effort.

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A role for Biofoundries in rapid development and validation of automated SARS-CoV-2 clinical diagnostics

Cited by 59 publications

References 27 publications

Automation in the Life Science Research Laboratory

Automation in the Life Science Research Laboratory

Build a Sustainable Vaccines Industry with Synthetic Biology

Science’s Response to COVID-19

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