Synthetic biology, biofoundries, and AI modeling could make vaccine production more sustainable and better prepare industry for pandemics, say some researchers. Until last year, vaccine manufacturing had not changed much in decades in terms of the technology the production methods used. The COVID-19 pandemic led to an entirely new manufacturing landscape. Efforts to develop and mass produce SARS-CoV-2 vaccine prompted industry to find faster, more efficient manufacturing methods.

Synthetic biology has been embraced by vaccine makers, according to Richard Kitney, PhD, a professor from Imperial College in London, who cites Moderna and Pfizer-BioNTech’s mRNA COVID-19 shots as examples.

“Both vaccines were designed and implemented using synthetic biology techniques,” he tells GEN. “With these vaccines it was possible to design them to specifically mimic the virus at the molecular level and hence to provide to the body’s immune system with a direct template to which the immune system could react.”

In the case of Moderna, Boston-based synbio company Ginkgo Bioworks reports that it did help from a manufacturing perspective.

One advantage is the ability to modify future iterations of the vaccine against new strains, according to Kitney, who says, “The strategy here is similar to that of addressing different strains of flu but is much more systematic.”

Biofoundries

Synthetic biology has also impacted manufacturing by letting producers switch from traditional production approaches to biofoundries—highly efficient, automated, and scalable production systems, Kitney says.

“There are a range of different methods based in synthetic biology for the production of vaccines, which are not based on traditional methods,” he continues. “In the case of the mRNA vaccines, the number of doses that can be obtained from a given volume of broth is significantly greater than that for traditional vaccines.”

The biofoundry approach has application beyond COVID-19, according to Kitney.

“It should be possible to design production facilities that are significantly based on the biofoundry technology that is now being used in synthetic biology,” he says. “It is therefore feasible to install such a production facility in, for example, a university for research facility in Africa and to control it remotely across the Internet.

“This has the potential for minimal human intervention and high levels of reliability and reproducibility. Hence, the vaccine design would be undertaken in one or more geographical locations and then downloaded to the distributed manufacturing facilities.”

Distributed manufacturing

Kitney and colleagues looked at distributed manufacturing in a paper published earlier this year. The key finding says co-author Jennifer Bell, PhD, from International Pharmaceutical Quality in Gothenburg, Sweden, is that distributed manufacturing can make vaccines available to more people.

“Centralized vaccine production is ideal in geographies with strong supply chain networks,” she says.” Distributed manufacturing is better suited to regions that are difficult to supply to. The distributed manufacturing model in the paper would decrease supply chain expenditure and risks for those regions.”

The distributed manufacturing model is already used in the pharmaceutical industry and could be easily adopted by vaccine producers, according to Bell.

“Pharma companies already use the distributed manufacturing model in their operations. Although the extent that distributed manufacturing is used is not widely known. Radiopharmaceuticals are produced under a distributed manufacturing model,” she explains. “A large vaccine manufacturing company already has a lot of in-house operations experience in relation to vaccine production that could be transferred to the distributed manufacturing model.”

Again, the approach is better suited for the production of some vaccines than others, points out Kitney, who adds, “It will be very attractive to governments around the world and COVAX-WHO. The global pandemic of COVID-19 has produced major economic disruption and this is not something that the international governmental community will want to repeat. There are already indications, for example in the Biden Administration, that the type of distributed manufacturing techniques will be readily adopted.”