Biopharma Battlefield
Can portable kits manufacture on-demand biopharma medicines for remote soldiers?
Biopharmaceutical medicines remain demanding in terms of manufacture and storage, meaning that they are not readily available in all locations. How do you get much-needed biologics to soldiers fighting in remote locations, for example?
A number of research teams are working on that issue, with funding from the US Defense Advanced Research Projects Agency (DARPA). DARPA has proposed that miniaturized synthesis and manufacturing platforms that make medicines on demand could be the answer.
One such platform, developed by scientists at MIT as part of the Bio-MOD (Biologically-derived Medicines on Demand) initiative, uses programmable yeast cells to produce therapeutic proteins (1). The researchers genetically modified the yeast strain Pichia pastoris so that it is able to produce one of two proteins, depending on which chemical trigger the cells are exposed to. When exposed to estrogen β-estradiol, the cells produce recombinant human growth hormone (rHGH), but when exposed to methanol, the cells produce interferon-α2b.
The yeast cells are contained within a table-top microbioreactor that contains a microfluidic chip. The device continuously monitors oxygen levels, temperature and pH to ensure the optimum environment for yeast cell growth. If a different protein is required, the liquid medium is simply flushed through a filter, retaining the yeast cells (unlike other microbioreactors). Fresh medium, containing the new trigger chemical, can then be added to start production of the required protein.
Another project funded by DARPA is the work of Govind Rao, a professor of chemical and biochemical engineering at the University of Maryland, Baltimore County, and his collaborators at Ohio State University, Thermo Fisher Scientific, and Latham Biopharm. Rao has developed a portable briefcase-sized kit that produces FDA-approved biologics on-demand (2). Rao’s kit is different in that it does not require live cells and instead relies on Thermo Fisher Scientific’s cell-free expression platform to produce biologics in a matter of hours.
According to Rao, Bio-MOD program manager, Colonel Geoffrey Ling, has personally experienced an unreliable medicine supply chain in remote areas of Afghanistan. “Ling decided to challenge the scientific community to come up with a solution to the problem by inventing technology that would produce protein drugs, at the point-of-care, in under 24 hours,” he says.
Rao and his team are now working on making the device robust enough to withstand harsh warzone environments. But the battlefield is only one application of the DARPA-funded projects – it could also be used to revolutionize the availability of advanced therapeutics to low-resource countries or, in the hands of researchers, to empower faster discoveries of products for rare diseases.
- P Perez-Pinera et al., “Synthetic biology and microbioreactor platforms for programmable production of biologics at the point-of-care”, Nature Communications, 7, 12211 (2016).
- UMBC, “DARPA awards CAST $8M for new phase of drug delivery project,” (2015). Available at: bit.ly/2bfEvJH. Last accessed August 10, 2016.
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