(Reuters Health) - A portable system that produces tiny batches of biotech drugs might one day help get crucial medicines and vaccines to remote villages and war-torn regions where they’re desperately needed, scientists hope.
While the manufacturing process is still experimental and may not be cheap, it could provide a way to produce single doses of medicines and vaccines on demand - even in places where biotech drugs are often unavailable because they are difficult to transport and store.
“They typically require refrigerated trucks transporting drugs across borders, which is an expensive and sometimes dangerous process,” said senior study author Timothy Lu, a researcher at the Massachusetts Institute of Technology in Cambridge, Massachusetts.
“Similarly, in war zones or in case of natural disasters, the transport routes may be compromised for long periods of time,” Lu added by email. “Additionally, after transporting drugs, refrigeration may be needed to preserve the drug until it’s used.”
The solution might be a portable production system that can make a single dose of liquid medicine from a machine containing programmable yeast cells, researchers report in Nature Communications.
So far, this strain of yeast, Pichia pastoris, has been used to make two proteins with therapeutic uses: recombinant human growth hormone (which can treat short stature caused by a number of disorders) and interferon (which can treat a variety of viruses and cancers).
The table-top machine has the potential to one day produce proteins to treat any number of a wide range of conditions like cancer, diabetes, heart attacks, and hemophilia, Lu said.
There are several hurdles ahead, including the need for regulatory approval to manufacture drugs in this way.
Researchers are currently redesigning the manufacturing process from the ground up because there is no precedent for this sort of tiny batch production.
One advantage would be the potential to make multi-component vaccines using one manufacturing platform, noted Charles Schroeder, a scientist at the University of Illinois at Urbana-Champagne who wasn’t involved in the research.
Even though small batch production would be much more expensive than making similar medicines in factories, the idea does have the potential to benefit patients in remote locations, Schroeder added by email.
It will be no small task, however, to make sure the raw ingredients aren’t damaged or contaminated.
“These natural materials are easily degradable and require precise and controlled conditions for storage, preparation, and transport,” Schroeder said. “With even a slight perturbation in the environmental controls, a batch of biologics could degrade and become unusable.”
The finished vaccines and medicines can also degrade easily because they are made from living cells, potentially making them ineffective, Eric Johnson Chavarria, a scientist at Yale University in New Haven, Connecticut who wasn’t involved in the research, said by email.
If more research and field tests show this type of production is safe and effective, it has a lot of potential to transform the type of care available in places where people can’t easily find a drugstore to fill a prescription for biotech therapies.
“This work represents an important step forward in the small-scale production of biologics, and, if successful, may be used in remote locations for production of complex biologics,” Schroeder said.
But, he added, “More work needs to be done before implementation of clinical trials.”
SOURCE: go.nature.com/2aR1uu8 Nature Communications, online July 29, 2016.
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