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 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.
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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: http://go.nature.com/2aR1uu8 Nature Communications, online
July 29, 2016.
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