Aphios
Awarded United States Patent For Polymer Drug Delivery Nanotechnology
Equipment
Woburn,
MA — December 06, 2011 —Aphios Corporation
today announced that it was awarded United States Patent
No. 8,070,467 for “Polymer Microspheres/Nanospheres
and Encapsulating Therapeutic Proteins Therein,” granted
December 06, 2011. This invention is for equipment to implement
an improved process to formulate polymeric microspheres
and nanospheres, and encapsulate therapeutic proteins or
other useful substances, and a polymer microspheres/nanospheres
apparatus. This invention also entails equipment for purifying
protein-containing polymeric microspheres/nanospheres from
unused polymer and an apparatus therefore.
Conventional large-scale production of polymeric microspheres
utilizing numerous processing steps and large quantities
of organic solvents is very time consuming, costly and inefficient.
In addition, the exposure of therapeutic agents to organic
solvent adversely effects protein integrity and bioactivity.
The uniformity and integrity as well as processing time
and the cost associated with preparation of biodegradable
polymer microspheres containing therapeutic products are
greatly reduced by using supercritical fluids, critical
or near-critical fluids with or without polar cosolvents
[SuperFluids™].
“In our SuperFluids™
polymer nanospheres (PNS) process, a biodegradable polymer
such as PLGA is dissolved in SuperFluids™ and mixed
with the target therapeutic in solution or as a slurry of
nanoparticles at operating pressures.” says Dr. Trevor
P. Castor, President & CEO of Aphios Corporation. “The
mixture is then decompressed through a nozzle into an aqueous
solution, liquid nitrogen or an empty vessel (spray dryer).
Polymer nanospheres are formed encapsulating the protein
therapeutics,” he explains. Alternatively, the polymer-enriched
SuperFluids™ stream can be decompressed into an aqueous
solution containing the target therapeutic agent. In addition
to reduction or elimination of organic solvent usage, use
of SuperFluids™ for making nanospheres imparts advantages
of no residual toxic organic solvent and pathogen safety.
“The SuperFluids™ PNS process can be utilized
to encapsulate therapeutic proteins and other molecules
without utilizing organic solvents as is traditionally done,”
continues Dr. Castor. By changing nozzle design and process
parameters, the process can also be utilized to manufacture
polymer microspheres. SuperFluids™ PNS is a single-step
process that is readily scalable. “SuperFluids™
PNS can be utilized for improving the oral bioavailability
of peptides and proteins, depot delivery of peptides and
proteins for sustained, controlled release and the subcutaneous
and/or oral delivery of sensitive vaccine antigens,”
he concludes.
Aphios® Corporation, Woburn, MA is a “green”
biotechnology company developing enabling technology platforms
for improved drug discovery and manufacturing, nanotechnology
drug delivery and pathogenic drug safety. Using these enabling
technology platforms, Aphios and its collaborators are developing
enhanced therapeutics for health maintenance, disease prevention
and the treatment of certain cancers, infectious diseases
and Central Nervous System (CNS) disorders.
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