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News
CritiTech announces qualification
of a new GMP production facility in Lawrence, Kansas
March 13, 2007
FOR IMMEDIATE RELEASE
LAWRENCE , Kansas- Today, Sam Campbell , President and CEO
of CritiTech, Inc., announced successful qualification of
a new Crystallization facility for Good Manufacturing Practices
( GMP ) production of Active Pharmaceutical Ingredients (
API ) for Phase I Clinical Trials. Campbell stated that “this
completes a major milestone for our company as we move toward
Clinical Trials for Nanotax, a drug we have developed for
treatment of Ovarian Cancer.” Phase I of these trials
will be conducted by the Kansas University Medical Center
.
Many drug compounds, especially those used in the treatment
of cancer are very difficult to make soluble so they can be
administered to patients. Often a drug must be combined with
a harsh solvent to deliver the drug effectively. These solvents
can be highly toxic to patients and cause many of the adverse
reactions known to accompany chemotherapy. CritiTech has developed
methods of crystallizing cancer drugs into uniform microscopic
particles which will allow suspension of these drugs in water.
The replacement of the harsh solvent delivery system with
water will dramatically reduce the adverse affects of chemotherapy,
and will expand the number of patients that can be treated.
CritiTech believes the crystallization process used for Nanotax
will pave the way for the development of other cancer compounds.
CritiTech’s technology can be applied to non-cancer
drugs as well.
A facility with Good Manufacturing Practices, or “ GMP
” production capability is recognized by the FDA as
having the proper equipment and technical expertise to produce
API for human applications. The ability to produce GMP material
has thrust CritiTech into the forefront of a handful of international
companies that can successfully produce API in submicron (nanoparticle)
sizes.
CritiTech’s laboratory operations are located at 4950
Research Park Way , in Lawrence , Kansas . CritiTech was formed
in 1997 by the University of Kansas Center for Research
and the Higuchi Biosciences Center as an outgrowth of ground-breaking
research in Super-Critical Fluid technology conducted by Dr.
Bala Subramaniam at the Kansas University School of Engineering.
CritiTech has continued to expand its efforts in critical
drug delivery and development technology for the pharmaceutical
industry. CritiTech’s core technology centers around
using compressed carbon dioxide as a processing medium to
produce relatively residue-free and uniform drug nanoparticles
and coatings.
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