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Technology. A disposable detector component for non-invasive
spectroscopic analysis of, and manufacturing control over, contents of sealed systems.
Potential Industry
Applications. Pharmaceutical manufacturing, food safety, bio-defense, and public health. APD Life Science's initial
focus is on manufacturers that produce disposable reactors for pharmaceutical manufacturing, a rapidly growing portion of
the bioreactor market that accounts for >$45B USD in product per year.
Design Advantages of ADP Life Science's
Detector Component. No need to open container to sample contents, capable of on-site analysis, no paper trail needed
to link test results to a given sampled container, "instant" availability of test results, and a fully loaded cost of 10%
to 15% of competitive detector methods.
Product Development. A lab scale detector system is
available for inspection. It has been developed to easily integrate into the wide variety of "fittings" used in the industry.
Capacity to monitor factors related to optimized cellular environment [e.g., pH and oxygen] and microbial contamination [bacteria
most often contaminating culture systems during extended growth] has been established. Additional analytical capabilities
are under development.
Patent Protection. Technology is based on three patents licensed from Penn
State University [first patent was issued in 1995 and the other two were filed in 2000 and 2004].
Regulatory.
The detector is not a drug, device, process, or biologic as defined by the FDA. Hence,it is not subject to direct FDA approval.
Each sub-licensee would rely, for their specific product applications, on prior FDA approval of the components of the detector
as to toxicity, leachability, etc.
Who is APD Life Science? A successor to BioPore, Inc., and formed
in 2003 by Roy H. Hammerstedt, PhD, an Emeritus Professor at Penn State University with 40 years of experience in chemistry/physiology.
Poised to license four technologies to end users on behalf of BioPore and/or APD Life Sciences. Developed and completed two
NIH Phase-II SBIR grants [detection of bacteria in platelet containers, and cryostorage of cells and tissues].
APD
Life Science's Business Model. Sub-license of core technology to sub-licensees, starting in the bio-pharma industry,
for manufacturing and distribution. Provision of application-specific consulting on an "as requested"; basis. See the APD
Life Science standard sub-licensing term sheet for key features to be negotiated.
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