Transcript Document

Grand Challenges in
Global Health
AKTIV-DRY
6060 Spine Road  Boulder CO 80301
303-350-3060  www.aktiv-dry.com
The Project
The Collaboration
Aktiv-Dry is a proud participant in the Grand
Challenges in Global Health Initiative. Our project
addresses the Third Grand Challenge: Develop
needle-free delivery systems for vaccines. Our
specific approach is to develop a stable, dry micropowder measles vaccine that will be administered by
inhalation to patients in developing economies.
Aktiv-Dry is the system integrator and responsible
for project management.
We also lead the
development of the PuffHaler DPI and participate
in micro-powder vaccine formulation using the
CAN-BD process.
Achieving this goal requires that we
• Reformulate an existing Edmonston- Zagreb (EZ)
measles vaccine (currently administered by needle
and syringe) as a stable dry powder consisting of
particles with aerodynamic diameters between 1 and
5 microns,
•
Develop human-powered, single-use delivery
devices costing no more than 10¢ per dose,
•
Demonstrate safety (toxicity) and efficacy
(immunogenicity) in pre-clinical trials,
• Scale-up our CAN-BD Bubble Dryers®, build them
to cGMP specifications, and transfer the technology
to the Indian vaccine manufacturer,
• Demonstrate safety in Phase I clinical trials in the
year 2010.
The Serum Institute of India Ltd (SIIL) provides its
EZ measles vaccine and plays a key role in
reformulation activities.
SIIL also bears
responsibility for manufacturing the dry powder
vaccine for use in pre-clinical and clinical trials.
The University of Colorado leads the formulation
of the measles vaccine as a dry and stable micropowder.
National Jewish Medical and Research Center
undertakes research with small animals to
demonstrate pulmonary deposition and viral
replication.
Becton Dickinson Technologies is developing a
second DPI, the Solovent®.
Other contributions have been made by Johns
Hopkins University, the University of Kansas, The
Foundation for the National Institutes of Health,
the World Health Organization, and a cadre of
consultants from industry and academe.
QuickTime™ and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
Causes of vaccine-preventable deaths among
children < 15 years, 2000
(From the World Health Organization)
A Humanitarian Project To Save Lives In The Developing World