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Client Profile
HTD Biosystems in partnership with the University
of Colorado Health Sciences Center.
Business Need
HTD was awarded a Phase I STTR (Small Business Technology Transfer
Grant) from the National Institute of Health (NIH) on Lung delivery of Nebulized Tissue Plasminogen Activator (tPA) to develop
a potential drug product for lung injury in Acute Respiratory Distress Syndrome (ARDS) patients. There currently is no effective
treatment for ARDS.
Technical Challenge
To develop a drug formulation that will sustain the nebulization process
and distribute adequately into the human respiratory tract. This required developing a suitable formulation of the drug product
that retained its biological activity after nebulization could be delivery efficiently into the human lung airways.
HTD
Services
With the Principal Investigator (Dr. Kathleen Stringer), we evaluated a number of formulations of tPA that could
be nebulized efficiently. We assessed the nebulized protein for biochemical, biophysical, and conformational stability using
a number of analytical techniques. The aerodynamic particle size was determined using a cascade impactor and biological activity
was determined by quantifying the ability of the agent to inhibit neutrophil reactive oxygen species (ROS) production in a
cell based assay. A potential formulation was characterized for the respiratory deposition following nebulization in a human
lung replica model.
Results
Both aims of the project were achieved successfully; by formulating tPA so that it
retained its biological and biochemical properties after nebulization and demonstrating efficient deposition of the nebulized
formulation in a human lung replica. Based on the success of these studies, NIH has recently awared HTD Biosystems with a
Phase II STTR grant to further develop this drug product for eventual commercialization.
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