Irisys LLC, a pharmaceutical contract manufacturing and development organization (CDMO), has announced its third contract for production and manufacturing in partnership with TFF Pharmaceuticals Inc., a clinical-stage biopharmaceutical company located in Austin, TX. Most recently, TFF Pharmaceuticals contracted with Irisys to manufacture an inhalable lung medication with the potential to treat COVID-19.
 
TFF Pharmaceuticals researches and innovates drug products based on its patented Thin Film Freezing, or TFF, technology platform. This freezing process creates dry powder formulations with properties ideal for inhalation and can potentially target SARS-CoV-2 inside the lungs by delivering medication directly to the infection site. TFF has compounds under development that can be used to treat challenging-to-manage lung conditions such as Invasive Pulmonary Aspergillosis, or IPA, and COVID-19.
 
TFF found Irisys to be a superior partner for the transfer of its technology to Irisys’ labs. Irisys will be responsible for the initial production and testing of TFF’s investigational powder product for inhalation. Irisys was able to help adapt the process to the needs of the project and to establish a robust manufacturing process suitable for clinical trial materials preparation.
 
“The most important part of this project is that we are not just helping develop a new formulation, but a new technology. With the versatility of this process, any lung therapeutic could potentially be applicable,” said JJ Sigler, Irisys scientist
 
The TFF platform was designed to improve solubility of poorly water-soluble drugs generally, and the technology is particularly useful in generating dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine.
 
The TFF process involves dissolving the drug in a solvent system, and then flash freezing the drug substance. The frozen powder is lyophilized, resulting in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments, the aerodynamic properties of the particles are such that the portion of drug deposited to the deep lung has the potential to reach as high as 75%.