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TFF Pharmaceuticals, Inc. (NASDAQ:TFFP) ("the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced the publication of research demonstrating the feasibility of intranasal delivery of monoclonal antibodies (mAbs) using the Company's proprietary Thin Film Freezing technology. The paper, entitled "Feasibility of Intranasal Delivery of Thin-film Freeze-dried Monoclonal Antibodies", was first published on October 24, 2023, by bioRxiv and can be found here.
More specifically, the research assessed the feasibility of applying the Company's Thin Film Freezing technology to convert mAbs into aerosolizable dry powders that can be delivered into the posterior nasal cavity using Aptar Pharma's Unidose (UDS) Powder Nasal Spray System. Based on the results of these studies, researchers concluded that, with proper formulation compositions, subjecting mAbs to Thin Film Freezing did not cause an increase in high molecular weight species and the mass percentage of proteinaceous particles remained below 2% weight concentration (w/w). Maintaining low molecular weight for droplet/particle size distribution is considered to be a critical attribute for effective delivery of intranasal liquid products.
"We are pleased with the results of this research, which provide further evidence that Thin Film Freezing can be applied across a board range of antibody-based drug candidates for intranasal delivery," said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. "While TFF Pharmaceuticals continues to focus on advancing its two lead clinical programs, TFF VORI and TFF TAC, there remains strong interest across a diverse group of academic, industry and government entities to assess intranasal drug delivery given its potential advantages of providing a less invasive, more targeted approach of delivering drugs."
"As a non-invasive delivery system, intranasal drug formulations hold many potential advantages over traditional, systemic-based delivery, including the potential for fast onset of action and reduced drug-related toxicities based on a more targeted approach," said Dr. Julie D. Suman, Vice President, Scientific Affairs at Aptar Pharma. "The publication of this research demonstrates the broad utility of our Unidose technology to effectively deliver biologic-based therapeutics to the posterior of the nasal cavity."
Posted In: TFFP
