Generation and Delivery of Aerosols
KAER™provides services and devices for the generation and delivery of respirable aerosols. KAER’s primary competitive advantage is in the generation and delivery of high concentrations of aerosols of large labile molecules.
KAER addresses the needs of the biopharmaceutical and toxicological industries.
KAER’s SUPRAER™is a patented new class of aerosol delivery system. In this system, a large liquid aerosol is generated with a low-shear nozzle, dried, concentrated and delivered on demand. The dose rates are 5 to 10 ten times higher than current nebulizer technologies. SUPRAER extends the range of molecules and organelles that can be aerosolized to form fine particle aerosols. These include, antibodies, antibody drug conjugates, fusion proteins, surfactants, oligonucleotides, cellular organelles and viruses. KAER’s proprietary aerosol generation technologies are also applicable to the generation of aerosols of cells and cellular organelles.
In recognition of the superiority of SUPRAER’s technology over those from the top competitive companies, together with its importance and impact on drug delivery, Frost and Sullivan awarded KAER Biotherapeutics their 2012 North American Technology Innovation Award for Aerosol Drug Delivery
Treatment of Lung Diseases by Aerosol Inhalation
Lung diseases that are being treated or destined to be treated with biotherapeutics include cancer, obstructive lung disease, asthma, cystic fibrosis, pulmonary fibrosis and pneumonia. The IV route is most often chosen because of the delivery limitations of present aerosol delivery systems. Intravenous administration not only has considerable patient resistance, but its own attendant complications. Given the high molecular weight of many of these agents, large doses are often required to achieve acceptable therapeutics levels. The treatment of lung diseases with such large masses (tens to hundreds of milligrams) of biotherapeutic aerosols has presented formidable technical challenges. The introduction of SUPRAER™ fulfills this need. KAER utilizes this SUPRAER platform technology to form partnerships with pharma to deliver their biotherapeutic directly to the lungs.
Aerosol delivery via the respiratory tract is the preferred mode of administration for lung diseases. Intravenous administration may require 5 to 10 times the dose of that delivered directly to the lung via inhalation. The ability to rapidly deliver high doses of therapeutics to the lung via inhalation provides direct access to the target organ while markedly reducing the total dose of the agent, cost of therapy, as well as the potential for systemic side effects.
It is notable that development of biologic agents comprise half of drugs in the pharmaceutical pipeline. These biotherapeutics include, proteins,fusion proteins, peptides, surfactants, oligonucleotides, antibodies,antibody drug conjugates, plasmids, vaccines and liposomes. In addition, there are other agents and large unstable molecules in which large masses are required to be deposited in the lungs for effective therapeutic results. New therapies could included the aerosol delivery of stem cells and cellular organelles.
The delivery of tens to hundreds of milligrams of therapeutic agents presents formidable barriers and practical issues for present liquid or dry powder aerosol delivery systems. These issues include, low output with very long patient treatment times, structural and functional degradation of the active ingredient as well as the need to add large amounts of excipients to create suitable aerosols and maintain long-term stability. In addition, there can be considerable variation in the dose deposited in the lungs.
SUPRAER™ has clear competitive advantages in the treatment of lung diseases that require large therapeutic doses of the biotherapeutics:
- Conversion of administration from IV to inhalation enables an 80-90% reduction in dose.
- Aerosol delivery at rates up to 20 fold higher than current nebulizers results in far shorter treatment times.
- Respirable aerosols of higher molecular weight compounds and more viscous solutions can be generated with SUPRAER than with other nebulizers
- Aerosolization rate and particle size are tailored to achieve the desired dose and targeted regional lung deposition
- The aerosol is delivered continuously throughout each and every inhalation, rather than a bolus, thus delivering a much higher dose for each and every breath.
- To date no molecular or functional degradation of the aerosolized biologics has been observed.
- Hollow pure protein respirable aerosol can be delivered up to 2 mg/s
- The current IV biologic formulations can be used for aerosolization. No additional excipients are required, enabling savings in formulation, development time and safety testing costs
- Adoption of SUPRAER can result in improved patient care and lower healthcare costs.
Short treatment times lead to a cascade of benefits to the patient as well as healthcare providers
The short treatment times using SUPRAER initiates a positive cascade of benefits that flow through the healthcare chain and in turn drive biopharma's product sales. The paradigm change from intravenous (IV) to inhalation administration for lung disease treatments results in an 80% reduction of the dose of biotherapeutic administered. Patients experience shorter treatment times and fewer side effects along with improved efficacy and treatment adherence. Healthcare providers enjoy more effective utilization of resources and insurance agencies reduced costs. There is a sizable increase in the number of patients that can be served by each manufacturing plant, resulting in a decrease in cost of goods and increased margins for pharma. Overall, this translates into better healthcare at a lower cost.
To evaluate the toxicological effects of an inhaled drug or toxicant it is often desirable to delivery high concentrations of an aerosol in a short period of time. SUPRAER is a compact turn-key system that produces concentrated aerosols from solutions or sols of the test agent.
SUPRAER is a very compact spray dryer that is ideal for spray drying very small quantities of valuable materials. SUPRAER incorporates low shear jet-type nozzles. This facilitates scalability.