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Principal Investigator: Maksim Mezhericher
Organization: INAEDIS, INC
Fiscal Year: 2024
Award: $312,634
Funding agency: National Center for Advancing Translational Sciences
Abstract
INAEDIS proposes to develop a platform technology for rapid room temperature dehydration of vaccines and
biopharmaceutical formulations using ultra-fine droplet aerosols, eliminating the need for logistically challenging
cold chain infrastructure. Some 20% of pharmaceuticals ‒ around $35B in value ‒ are estimated to be damaged
by poor temperature control during transport alone, and the challenges of maintaining cold chain during storage
and handling only add to wastage and reduced efficacy. Alarmingly, cold chain breach has been implicated in
cases of vaccine-preventable disease or even adverse events following immunization. For example, one study
reported adverse events suffered by 7% of patients administered with temperature compromised vaccines, 13%
of which were considered serious. Freeze-drying of biological formulations, which is traditional in the production
of pharmaceuticals, introduces time-consuming (1-3 days of processing), poorly scalable, energy inefficient, and
expensive batch manufacturing. Alternative spray drying methods have been explored, though this technique
remains inefficient (0.1-1 g of inhalable particulate product out of 1 kg of liquid formulation), energy intense and
poses risk of product thermal damage due to applied high drying temperatures (100-200 °C). To mitigate the
consequences of poor vaccine access and vaccine failure on population immunization, there is a clear need for
thermal stabilization of the formulations enabling robust vaccine transport and storage solutions. INAEDIS has
developed a method of Rapid Room Temperature Aerosol Dehydration (RTAD), a scalable system for
continuous dehydration of liquid pharmaceutical and biopharmaceutical formulations that provides thermal
stabilization of biological drugs and eliminates the need for a cold supply chain. INAEDIS’s process can generate
aerosols with droplets that are 100x smaller (0.2-10 μm) and yield 100x more inhalable particulate product (50-
300 g) from 1 kg of liquid than existing spray drying technologies, without applying heat for drying, which mitigates
the risk of damage of thermolabile biologicals and provides a significant reduction in energy requirements.
Preliminary studies conducted with a Top 10 Pharma company have demonstrated superiority of the system
over traditional spray dryers with respect to powder dissolution, protein aggregation, particle size and size
uniformity, and inhalability of biologic formulation. Internal studies have also exhibited a 5-10x improvement in
bacteriophage survival rate. For this Phase I, INAEDIS seeks to establish the efficacy, reliability, and applicability
of RTAD. Specific aims include: 1) Demonstrate platform capabilities of the laboratory-scale RTAD process for
three major classes of bioformulations, 2) Demonstrate powder performance and shelf-life stability of produced
dehydrated formulations, and 3) Improve yield and scale up processes to establish commercial viability of the
current laboratory scale, and ramp up production capacity to a pilot scale. This will position INAEDIS for Phase
II, during which the platform will be adapted and validated on a broader spectrum of commercially relevant
biopharmaceuticals and further scaled up to meet the needs of pilot customers in the pharmaceutical industry.
Terms: <Acute><Adverse Experience><Adverse event><Aerosols><Affect><Bacteriophages><Biological><Biological Agent><Biological Products><Cessation of life><Clinical Treatment Moab><Cold Chains><Consumption><Dangerousness><Death><Dehydration><Department of Health and Human Services><Development><Diameter><Disease><Disease Outbreaks><Disorder><Drug Industry><Drugs><Dryness><Event><Exhibits><Exposure to><Fainting><Formulation><Freeze Drying><Freeze Dryings><Freezing><Glass><Hour><Immunization><Infrastructure><Laboratories><Life><Liquid substance><Lyophilization><Measles><Medication><Medicine><Methods><Monoclonal Antibodies><Morphology><Nebulizer><Neurologic><Neurological><Outbreaks><PM2.5><Particle Size><Particulate><Patients><Performance><Phages><Pharmaceutic Industry><Pharmaceutical Agent><Pharmaceutical Industry><Pharmaceutical Preparations><Pharmaceuticals><Pharmacologic Substance><Pharmacological Substance><Phase><Play><Population><Position><Positioning Attribute><Powder dose form><Powders><Process><Production><Property><Proteins><Provider><Ramp><Reporting><Research><Residual><Residual state><Retrospective Studies><Risk><Rubeola><Sampling><Shoulder><Stress><Structure><Survival Rate><Syncope><System><Techniques><Technology><Temperature><Time><Transition Temperature><Ultrafine><Ultrasonic><Ultrasonics><United States Department of Health and Human Services><United States Dept. of Health and Human Services><Vaccines><Virus><Waste Products><World Health Organization><access to vaccination><access to vaccines><adverse consequence><adverse outcome><analog><bacterial virus><biologic><biologics><biopharmaceutical><biotherapeutic agent><body water dehydration><cost><crystallinity><developmental><diagnostic tool><drug safety><drug/agent><energy efficiency><fine particles><fine particulate matter><fluid><improved><indexing><innovate><innovation><innovative><insoluble aggregate><lipid based nanoparticle><lipid nanoparticle><liquid><liquid formulation><mAbs><manufacture><medication safety><meter><monoclonal Abs><morbilli><nebulization><nebulize><particle><pharmaceutical><pharmaceutical safety><process improvement><protein aggregate><protein aggregation><rapid method><rapid technique><reconstitute><reconstitution><respiratory><risk mitigation><scale up><small molecule><study characteristics><success><supply chain><technology platform><technology system><vaccination access><vaccination availability><vaccine access><vaccine availability><vaccine failure><wasting>