The 2009 H1N1 pandemic illustrates a critical weakness in our ability to respond to a pandemic threat. The ability to ramp up production of vaccine doses within the critical period from the discovery of the threat is hindered by two major supply constrictions: 1) production technology for producing influenza vaccines in eggs; and 2) the logistical considerations involved in deploying and delivering a refrigerated parenteral vaccine by trained personnel. Our Ad 4 vaccine vector encoding influenza antigens and a delivered oral dosage form addresses both of these issues. This project focuses on developing a old technique to be applied in a new way to increase the speed and scale of producing live vaccine powder in both a convention form and in a coated form. That technique utilizes spray drying to replace lyophilization as a drying method. The program also consists of enteric coating of adenovirus technology that can be incorporated in a manufacturing process suitable for drying the vector. Spray drying is unique in that the coating and drying process are achieved simultaneously. The resulting enteric coated vector platform could be used for widely different vaccine applications, and would therefore save both time and money in development of vaccines against emerging diseases, bioterror threats, and pandemics.
Public Health Relevance: Spray Drying, a simple and versatile manufacturing process to make powder products in bulk for vaccines and biologics. Spray drying process for biologics allows meeting any emergency needs at low cost per dose through economies of scale. A Spray Drying process manufacturing site can be commissioned anywhere in the world in the event of an emergency situation.
Public Health Relevance Statement: Spray Drying, a simple and versatile manufacturing process to make powder products in bulk for vaccines and biologics. Spray drying process for biologics allows meeting any emergency needs at low cost per dose through economies of scale. A Spray Drying process manufacturing site can be commissioned anywhere in the world in the event of an emergency situation.
NIH Spending Category: Biotechnology; Emerging Infectious Diseases; Immunization; Infectious Diseases; Influenza; Pneumonia & Influenza; Prevention; Vaccine Related
Project Terms: Address; Adenoviruses; Adult; Antigens; Area; Attenuated Vaccines; base; Biological Models; cell bank; Cell Culture System; Childhood; constriction; cost; critical period; Cultured Cells; Cyclic GMP; design; Development; Disease; Dosage Forms; Dose; egg; Elderly; Emergency Situation; Enteral; Event; experience; falls; Freeze Drying; Generations; Goals; Human Resources; Industry; Influenza; Influenza A Virus, H1N1 Subtype; Influenza virus vaccine; Life; Liquid substance; manufacturing process; meetings; Methodology; Methods; Military Personnel; Molecular Biology Techniques; Oral; pandemic disease; Phase; Phase I Clinical Trials; Population; Powder dose form; Process; Production; programs; Ramp; Recombinants; Site; Small Business Innovation Research Grant; Solutions; Speed (motion); Suspension substance; Suspensions; Syringes; System; Techniques; Technology; Time; Training; vaccine candidate; vaccine development; Vaccine Production; Vaccines; vector; vector vaccine; Virus; Work
