Use of Spray-Drying as a Manufacturing Process for Oral Adenovirus Vaccine

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43GM101737-01
Agency Tracking Number: R43GM101737
Amount: $298,464.00
Phase: Phase I
Program: SBIR
Awards Year: 2012
Solicitation Year: 2012
Solicitation Topic Code: NIGMS
Solicitation Number: PA09-113
Small Business Information
3985A SORRENTO VALLEY BLVD, SAN DIEGO, CA, 92121
DUNS: 806518598
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 AMISH PATEL
 (858) 450-9595
 apatel@paxvax.com
Business Contact
 KENNETH KELLEY
Phone: (858) 450-9595
Email: banderson@paxvax.com
Research Institution
 Stub
Abstract
DESCRIPTION (provided by applicant): 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 vaccinevector 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 indevelopment 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.

* Information listed above is at the time of submission. *

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