316. Production of Adenoviral Vectors in an Academic cGMP Facility

Abstract

Vectors used for early-phase clinical trials (Phase I-II) are required to be manufactured in a facility that at a minimum complies with cGMP (current good manufacturing practices) requirements on premises and equipment. Such facilities are mostly prevalent in academic institutions that provide support to in-house researchers as they embark on clinical testing of their vectors in humans. There are several advantages to establishment of an in-house facility for producing these vectors, such as increased accessibility to information or documentation essential for clinical trial applications. Disadvantages include the high costs associated with compliance to regulatory requirements with respect to establishment of facility, equipment, raw materials and training of personnel.