Open AccessMaking the (clinical) grade with adenoviral gene therapy vectors
Author(s) -
Hutchins Beth
Publication year - 1997
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/(sici)1099-1786(199709)2:3<119::aid-qaj44>3.0.co;2-t
Subject(s) - quality assurance , good manufacturing practice , genetic enhancement , certification , clinical trial , viral vector , medicine , virology , engineering , gene , biology , pathology , operations management , regulatory affairs , biochemistry , external quality assessment , political science , law , recombinant dna
Abstract Engineered adenoviruses offer an attractive means by which gene therapy might be achieved. The first level of assurance that patients will not be put at unnecessary risk during clinical trials, are clinical lots of adenoviruses produced from cell and virus banks demonstrated to be free from adventitious agents. Similarly tested media components and equipment, and facilities that are monitored and certified, offer an additional safety measure. Characterisation and release testing of purified adenoviral bulks and product vials offer a final level of assurance for the integrity and quality of the clinical material; a check in the overall system of manufacturing adenoviral vectors under Good Manufacturing Practices. © 1997 John Wiley & Sons, Ltd.