Production and Quality Control of Adenoviral Vectors for Clinical Trials

ABSTRACT

The importance of recombinant adenoviral vectors for the development of gene therapy and prophylactic and therapeutic vaccines has led to efforts for process development of large scale production of clinically safe adenoviral vectors. First of all, cell lines producing replication incompetent adenoviral vectors required for clinical application have been developed and the concept of banking and characterization of cell lines and adenoviral vectors has been established. In order to meet the need of amount of adenoviral vectors for clinical trials, various large scale suspension culture methods using serum-free media have been developed along with development of large scale purification methods using chromatography instead of cesium chloride method. In addition, methods for the quality control of adenoviral vectors have been established and applied for the clinical lots.