ANALYTICAL ANION-EXCHANGE HPLC OF RECOMBINANT TYPE-5 ADENOVIRAL PARTICLES

The expanding use of adenoviral vectors for gene therapy has brought a bout the need for new analytical tools, We have developed an anion-exc hange high-performance liquid chromatography method to analyze recombi nant adenovirus serotype 5 samples, Before this assay, available analy tical methods consisted of either longterm biological assays or requir ed highly purified test articles, These methods were inadequate for op timizing adenovirus production and purification, This assay can quanti tate viral particles in either crude lysates or highly pure samples. I t can be used to assess particles in both dilute and concentrated samp les over a wide dynamic range. Moreover, the population of viral parti cles eluted in the peak contains most of the infectious virions, This assay is a sensitive technique that overcomes the limitations of previ ous methods. It provides an essential tool to accomplish process optim ization.