Patent ID: 8574595

Claim:
A method for purification of a recombinant adenovirus to prepare a recombinant adenovirus preparation for clinical use, said method consisting essentially of: a) culturing cells that are infected with said recombinant adenovirus, b) lysing said cells and removing or fragmenting free nucleic acid, to provide a lysate comprising the recombinant adenovirus, c) clarifying the lysate to obtain an adenovirus preparation, d) subjecting the adenovirus preparation to ultrafiltration, wherein the adenovirus preparation is in the retentate, to concentrate the adenovirus preparation to obtain a concentrated adenovirus preparation, e) subjecting the concentrated adenovirus preparation of step d) to ultrafiltration, wherein the adenovirus preparation is in the retentate, and exchanging it with at least 5 diafiltration volumes (DFVs) of buffer, wherein one DFV is the volume of the retentate after concentration in step d), and f) subjecting the adenovirus preparation of step e) to sterile filtration, to obtain the recombinant adenovirus preparation for clinical use; wherein in steps d) and e) back pressure of at least 5 kPa is applied on the permeate side, and wherein the method does not utilize a chromatography column and an ion exchange filter.