Efficient Impurity Removal Using A Diafiltration Process

A method for purifying a viral vector from a solution comprising the viral vector and host cell proteins (HCP), the method comprising:

• a) circulating the solution across an ultrafiltration/diafiltration membrane using tangential flow filtration (TFF) mode at a loading of between 5 and 100 liters of bioreactor harvest per square meter of surface area of the ultrafiltration/diafiltration membrane and under a pulsatile flow having a frequency of 1.66 to 50 Hz and an amplitude of 2% to 25%, with a continuous addition of diafiltration buffer;
• b) filtering the solution across the ultrafiltration/diafiltration membrane to provide a permeate and a retentate, a volume of the retentate being kept constant by the continuous addition of diafiltration buffer, the viral vector being retained in the retentate and the HCP being filtered out via the permeate, a reduction of the HCP from the solution being between 1.5 and 4.3 log;
• and
• c) collecting the retentate, such that a purified viral vector solution is obtained.