Method for large-scale preparation of purified preparation of recombinant lentiviral vector at GMP grade

A method for large-scale purification of recombinant viral vectors, wherein the method comprises:

• (a) providing a feed liquid comprising the recombinant viral vectors, wherein the feed liquid has a volume of no less than 20 liters;
• (b) carrying out a microfiltration treatment on the feed liquid to obtain a microfiltered filtrate, which comprises the recombinant viral vectors, wherein the microfiltration treatment is conducted using a microfiltration hollow fiber column, wherein the microfiltration hollow fiber column comprises a microfiltration membrane with a cut-off value of 0.4 to 0.8 μm;
• (c) concentrating the filtrate to obtain a concentrated filtrate, wherein the concentrating is conducted using an ultrafiltration membrane with a cut-off value of 100 K to 800 K;
• (d) purifying the filtrate by chromatography to obtain a crude product comprising the recombinant viral vectors;
• and
• (e) subjecting the crude product to liquid exchange and purification to obtain purified recombinant viral vectors;
• wherein the chromatography in step (d) is selected from anion chromatography, size exclusion chromatography and multimodal composite chromatography, or combinations thereof.