IP Library › Granted Patent US 12,577,541
Granted Patent B2
US 12,577,541 · App. 17/034,168 · Granted Mar 17, 2026

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

Inventors: Yi Hong (Shanghai, CN); Ting Yan (Shanghai, CN); Jiangguo Ying (Shanghai, CN); Haojie Zhang (Shanghai, CN); Li Zhang (Shanghai, CN); Fei Wang (Shanghai, CN); Dijun Zhao (Shanghai, CN); Luyi Zhang (Shanghai, CN)
Assignee: ABELZETA INC.
C12N7/02C12M47/02C12M47/12C12N7/00C12N15/101C12N15/1017C12N15/86C12N2740/15021C12N2740/15043C12N2740/15051
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Quick Facts
Patent No.
US 12,577,541
App. No.
17/034,168
Granted
Mar 17, 2026
Kind
B2
Abstract

Provided is a method for large-scale preparation of a purified preparation of a recombinant lentiviral vector at the GMP grade. The method comprises: (a) providing raw material feed liquid to be purified that comprises recombinant viral vectors; (b) carrying out a microfiltration treatment on the feed liquid to obtain a microfiltered filtrate comprising the recombinant viral vectors; (c) optionally concentrating the filtrate to obtain a concentrated filtrate; (d) purifying the filtrate obtained in the previous step by means of chromatography to obtain a crude pure product comprising the recombinant viral vectors; and (e) subjecting the crude pure product obtained in the previous step to liquid exchange and elaborate purification to obtain the purified recombinant viral vectors.

Claims (20)

1 . 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.

2 . The method according to claim 1 , wherein the chromatography in step (d) comprises anion chromatography followed by multimodal composite chromatography.

3 . The method according to claim 1 , wherein in step (d), the purified recombinant viral vectors have one or more of the following features:

(p1) the biological titer of the recombinant viral vectors is 1.06×10 9 Tu/mL;

(p2) BSA residue<50 ng/mL;

(p3) endotoxin<1 EU/mL.

4 . A purification device for performing the method of claim 1 , wherein the purification device comprises:

a microfiltration unit, used for performing microfiltration treatment of the recombinant viral vectors to be purified, so as to obtain a microfiltered filtrate;

a concentration unit, used for concentrating the microfiltered filtrate, so as to obtain a concentrated filtrate; and

a chromatographic purification unit, used for purifying by chromatography the concentrated filtrate, so as to obtain purified recombinant viral vectors.

5 . The purification device according to claim 4 , wherein the chromatographic purification unit comprises a size exclusion chromatography unit and an anion chromatography unit.

6 . The purification device according to claim 4 , wherein the purification device further comprises:

a nuclease treatment unit, comprising an addition device for adding a nuclease.

7 . The method of claim 1 , wherein the recombinant viral vectors comprise lentiviral vectors.

Assignments (3)
CHANGE OF NAME Recorded Jan 17, 2024
From: CELLULAR BIOMEDICINE GROUP, INC.
To: ABELZETA INC.
Reel/Frame 066340/0795 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2022
From: CELLULAR BIOMEDICINE GROUP HK LTD.
To: CELLULAR BIOMEDICINE GROUP INC.
Reel/Frame 062175/0636 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 6, 2020
From: HONG, YI; YAN, TING; YING, JIANGGUO; ZHANG, HAOJIE; ZHANG, LI; WANG, FEI; ZHAO, DIJUN; ZHANG, LUYI
To: CELLULAR BIOMEDICINE GROUP HK LIMITED
Reel/Frame 053985/0733 →
Priority Claims (1)
CN 201810264813.X · Mar 28, 2018 · national
Continuity (2)
Continuation PCTCN2019080213 · Mar 28, 2019
Related Publication 20210147826A1 · May 20, 2021
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