1. WO2026174456 - METHOD FOR PURIFYING RECOMBINANT ADENO-ASSOCIATED VIRUS

Publication Number WO/2026/174456

Publication Date 27.08.2026

International Application No. PCT/CN2025/078046

International Filing Date 19.02.2025

IPC

C12N 7/02 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
7	Viruses, e.g. bacteriophages; Compositions thereof; Preparation or purification thereof
02	Recovery or purification

C12N 15/86 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15	Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09	Recombinant DNA-technology
63	Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
79	Vectors or expression systems specially adapted for eukaryotic hosts
85	for animal cells
86	Viral vectors

B01D 15/16 2006.1

B	PERFORMING OPERATIONS; TRANSPORTING
01	PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
D	SEPARATION
15	Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
08	Selective adsorption, e.g. chromatography
10	characterised by constructional or operational features
16	relating to the conditioning of the fluid carrier

B01D 15/36 2006.1

B	PERFORMING OPERATIONS; TRANSPORTING
01	PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
D	SEPARATION
15	Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
08	Selective adsorption, e.g. chromatography
26	characterised by the separation mechanism
36	involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion

A61K 48/00 2006.1

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
48	Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy

A61K 35/761 2015.1

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
35	Medicinal preparations containing materials or reaction products thereof with undetermined constitution
66	Microorganisms or materials therefrom
76	Viruses; Subviral particles; Bacteriophages
761	Adenovirus

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C12N 7/02 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
7	Viruses, e.g. bacteriophages; Compositions thereof; Preparation or purification thereof
02	Recovery or purification

C12N 15/86 2006.1

C	CHEMISTRY; METALLURGY
12	BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N	MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
15	Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
09	Recombinant DNA-technology
63	Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
79	Vectors or expression systems specially adapted for eukaryotic hosts
85	for animal cells
86	Viral vectors

B01D 15/16 2006.1

B	PERFORMING OPERATIONS; TRANSPORTING
01	PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
D	SEPARATION
15	Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
08	Selective adsorption, e.g. chromatography
10	characterised by constructional or operational features
16	relating to the conditioning of the fluid carrier

B01D 15/36 2006.1

B	PERFORMING OPERATIONS; TRANSPORTING
01	PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
D	SEPARATION
15	Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
08	Selective adsorption, e.g. chromatography
26	characterised by the separation mechanism
36	involving ionic interaction, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion

A61K 48/00 2006.1

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
48	Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy

A61K 35/761 2015.1

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
35	Medicinal preparations containing materials or reaction products thereof with undetermined constitution
66	Microorganisms or materials therefrom
76	Viruses; Subviral particles; Bacteriophages
761	Adenovirus

A61P 27/00 2006.1

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
P	SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
27	Drugs for disorders of the senses

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Applicants

• 成都金唯科生物科技有限公司 CHENGDU GENEVECTOR BIOTECHNOLOGY CO., LTD. [CN]/[CN]

Inventors

• 杨阳 YANG, Yang
• 王伟 WANG, Wei
• 吴小艳 WU, Xiaoyan

Agents

• 成都七星天知识产权代理有限公司 METIS IP (CHENGDU) LLC

Priority Data

Publication Language Chinese (zh)

Filing Language Chinese (zh)

Designated States

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AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CV, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, MG, MK, MN, MU, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UY, UZ, VC, VN, WS, ZA, ZM, ZW
African Regional Intellectual Property Organization (ARIPO) (BW, CV, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SC, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, ME, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)

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Title

(EN) METHOD FOR PURIFYING RECOMBINANT ADENO-ASSOCIATED VIRUS

(FR) PROCÉDÉ DE PURIFICATION D'UN VIRUS ADÉNO-ASSOCIÉ RECOMBINANT

(ZH) 一种纯化重组腺相关病毒的方法

Abstract

(EN) Provided in one or more embodiments of the present description are a method for purifying a recombinant adeno-associated virus, a recombinant adeno-associated virus prepared according to the method, and the use thereof in a gene therapy product. The method comprises: performing a first anion exchange chromatography step on an initial recombinant adeno-associated virus sample to obtain a first eluted sample, the initial recombinant adeno-associated virus sample being obtained by processing a recombinant adeno-associated virus feed solution; and performing a second anion exchange chromatography step on the first eluted sample to obtain a purified recombinant adeno-associated virus, the purified recombinant adeno-associated virus having a total yield of greater than 70% and an empty capsid ratio of less than or equal to 20%.

(FR) Un ou plusieurs modes de réalisation de la présente description concernent un procédé de purification d'un virus adéno-associé recombinant, un virus adéno-associé recombinant préparé selon le procédé, et son utilisation dans un produit de thérapie génique. Le procédé comprend : la réalisation d'une première étape de chromatographie d'échange d'anions sur un échantillon initial de virus adéno-associé recombinant afin d'obtenir un premier échantillon élué, ledit échantillon initial de virus adéno-associé recombinant étant obtenu par traitement d'une solution d'alimentation de virus adéno-associé recombinant ; et la réalisation d’une deuxième étape de chromatographie d’échange d’anions sur le premier échantillon élué afin d’obtenir un virus adéno-associé recombinant purifié, ledit virus adéno-associé recombinant purifié présentant un rendement total supérieur à 70 % et un taux de capsides vides inférieur ou égal à 20 %.

(ZH) 本说明书一个或多个实施例提供一种纯化重组腺相关病毒的方法以及根据该方法制备的重组腺相关病毒及其在基因治疗产品的应用。所述方法包括对初始重组腺相关病毒样品进行第一步阴离子交换层析，得到第一洗脱样品，其中，所述初始重组腺相关病毒样品通过对重组腺相关病毒料液进行处理得到；以及对所述第一洗脱样品进行第二步阴离子交换层析，得到纯化后的重组腺相关病毒，所述纯化后的重组腺相关病毒的总收率大于70％以及空壳率小于或等于20％。

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