IP Library Granted Patent US 12,365,870
Granted Patent B2
US 12,365,870 · App. 17/504,067 · Granted Jul 22, 2025

Storage stabilizer for extracellular vesicle and storage stabilization method for extracellular vesicle

Inventors: Masayuki Yamane (Amagasaki, JP); Naoko Imawaka (Amagasaki, JP); Yuji Nakagawa (Osaka, JP); Kodai Sasamoto (Amagasaki, JP)
Assignee: FUJIFILM Corporation
C12N5/00C08F126/10
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Quick Facts
Patent No.
US 12,365,870
App. No.
17/504,067
Granted
Jul 22, 2025
Kind
B2
Abstract

An object of the present invention is to provide a means capable of stably storing an extracellular vesicle. The present invention relates to a storage stabilizer for an extracellular vesicle, which contains a copolymer containing a monomer unit derived from vinylpyrrolidone and a monomer unit derived from vinyl acetate, or a polymer having a monomer unit derived from vinylpyrrolidone such as polyvinylpyrrolidone and relates to a storage stabilization method for an extracellular vesicle, which includes cryopreserving an extracellular vesicle in the presence of the polymer.

Claims (12)

1. A storage stabilization method for an extracellular vesicle, comprising cryopreserving an extracellular vesicle in a presence of a polymer having a monomer unit derived from vinylpyrrolidone,

wherein the polymer is a copolymer containing a monomer unit derived from vinylpyrrolidone and a monomer unit derived from vinyl acetate, or polyvinylpyrrolidone having a weight-average molecular weight of 1,500 to 15,000;

the cryopreserving of an extracellular vesicle is cryopreserving a storage solution comprising the polymer, the extracellular vesicle, and an aqueous solution; and

the concentration of the polymer in the storage solution is 0.001 to 1% (w/v).

2. The storage stabilization method for an extracellular vesicle according to claim 1 , wherein the polymer is a copolymer containing a monomer unit derived from vinylpyrrolidone and a monomer unit derived from vinyl acetate.

3. The storage stabilization method for an extracellular vesicle according to claim 2 , wherein a constitution ratio of the monomer unit derived from vinylpyrrolidone to the monomer unit derived from vinyl acetate in the copolymer is 1:0.1 to 1:3.

4. The storage stabilization method for an extracellular vesicle according to claim 2 , wherein a Fikentscher K value of the copolymer is 5 to 50.

5. The storage stabilization method for an extracellular vesicle according to claim 2 , wherein a weight-average molecular weight of the copolymer is 3,000 to 250,000.

6. The storage stabilization method for an extracellular vesicle according to claim 1 , wherein the polymer is polyvinylpyrrolidone.

7. The storage stabilization method for an extracellular vesicle according to claim 6 , wherein a Fikentscher K value of the polyvinylpyrrolidone is 9 to 20.

8. The storage stabilization method for an extracellular vesicle according to claim 1 , wherein the extracellular vesicle is an isolated extracellular vesicle.

9. The storage stabilization method for an extracellular vesicle according to claim 1 , which further comprises isolating an extracellular vesicle from a biological specimen prior to cryopreserving the extracellular vesicle.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 6, 2026
From: FUJIFILM CORPORATION
To: FUJIFILM WAKO PURE CHEMICAL CORPORATION
Reel/Frame 073999/0664 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 30, 2022
From: FUJIFILM WAKO PURE CHEMICAL CORPORATION
To: FUJIFILM CORPORATION
Reel/Frame 060939/0900 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 19, 2021
From: YAMANE, MASAYUKI; IMAWAKA, NAOKO; NAKAGAWA, YUJI; SASAMOTO, KODAI
To: FUJIFILM WAKO PURE CHEMICAL CORPORATION
Reel/Frame 057836/0957 →
Priority Claims (1)
JP 2019-080005 · Apr 19, 2019 · national
Continuity (2)
Continuation PCTJP2020016738 · Apr 16, 2020
Related Publication 20220033765A1 · Feb 3, 2022
References Cited (40)
US 5178884A · Goodrich · 1993 [cited by examiner]
US 5876754A · Wunderlich · 1999 [cited by examiner]
US 20030215515A1 · Truong-Le et al. · 2003 [cited by applicant]
US 20060127375A1 · Livesey · 2006 [cited by examiner]
US 20090155331A1 · Ruddy · 2009 [cited by examiner]
US 20120252795A1 · Nguyen · 2012 [cited by examiner]
US 20150125864A1 · Kang et al. · 2015 [cited by applicant]
US 20190275159A1 · Soane et al. · 2019 [cited by applicant]
US 20230247982A1 · Joseph · 2023 [cited by examiner]
CN 101287449A · 2008 [cited by applicant]
CN 104208677A · 2014 [cited by applicant]
CN 109355258A · 2019 [cited by applicant]
EP 2253306A1 · 2010 [cited by examiner]
JP 2006512102A · 2006 [cited by applicant]
JP 2018130085A · 2018 [cited by applicant]
KR 1020100112206A · 2010 [cited by applicant]
WO 03087335A2 · 2003 [cited by applicant]
WO 2018070939A1 · 2018 [cited by applicant]
WO 2020257710A1 · 2020 [cited by applicant]
Alberro, A.; Iparraguirre, L.; Fernandes, A.; Otaegui, D. Int. J. Mol. Sci. 2021, 22, 8163. (Year: 2021). [cited by examiner]
Ashland Product Grades (Year: 2020). [cited by examiner]
Extended European Search Report dated Dec. 23, 2022 in European patent application No. 20792189.1. [cited by applicant]
Chi-Gu Kim et al., “Effect of the Polyvinylpyrrolidone Concentration of Cryoprotectant on Mouse Embryo Development and Production of Pups: 7.5% of PVP is Beneficial for In Vitro and In Vivo Development of Frozen-Thawed … [cited by applicant]
S.S. Ray et al., “Serum-free non-toxic freezing solution for cryopreservation of human adipose tissue-derived mesenchymal stem cells”, Biotechnol Lett, 2016, vol. 38 No. 8, pp. 1397-1404 (8 pages total). [cited by applicant]
International Search Report issued Jul. 14, 2020 in International Application No. PCT/JP2020/016738. [cited by applicant]
Written Opinion of the International Searching Authority issued Jul. 14, 2020 in International Application No. PCT/JP2020/016738. [cited by applicant]
International Preliminary Report on Patentability issued Sep. 28, 2021 in International Application No. PCT/JP2020/016738. [cited by applicant]
Thirumala et al., “Evaluation of Polyvinylpyrrolidone as a Cryoprotectant for Adipose Tissue-Derived Adult Stem Cells”, Tissue Engineering: Part C, 2010, vol. 16, No. 4, pp. 783-792 (10 pages total). [cited by applicant]
Fuhrmann et al., “Stability of extracellular vesicles during lyophilization—implications for their pharmaceutical use”, Journal of Extracellular Vesicles, 2016, vol. 5, No. 30924, p. 14, Poster 27 (2 pages total). [cited by applicant]
Ahmed et al., “Formulation and clinical investigation of optimized vinopocetine lyoplant-tabs: new strategy in development of buccal solid dosage form”, Drug Design, Development and Therapy, 2019, vol. 13, pp. 205-220 (… [cited by applicant]
Souzu, “Mechanism of defect and protection by freezing of living cells”, Kagaku To Seibutsu, 1980, vol. 18, No. 2, pp. 78-87 (10 pages total). [cited by applicant]
Dai-Ichi Kogyo Seiyaku Shaho, “Water soluble polymers in aqueous solution, Unique water-soluble polymer, polyvinylpyrrolidone”, 2016, No. 576, p. 17 (1 page total). [cited by applicant]
Bosch et al., “Trehalose prevents aggregation of exosomes and cryodamage”, Scientific Reports, vol. 6, No. 36162, pp. 1-11 (2016)(11 pages total). [cited by applicant]
Office Action issued May 23, 2023 in Japanese Application No. 2021-514217. [cited by applicant]
Office Action issued Mar. 10, 2023 in Australian Application No. 2020259891. [cited by applicant]
Communication dated Dec. 16, 2023 issued by the State Intellectual Property Office of the P.R.China in Chinese application No. 202080029711.5. [cited by applicant]
Communication dated Nov. 3, 2023 issued by the Taiwanese Patent Office in Taiwanese application No. 109113011. [cited by applicant]
Volker Bühler, “Kollidon®: Polyvinylpyrrolidone excipients for the pharmaceutical industry”, 9th revised edition, Mar. 2008, pp. 4-330 (331 pages total), https://www.pharmacompass.com/pAssets/pdf/edgm/application/gmp-ko… [cited by applicant]
Office Action issued Jul. 14, 2023 in Chinese Application No. 202080029711.5. [cited by applicant]
Office Action issued May 22, 2024 in Korean Application No. 10-2021-7035069. [cited by applicant]