Title:
METHOD FOR CRYOPRESERVING BLOOD COAGULATION FACTOR VIII INTERMEDIATE PRODUCT
Document Type and Number:
WIPO Patent Application WO/2021/134180
Kind Code:
A1
Abstract:
The present invention relates to the field of blood products, and disclosed is a method for cryopreserving a blood coagulation factor VIII (FVIII) intermediate product. The blood coagulation FVIII intermediate product is taken from an FVIII concentrated solution or an FVIII chromatographic eluent before stock solution preparation or before ultrafiltration concentration or after ultrafiltration concentration in a preparation process of a blood coagulation FVIII preparation, and a combination or transformation thereof. Further disclosed in the present invention are use of the cryopreservation method in preparation of the blood coagulation FVIII preparation, reduction of impurity precipitation of a blood coagulation FVIII product, and improvement of long-term stability of the blood coagulation FVIII product, etc. The FVIII intermediate product is cryopreserved by means of the method of the present invention, so that it is ensured that the activity of FVIII is maintained or even improved, and the FVIII intermediate product can be prepared to a final product satisfying Chinese pharmacopoeia requirements by means of subsequent processes. The method for cryopreserving the blood coagulation FVIII intermediate product disclosed in the present invention improves the flexibility of an FVIII production process, and is favorable for productivity expansion and large-scale production of FVIII preparations.
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Inventors:
RAN SHUGUANG (CN)
WANG QIANG (CN)
JIANG DEXI (CN)
WANG QIANG (CN)
JIANG DEXI (CN)
Application Number:
PCT/CN2019/129854
Publication Date:
July 08, 2021
Filing Date:
December 30, 2019
Export Citation:
Assignee:
SICHUAN YUANDA SHUYANG PHARMACEUTICAL CO LTD (CN)
International Classes:
C07K14/755; C07K1/14; C07K1/34; C07K1/36
Domestic Patent References:
| WO2015143696A1 | 2015-10-01 |
Foreign References:
| CN105348382A | 2016-02-24 | |||
| CN105294858A | 2016-02-03 | |||
| CN108976297A | 2018-12-11 | |||
| CN107337727A | 2017-11-10 | |||
| CN104231073A | 2014-12-24 | |||
| CN105348382A | 2016-02-24 | |||
| CN105294858A | 2016-02-03 | |||
| CN108976297A | 2018-12-11 | |||
| CN107337727A | 2017-11-10 | |||
| CN104231073A | 2014-12-24 |
Attorney, Agent or Firm:
WAYNE INTELLECTUAL PROPERTY AGENCY CO., LTD. (CN)
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