CN1194005C - 利用Sepharose4FF柱层析技术生产流行性感冒灭活疫苗 - Google Patents
利用Sepharose4FF柱层析技术生产流行性感冒灭活疫苗 Download PDFInfo
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- CN1194005C CN1194005C CN 00109399 CN00109399A CN1194005C CN 1194005 C CN1194005 C CN 1194005C CN 00109399 CN00109399 CN 00109399 CN 00109399 A CN00109399 A CN 00109399A CN 1194005 C CN1194005 C CN 1194005C
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- 238000004440 column chromatography Methods 0.000 title claims abstract description 12
- 206010022000 influenza Diseases 0.000 title claims abstract description 9
- 229960005486 vaccine Drugs 0.000 title claims 2
- 229920002684 Sepharose Polymers 0.000 title abstract description 14
- 238000000034 method Methods 0.000 claims abstract description 9
- 229940031551 inactivated vaccine Drugs 0.000 claims abstract description 8
- 238000004519 manufacturing process Methods 0.000 claims abstract description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 6
- 239000011780 sodium chloride Substances 0.000 claims description 3
- 238000000108 ultra-filtration Methods 0.000 claims description 3
- 210000003837 chick embryo Anatomy 0.000 claims description 2
- 238000004587 chromatography analysis Methods 0.000 claims description 2
- 239000012528 membrane Substances 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 claims description 2
- 241000712461 unidentified influenza virus Species 0.000 claims description 2
- 210000001643 allantois Anatomy 0.000 claims 1
- 210000004379 membrane Anatomy 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract description 6
- 229930006000 Sucrose Natural products 0.000 abstract description 6
- 238000005119 centrifugation Methods 0.000 abstract description 5
- 239000005720 sucrose Substances 0.000 abstract description 4
- 230000005847 immunogenicity Effects 0.000 abstract description 2
- 241000700605 Viruses Species 0.000 abstract 1
- 230000007547 defect Effects 0.000 abstract 1
- 229960004793 sucrose Drugs 0.000 description 3
- 238000011161 development Methods 0.000 description 2
- 235000013681 dietary sucrose Nutrition 0.000 description 2
- 230000003067 hemagglutinative effect Effects 0.000 description 2
- 230000003616 anti-epidemic effect Effects 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 108700010900 influenza virus proteins Proteins 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
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- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Abstract
目前国内外流感灭活疫苗的生产工艺基本上均为蔗糖梯度密度离心技术，利用Seogarise 4FF柱层析技术生产流感灭活疫苗在国内外文献中均尚未见报道。蔗糖梯度密度离心技术设备昂贵，操作繁琐，而Seogarise 4FF柱层析技术则刚好相反。目前已有许多人利用Sepharose 4FF柱层析技术进行病毒的纯化工作。现已证明，利用Sepharose 4FF柱层析技术生产的流感灭活疫苗具有很好的安全性和较好的免疫原性。
Description
技术领域：
本发明属于生物学领域，具体地说，本发明涉及一种利用Sepharose4FF柱层析技术生产流行感冒灭活疫苗的工艺。
背景技术：
目前，国内外生产的流感灭活疫苗均采用蔗糖梯度密度离心技术工艺，而利用
Sepharose 4FF柱层析技术生产流感灭活疫苗在国内外文献中均尚未见报道；蔗糖梯度密度离心技术设备昂贵，操作繁琐，而Sepharose 4FF柱层析技术则刚好相反。本发明专利采用Sepharose 4FF柱层析技术代替蔗糖梯度密度离心技术，既可降低流感灭活疫苗的生产成本，又可确保该制品安全有效。
发明内容
Sepharose 4FF：专业术语，系瑞典Pharmacia公Sepharose 4FF司生产的凝胶型号，全称是Sepharose 4Fast Flow，简称：Sepharose 4FF凝胶。
常规方法制备的流感病毒鸡胚尿囊液收获后，利用10万分子量超滤膜对其进行超滤浓缩，并利用pH7.6 0.01mol/L PBS(0.14mol/L NaCl)平衡后，按不高于层析柱凝胶体积的5％进行上样，用pH7.6 0.01mol/L PBS(0.14mol/LNaCl)进行洗脱，收获第I峰样品即为流感病毒蛋白。
具体实施方式：利用Sepharose 4FF柱层析技术生产的三批流感灭活疫苗：
1.放置37℃7天其血凝效价基本不下降，2-8℃12个月其血凝效价相对比较稳定。(稳定性试验原始资料均保存在我公司)。
2.经中国药品生物制品检定所检定，各项检定结果均符合本公司根据世界卫生组织《流行性感冒灭活疫苗》(WHO TRS No.814)规程拟定的《流行性感冒灭活疫苗制造及检定试行规程》的质量标准。
3.根据国家药品监督管理局(1999)制申体字第43号新药临床研究批件的要求，由中国药品生物制品检定所负责，会同黑龙江省卫生防疫站及黑龙江省林甸县卫生防疫站，共同对我公司研制的其中一批流感灭活疫苗进行了I、II期临床研究。结果表明我公司研制的流感灭活疫苗具有很好的安全性和较好的免疫原性(摘自中国药品生物制品检定所临床研究报告)。
Claims (1)
1、一种利用sepharose4FF柱层析技术生产流行感冒灭活疫苗的工艺，包括以下步骤：
将常规方法制备的流感病毒鸡胚尿囊收获后，利用10万分子量滤膜对其进行超滤浓缩，用pH7.6 0.01mol/L PBS、0.14mol/L NaCl平衡后，按不高于层析柱凝胶体积的5％进行上样，用pH7.6 0.01mol/LPBS、0.14mol/L NaCl进行洗脱，收获的1峰产物，即得本发明疫苗。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00109399 CN1194005C (zh) | 2000-06-01 | 2000-06-01 | 利用Sepharose4FF柱层析技术生产流行性感冒灭活疫苗 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 00109399 CN1194005C (zh) | 2000-06-01 | 2000-06-01 | 利用Sepharose4FF柱层析技术生产流行性感冒灭活疫苗 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1326939A CN1326939A (zh) | 2001-12-19 |
| CN1194005C true CN1194005C (zh) | 2005-03-23 |
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| CN 00109399 Expired - Lifetime CN1194005C (zh) | 2000-06-01 | 2000-06-01 | 利用Sepharose4FF柱层析技术生产流行性感冒灭活疫苗 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100540662C (zh) * | 2006-12-06 | 2009-09-16 | 云南沃森生物技术有限公司 | 一种混合床凝胶过滤层析技术用于病毒性疫苗纯化的方法 |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101627113B (zh) * | 2006-09-15 | 2013-04-24 | 米迪缪尼有限公司 | 支持病毒生长到高效价的mdck细胞系和采用该细胞系的生物反应器方法 |
| SG194372A1 (en) | 2008-09-24 | 2013-11-29 | Medimmune Llc | Methods for cultivating cells, propagating and purifying viruses |
| CN101602805B (zh) * | 2009-07-08 | 2012-11-21 | 中国科学院过程工程研究所 | 用于纯化手足口病免疫球蛋白的琼脂糖亲和介质及其制备方法 |
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2000
- 2000-06-01 CN CN 00109399 patent/CN1194005C/zh not_active Expired - Lifetime
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100540662C (zh) * | 2006-12-06 | 2009-09-16 | 云南沃森生物技术有限公司 | 一种混合床凝胶过滤层析技术用于病毒性疫苗纯化的方法 |
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| Publication number | Publication date |
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| CN1326939A (zh) | 2001-12-19 |
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Address after: 130103 Jilin province Changchun high tech Zone more Road No. 1615 Patentee after: Changchun Changsheng Life Sciences Limited Address before: 130012 Torch Road 1, hi tech Development Zone, Jilin, Changchun Patentee before: Changchun Changsheng Life Sciences Limited |
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Granted publication date: 20050323 |