从纯化到制剂——重组蛋白疫苗下游工艺与质量控制
2026-07-06 · 产品方案 · 百灵威授权转载
重组蛋白疫苗的下游工艺承担着从复杂细胞培养收获液中分离、纯化目标抗原的关键任务，直接决定疫苗产品的纯度、活性与安全性。一个完整的下游工艺通常包括细胞裂解与澄清、目标蛋白捕获与纯化、制剂与佐剂配制以及最终的质量控制。其中，细胞裂解与核酸去除（DNase I）是释放目标蛋白的第一步；亲和层析和离子交换层析等纯化介质则实现目标蛋白的高效捕获与杂质去除；制剂与佐剂环节涉及稳定剂、佐剂和表面活性剂的合理配比。最终，通过蛋白定量、电泳、HPLC、ELISA等多种检测手段对产品的纯度、浓度和活性进行放行检验。疫苗生产对原料的纯度和批次间一致性有着严格要求，高质量的工艺原料是保障疫苗安全有效的基础。
百灵威提供重组蛋白疫苗下游工艺与质量控制相关产品，涵盖蛋白纯化介质、蛋白表达与收获试剂、制剂与佐剂原料、蛋白定量与检测试剂以及分析色谱柱等，助力相关研究。
蛋白表达与收获
| 品名 | CAS | 货号 |
|---|---|---|
| Triton X-100, 98%, for molecular biology 曲拉通 X-100 | 9002-93-1 | 993361 |
| Sodium deoxycholate, 98% 去氧胆酸钠 | 302-95-4 | 559522 |
| Lysozymum 溶菌酶 | 9001-63-2 | FZ-0164378 |
| Recombinant UltraNuclease 重组全能核酸酶 | 9025-65-4 | K23893 |
| Deoxyribonuclease I, from bovine pancreas, ≥2000 Kunitz U/mg 脱氧核糖核酸酶 I | 9003-98-9 | 231871 |
蛋白纯化
| 品名 | CAS | 货号 |
|---|---|---|
| SERVA Ni-NTA Agarose Resin | / | 4213901 |
| SERVA Ni-IDA HD Agarose Resin | / | 4214102 |
| Beads IDA-Nickel, 10%(v/v), 30-150μm His-tag蛋白纯化磁珠（IDA-Ni) | / | 9298207 |
| His-tag蛋白纯化试剂盒（IDA-Co) His-tag蛋白纯化试剂盒（IDA-Co) | / | 70502-K10 |
| Beads IDA-Cobalt, 10%(v/v), 30-150μm His-tag蛋白纯化磁珠（IDA-Co) | / | 9298292 |
| Glutathione beads 4FF, Loading Capacity: almost 10 mg glutathione 高流速GST填料 | / | 1880140 |
| Protein G magnetic beads, 30 mg/mL, particle size: 1μm, magnet contents：35%-45%, surface potential：-26mV, SPG loading amount：70-85μg/mg 蛋白G磁珠 | / | 9251127 |
| rProtein G beads 4FF, Loading Capacity: > 30 mg human IgG 高流速蛋白G填料 | / | 1876789 |
| Protein A/G magnetic beads, 30 mg/mL, particle size: 1μm, magnet contents：35%-45%, surface potential：-26mV, SPA/G loading amount：70-85μg/mg 蛋白A/G磁珠 | / | 9251128 |
| Beads GSH, 10%(v/v), 30-150μm GST融合蛋白纯化磁珠 | / | 9298208 |
| Glutathione beads 4FF, Loading Capacity: almost 10 mg glutathione 高流速GST填料 | / | 1880140 |
| Beads MagroseStrep-Tactin, 10%(v/v), 30-150μm Strep-tagⅡ蛋白纯化磁珠 | / | 9298210 |
| Glutathione beads 4FF, Loading Capacity: almost 10 mg glutathione 高流速GST填料 | / | 1880140 |
| Q-Sepharose Fast Flow Q-琼脂糖凝胶FF | / | Q875246 |
| Dowex 1x8, 200 - 400 mesh, ion-exchange resin 离子交换树脂 | 12627-85-9 | 281941 |
| Amberlyst® A21, free base, particle size: 630 - 830 μm 安伯莱特离子交换树脂 A21 | 9049-93-8 | 909297 |
| Amberlite IRA-900, Cl form, ion-exchange resin 安伯莱特离子交换树脂 IRA-900 | 9050-97-9 | 259114 |
| Ambersep|r HPR900 OH, ion exchange resin, ambersep® HPR900 OH 离子交换树脂 | 9017-79-2 | 147150 |
| SP beads 6FF, Loading Capacity: 0.18 - 0.25 mmol H+,pH 2-12 强阳离子交换树脂 | / | 1876808 |
| Dowex® 50WX8 hydrogen form, 200-400 mesh Dowex® 50WX8氢型 | 11119-67-8 | 994037 |
| Amberlite IR120, H form, ion-exchange resin 安伯莱特离子交换树脂 IR120 | 78922-04-0 | 222221 |
| Dowex 50WX4, 200 - 400 mesh, H form, ion-exchange resin Dowex 离子交换树脂 | 11113-61-4 | 168245 |
| Dowex® 50WX8 hydrogen form, 100 - 200 mesh Dowex® 50WX8氢型 | 11119-67-8 | 982751 |
| CG-50-type 1, ion-exchange resin 离子交换树脂 CG-50(1型) | 9042-11-9 | 120866 |
| Amberlyst 15, (dry) ion-exchange resin 安伯莱特离子交换树脂 15 | 9037-24-5 | 349700 |
| Butyl beads 4FF, Loading Capacity: 7 mg IgG, 26 mg HAS 丁基疏水填料 | / | 1876815 |
| Phenyl beads 6FF (high sub), Loading Capacity: 36 mg BSA Phenyl beads 6FF (高取代) | / | 1876821 |
| Phenyl Beads 6FF (Low Sub), Loading Capacity: 24 mg BSA Phenyl beads 6FF (低取代) | / | 1876819 |
| Octyl Beads 4FF, Loading Capacity: 7 mg BSA 辛基填料 | / | 1876817 |
制剂与佐剂
| 品名 | CAS | 货号 |
|---|---|---|
| Alum adjuvant, PDI: 0.13 纳米级氢氧化铝佐剂 | 21645-51-2 | 921101 |
| Aluminium phosphate adjuvant L-磷酸铝佐剂 | 7784-30-7 | 986987 |
| L-MF59 L-MF59佐剂 | / | 9401099 |
| L-CpG1018, 1mg/ml L-CpG1018佐剂 | / | 9401102 |
| Squalane, 98% 角鲨烷 | 111-01-3 | 581708 |
| DL-α-Tocopherol, 96% DL-α-生育酚 | 10191-41-0 | 957498 |
| QS-21 QS-21佐剂 | 141256-04-4 | 902959 |
| D-(+)-Sucrose, 99.9%, for biochemistry D-(+)-蔗糖 | 57-50-1 | 971624 |
| D-(+)-Trehalose, 99%, anhydrous D-(+)-海藻糖 | 99-20-7 | 242508 |
| D-Mannitol, 98% D-甘露醇 | 69-65-8 | 351126 |
| Albumin from human serum, 96% 人血清白蛋白 | 70024-90-7 | 601386 |
| Tween 80 吐温 80 | 9005-65-6 | 437595 |
| Albumin from human serum, 96% 人血清白蛋白 | 70024-90-7 | 601386 |
| Cholesterol, 99%, plant origin 胆固醇 | 57-88-5 | 976999 |
| Cholesterol, 92.5%, for bio 胆固醇 | 57-88-5 | 992043 |
| N-[1-(2,3-Dioleyloxy)propyl]-N,N,N-trimethylammonium chloride, 98% (2,3-二油氧基丙基)三甲基氯化铵 | 132172-61-3 | 545592 |
| Ethanol, 99.8%, GR 无水乙醇 | 64-17-5 | 997145 危化品 |
| Citric acid sodium citrate powder, 10 mmol/L, pH 6.0 柠檬酸—柠檬酸钠粉剂 | / | 9456172 |
质量控制与检测
| 品名 | CAS | 货号 |
|---|---|---|
| Microporous membrane filters, PES, non-sterile, white, Ф47, 0.22μm, 50 pcs/pack 微孔滤膜 | / | 927818 |
| Microporous membrane filters, PES, non-sterile, white, Ф50, 0.22μm, 50 pcs/pack 微孔滤膜 | / | 965236 |
| Microporous membrane filters, hydrophobic PVDF, non-sterile, white, Ф47, 0.22μm, 50 pcs/pack 微孔滤膜 | / | 920889 |
| Microporous membrane filters, hydrophilic PVDF, non-sterile, white, Ф50, 0.22μm, 50 pcs/pack 微孔滤膜 | / | 960023 |
| Microporous membrane filters, hydrophilic PVDF, non-sterile, white, Ф13, 0.22μm, 200 pcs/pack 微孔滤膜 | / | 978955 |
| Precast Gels, For electrophoresis, 4-20%, 10well 蛋白预制胶 | / | 995487 |
| Not Required Decolorizing Commassie Blue Fast Staining Solution 免脱色考马斯亮蓝快速染色液 | / | 9456320 |
| SERVA Silver Staining Kit Native PAGE, For 25 gels 蛋白银染试剂盒 | / | 3507701 |
| Protein Color Marker, M.W. 1,200 - 31,000 Da 蛋白预染Marker | / | 929686 |
| Protein color Marker, M.W. 6,200 - 66200 Da 蛋白预染Marker | / | 1914014 |
| 彩色预染蛋白Marker(8-180kDa) 250μl*10 彩色预染蛋白Marker(8-180kDa) 250μl*10 | / | AFM-301M |
| 彩色预染蛋白Marker(8-270kDa) 250μl*10 彩色预染蛋白Marker(8-270kDa) 250μl*10 | / | AFM-302M |
| 彩色预染蛋白Marker(8-180kDa) 250μl*10 彩色预染蛋白Marker(8-180kDa) 250μl*10 | / | AFM-301M |
| CHO细胞宿主蛋白(CHOHCP)ELISA科研试剂盒 CHO细胞宿主蛋白(CHOHCP)ELISA科研试剂盒 | / | JM-06010O1 |
| CHO宿主细胞DNA残留检测试剂盒（荧光PCR法）冻存管；25T；3管/盒 CHO宿主细胞DNA残留检测试剂盒（荧光PCR法）冻存管；25T；3管/盒 | / | BNCC370235 |
| quantitative kit（Q-PCR Taqman probe） 毕赤酵母宿主细胞 DNA 检测试剂盒（PCR-荧光探针法） | / | 410010 |
| 支原体检测试剂盒 支原体检测试剂盒 | / | CA1080-200T |
| WB抗体剥离缓冲液(PVDF膜) WB抗体剥离缓冲液(PVDF膜) | / | AIWB-0015P |
| 超敏ECL发光液(飞克级) 超敏ECL发光液(飞克级) | / | AIWB-006M |
| Super ECL Plus Detection Reagent (component A), used with 1912570 Super ECL Plus超敏发光液(A液) | / | 946079 |
| Super ECL Plus Detection Reagent (component B), used with 946079 Super ECL Plus超敏发光液(B液) | / | 1912570 |
| CDP-Star, 98% CDP-Star 化学发光底物 | 160081-62-9 | 566933 |
| Luminol, 98% 鲁米诺 | 521-31-3 | 328061 |
| 3,3',5,5'-Tetramethylbenzidine, 99% 3,3',5,5'-四甲基联苯胺 | 54827-17-7 | 270119 |
| ELISA包被液(10x) ELISA包被液(10x) | / | C1055-500ml |
| BioSep SEC VV HPLC column, 300×7.8 mm 5μm, 1000Å 体积排阻生物分离柱 | / | 951394 |
| BioSep SEC VV-C HPLC column, 300×7.8 mm 5μm, 300 Å 体积排阻生物分离柱 | / | 9337677 |
| BioSep SEC PMA-MC10 HPLC column, 300×7.8 mm 10μm, 500Å 体积排阻生物分离柱 | / | 9337501 |
| BioSep ONs HPLC column, 300×7.8 mm 3μm, 300 Å 体积排阻生物分离柱 | / | 987822 |
| BioSep SAX Pr HPLC column, 250×4.6mm 5μm 离子交换生物分离柱 | / | 9337359 |
| BioSep SCX Pr HPLC column, 50×4.6mm 5μm 离子交换生物分离柱 | / | 9337372 |
| BioSep WAX Pr HPLC column, 250×4.6mm 5μm 离子交换生物分离柱 | / | 9337376 |
| BioSep HIC Pr-Butyl HPLC column, 35×4.6 mm 5μm 反相生物分离柱 | / | 9337407 |
| Special HPLC column for amino acid, 250×4.6 mm, 5 μm, 120 Å, pH 3-7.5 氨基酸专用液相色谱柱 | / | 2467378 |
| Special HPLC column for insulin, 300×7.8 mm, 3 μm, 80 Å, pH 2-7.5 胰岛素专用液相色谱柱 | / | 2467384 |
| DL-Dithiothreitol, 99%, for molecular biology DL-二硫苏糖醇 | 3483-12-3 | 926470 |
| Iodoacetamide, 99% 碘代乙酰胺 | 144-48-9 | 937994 |
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