
维百奥生物代理NIBSC品牌全系列产品
英国国家生物制品检定所(NIBSC)是全球生物制品标准化与质量控制的权威公立机构,隶属于英国卫生安全局。其核心使命是为世界卫生组织(WHO)制定、储存和分发国际生物标准品,确保疫苗、血液制品、基因治疗等关键医疗产品的有效性、安全性与质量一致性。作为WHO的全球合作中心,NIBSC的产品线覆盖疫苗、血液制品、治疗性生物药、诊断试剂及先进疗法,尤其在突发公共卫生事件(如流感、COVID-19)中,快速研发并提供关键标准品,支撑全球诊断、治疗和监管体系。

▍NIBSC产品线
NIBSC的产品以国际标准品和参考试剂为核心,覆盖以下领域:
● 疫苗相关标准品
⒈病毒疫苗:流感(季节性及大流行株)、脊髓灰质炎、麻疹、风疹、乙肝等疫苗的效价和抗原含量标准品。
⒉细菌疫苗:白喉/破伤风/百日咳(DTP)疫苗、脑膜炎球菌疫苗、肺炎球菌疫苗的标准品。
⒊COVID-19相关:SARS-CoV-2病毒RNA标准品、抗体标准品(用于血清学检测标准化)、疫苗效力评估标准品。
● 血液制品与凝血因子
⒈凝血因子:血友病治疗用的凝血因子Ⅷ、Ⅸ、von Willebrand因子等的活性标准品。
⒉血浆衍生物:免疫球蛋白、抗凝血酶、纤维蛋白原等的国际标准品。
⒊输血安全:HIV、乙肝、丙肝等血液传播病原体的检测标准品。
● 治疗性生物制品
⒈单克隆抗体:如英夫利昔单抗(infliximab)、阿达木单抗(adalimumab)的生物活性标准品。
⒉细胞与基因治疗产品:用于干细胞、CAR-T细胞治疗等的质量控制参考品。
⒊生长激素与细胞因子:如促红细胞生成素(EPO)、干扰素、白细胞介素的标准品。
● 诊断与检测标准品
⒈传染病诊断:HIV、HPV、寨卡病毒、结核病等病原体的核酸或抗体检测标准品。
⒉自身免疫与过敏:抗核抗体、过敏原(如花粉、尘螨)的参考试剂。
● 新兴领域产品
⒈基因编辑技术:CRISPR/Cas9活性标准品。
⒉生物类似药:为生物类似药提供比对参考原研药的标准品。
▍NIBSC部分产品列表
| Product Code | Blood |
| 19/114 | Anti-Human Neutrophil Antibody 3a WHO Reference Reagent |
| 18/248 | Von Willebrand Factor Concentrate (WHO 3rd International Standard) |
| 21/266 | 1st International Standard 2022 Anti-β2GPI IgG 200 IU/Vial |
| Product Code | Infectious diseases |
| 18/180 | 2nd International Standard for Diphtheria Antitoxin Equine |
| Dim9 | Diphtheria toxoid monoclonal antibody, clone Dim9 |
| DT05 | Diphtheria toxoid monoclonal antibody, clone DT05 |
| Product Code | Emerging viruses |
| 21/112 | First WHO International Standard for LASV RNA |
| 22/108 | Reference Panel for Lassa virus RNA |
| 21/110 | Working Reagent for Lassa virus RNA |
| 22/218 | Working Reagent for anti-monkeypox virus antibodies |
| Product Code | Influenza |
| 22/222 | Influenza Antigen A/Sydney/175/2022 (IVR-235) (H1N1) |
| 22/220 | Influenza Antigen A/Sydney/5/2021 (SAN-013) (H1N1) |
| 22/100 | Influenza Antigen A/Victoria/2570/2019 (IVR-215) (H1N1) |
| Influenza Antiserum | |
| 22/224 | Influenza anti-A/Sydney/5/2021-like (H1N1) HA serum |
| Influenza Virus | |
| 22/146 | Influenza Virus Infectious A/Brisbane/02/2018 (H1N1) |
| 22/178 | Influenza Virus Infectious A/Darwin/22/2021 (H3N2) NIB -130 |
| 22/144 | Influenza Virus Infectious A/Darwin/22/2021 (H3N2) SAN-014 |
| 22/180 | Influenza Virus Infectious A/Guizhou/Liuzhite/326/2022 (H3N2) CNIC-2206 |
| 22/138 | Influenza Virus Infectious A/Indiana/02/2020 (H1N1) |
| 22/172 | Influenza Virus Infectious A/Lyon/820/2021 (H1N1) NIB-132 |
| 22/140 | Influenza Virus Infectious A/Netherlands 00007/2021 (H3N2) SAN-012 |
| 22/158 | Influenza Virus Infectious A/Netherlands/00007/2021 (H3N2) NYMC X-377 |
| 22/136 | Influenza Virus Infectious A/North Carolina/01/2021 (H1N1) X-375 |
| 22/156 | Influenza Virus Infectious A/Norway/16606/2021 (H3N2) NYMC X373A |
| 22/200 | Influenza Virus Infectious A/Sydney/5/2021 (H1N1) |
| 22/142 | Influenza Virus Infectious A/Sydney/5/2021 (H1N1) SAN-013 |
| 22/174 | Influenza Virus Infectious A/Victoria/2570/2019 (H1N1) NYMC X-379 |
| 22/204 | Influenza Virus Infectious B/Austria/1359417/2021 (B-Victoria lineage) BVR-26 |
| 22/154 | Influenza Virus Infectious B/Connecticut/01/2021 (B-Victoria Lineage) |
| 21/388 | Influenza Virus Infectious B/Guangdong-Zhenjiang/1516/2021 (B-Victoria Lineage) |
| 22/134 | Influenza Virus Infectious BX-107A (B-Victoria Lineage) |
| 22/214 | Influenza Virus Infectious CBER-48A (A/Sydney/5/2021) (H1N1) |
| 22/234 | Influenza Virus Infectious IVR-235 (A/Sydney/175/2022) (H1N1) |
| 22/118 | Influenza Virus Infectious NIB-129 (H3N2) |
| 22/268 | Influenza Virus Infectious SAN-015 (A/Lyon/820/2021) (H1N1) |
| 21/382 | Influenza Virus Infectious X-367A (H3N2) |
| 21/384 | Influenza Virus Infectious X-369A (H3N2) |
| Product Code | Microbiome |
| 22/212 | NIBSC Reference Reagent for DNA extractions of gut microbiome samples (WC-Gut-RR) |
| 20/302 | WHO International Reference Reagent for GUT Microbiome analysis by NGS (Gut-Mix RR) |
| 20/304 | WHO Reference Reagent for GUT Microbiome analysis by NGS (DNA-Gut-HiLo) |
| Product Code | Monoclonal antibodies |
| 22/242 | Anti-pneumococcal serotype 11A monoclonal antibody |
| 22/256 | Anti-pneumococcal serotype 15A/B monoclonal antibody |
| 22/244 | Anti-pneumococcal serotype 15B monoclonal antibody |
| 22/258 | Anti-pneumococcal serotype 16F monoclonal antibody |
| 22/246 | Anti-pneumococcal serotype 17F monoclonal antibody |
| 22/260 | Anti-pneumococcal serotype 19F monoclonal antibody |
| 22/236 | Anti-pneumococcal serotype 2 monoclonal antibody |
| 22/248 | Anti-pneumococcal serotype 20 monoclonal antibody |
| 22/262 | Anti-pneumococcal serotype 23F monoclonal antibody |
| 22/264 | Anti-pneumococcal serotype 24F monoclonal antibody |
| 22/250 | Anti-pneumococcal serotype 33F monoclonal antibody |
| 22/266 | Anti-pneumococcal serotype 35B monoclonal antibody |
| 22/238 | Anti-pneumococcal serotype 4 monoclonal antibody |
| 22/240 | Anti-pneumococcal serotype 6B monoclonal antibody |
| 22/254 | Anti-pneumococcal serotype 6C monoclonal antibody |
| 32-1 | Filamentous Haemagglutinin monoclonal antibody, clone 32-1 |
| FHADETOX/6 | Filamentous Haemagglutinin monoclonal antibody, clone FHADETOX/6 |
| 1-7 | Fimbrae monoclonal antibody, clone 1-7 |
| G10F8C3 | Fimbrae monoclonal antibody, clone G10F8C3 |
| 3-5 | Pertactin Monoclonal antibody, Clone 3-5 |
| 69K/16 | Pertactin monoclonal antibody, clone 69K/16 |
| 629 e1 | Pertussis toxoid monoclonal antibody, clone 629E1 |
| PS21C2.2.1 | Pertussis toxoid monoclonal antibody, clone PS21C2.2.1 |
| 21/230 | 1st WHO Reference Reagent Tetanus Antitoxin Equine for use in Flocculation Test |
| 8E1-1H1.2.1 | Tetanus toxoid monoclonal antibody, clone 8E1-1H1.2.1 |
| TT010 | Tetanus toxoid monoclonal antibody, clone TT010 |
| Product Code | COVID-19 |
| 22/B896-01 | Anti-SARS-CoV-2 Verification Panel for Serology Assays |
| 101062 | HEK293T-ACE2-30F-PLP2 |
| 101037 | Inactivated (acetic acid + heat) SARS-Cov-2 Gamma (P.1 lineage) |
| 101047 | Inactivated (Acetic Acid + Heat)SARS-CoV-2 Omicron (BA.1 sublineage) |
| 21/338 | 1st International Standard for antibodies to SARS-CoV-2 variants of concern |
| 20/270 | SARS-CoV-2 Ag QC |
| 20/270-002 | SARS-CoV-2 Ag QC |
| 21/368 | SARS-Cov-2 Antigen 1st WHO International Standard |
| 101055 | SARS-CoV-2 Omicron (BA.2) |
| 101054 | SARS-CoV-2 Omicron BA.1.1 sublineage lot 28032022 |
| Product Code | Serology diagnostics |
| 03/104-022 | HTLV-1 (antibody) Monitor Sample |
| 20/168-002 | Monitor Sample for Anti HTLV-II |
| 20/168-003 | Monitor Sample for Anti HTLV-II |
| 21/B889-01 | QCRHCVQC1-Anti-HCV Quality Control Serum: Sample1 |
| 21/B882-01 | QCRHSV1QC1-Anti-HSV1 Quality Control Serum: Sample1 |
| 22/B891-01 | QCRTOXOIgMQC1 IgM Anti-Toxoplasma QC1 |