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[行业机构] 英国国家生物制品检定所(NIBSC)

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英国国家生物制品检定所(NIBSC)
英国国家生物制品检定所(NIBSC)  www.nibsc.ac.uk
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国家生物标准委员会 (NBSB) 是隶属于英国政府的一家非部门公共机构 (NDPB),它成立于 1975 年,是《议会法案》的法定团体。 委员会通过对国家生物学标准与控制研究院 (NIBSC) 的管理,确保生物产品的质量与安全,从而保障并促进公众的健康。

NIBSC提供对投入英国市场的生物药品的独立测试,尤其是用于英国儿童免疫计划的疫苗;它同时也是欧盟控制药品进入欧盟市场的官方药品控制实验室 (OMCL)。 如果出现不能满足药品存放要求或患者出现不良反应等问题,NIBSC 也可对已投入欧盟市场的产品进行检验。
NBSB 认为对 NIBSC工作的核心职能制定并维护一项既均衡而又主次分明的计划至关重要。
控制和评估生物药品。
开发和提供关键的生物学标准和其它参考资料。
开展针对任务的研究和开发工作。

NIBSC 战略目标:
对有关生物产品的问题给出回复和建议;
提供生物药品方面的国家科技力量,维持满足科学和药物学领域新发展需求的灵活性、专业知识和设施;
作为化验方法(如量化生物学活性以及确定生物产品特征和进行安全评估)方面的国际领先权威机构运营并得到认同;
在欧洲生物产品的控制和标准化方面,继续发挥科学基础开发的中心作用;
在生物药品法规的科学方面帮助国际社会达成共识,并籍于此,与世界卫生组织紧密合作;
在控制和标准化的关键领域实现和维护质量鉴定。

生物药品控制
药品中使用的生物物质包括病毒和细菌疫苗、从人类血液提取的产物、荷尔蒙以及其它储如细胞分裂素和生长素等治疗药物。
这些生物物质对药物学和公众健康做出了巨大贡献并发挥着越来越大的作用,它们大大改善了全世界的疾病预防、诊断和治疗。
生物药品是非常复杂的产品,正因为如此,大多数生物药品在投入使用前都会经过独立测试。 在英国和欧盟,生物产品在投入使用前会先提交到欧盟的其中一个 OMCL 进行测试。 确保疫苗的安全性尤其重要,因为它们将在全国范围内的免疫活动中用于大量健康的个人。
通过研究院的测试和评估工作,NIBSC的科学家们帮助确保了生物产品的安全和有效性,同时也帮助缩短了将新产品投入临床使用的时间。 新产品,如最新一代复合疫苗,需要采取新颖的方法加以控制。 作为基因革命带来的影响之一,生物产品在数量和复杂程度上的潜在大幅增长也需要有更为彻底的控制战略方案。

提供标准
用于确保生物产品潜能的复杂化验要求使用生物学活性标准(有一批物质被指定了活性单位并用作“基准”)。 世界卫生组织 (WHO) 国际标准系统提供了一组常用标准,它使得世界各地的质量测试结果具有可比性,也因此而重要非凡。 国际标准是“金标准”,各国以及各生产商都可据此制定出自己的生物学测试标准。
NIBSC 是目前世界上 WHO 国际标准和参考材料的主要制作人和分发人(提供 95% 以上的标准)。 对疫苗、治疗中的大多数生物技术产品以及其它许多生物产品的有效使用都取决于 NIBSC 所提供的国际生物学标准的可用性。

The National Biological Standards Board (NBSB) is a non-departmental public body (NDPB) of the UK **, established, in 1975, as a Statutory Body by Act of Parliament. The Board is responsible for safeguarding and advancing public health by assuring the quality and safety of biologicals, through its management of the National Institute for Biological Standards and Control (NIBSC).
NIBSC provides independent testing of biological medicines for the UK market, in particular with vaccines for the UK children's vaccination programme, and operates as an Official Medicines Control Laboratory (OMCL) of the European Union for release of medicines onto the EU market. NIBSC testing of products already released onto the EU market may also be carried out when particular problems arise such as failure of storage conditions or following adverse reactions in patients.
NBSB considers it essential to maintain a well balanced and clearly prioritised programme of work on the core functions of NIBSC's work.
Control and evaluation of biological medicines.
Development and provision of key biological standards and other reference materials.
Mission-orientated research and development.
NIBSC STRATEGIC AIMS:
To respond to and advise on public health problems involving biologicals;
To provide a national scientific capacity in the field of biological medicine, and to maintain the flexibility, expertise and facilities needed to address new developments in science and medicine;
To operate, and be recognised, as a leading international authority on methods of assay such as those to quantify biological activity and to characterise and assess the safety of biologicals;
To maintain a central role in the development of the scientific basis for control and standardisation of biologicals within Europe;
To assist in the development of international consensus on scientific aspects of the regulation of biological medicines and, in this respect, work closely with the World Health Organisation;
To achieve and maintain Quality Accreditation in key areas of control and standardisation.
To read more about Biological standardization:
A HISTORY OF BIOLOGICAL STANDARDIZATION
The characterization and measurement of complex molecules important in clinical and research medicine. Contributions from the UK 1900-1995. What, why, how, where and by whom: A personal account by D.R. Bangham
This document is provided here with the permission of the Society of Endocrinology

NIBSC 标准品
英国国家生物标准与检定所(National Institute for Biological Standards and Control, NIBSC),同时它又是世界卫生组织WHO的一个国际标准品供应中心,它的核心工作是制备、保存和分发WHO用于检测全球生物制品质量的标准品。NIBSC制备的流感毒株和检测抗原、抗血清标准品,保障了各厂家顺利的研究和生产。
Type of standard Product Number
Acarus Siro Extract 77/662
Acellular Pertussis Vaccine - 1st IS JNIH-3
Activin A, Human, Recombinant 91/626
Alpha-1-Antitrypsin, plasma derived 05/162
Alpha-Foetoprotein AFP
Ancrod 74/581
Angiotensin I 71/328
Angiotensin I Human Type Synthetic 86/536
Angiotensin II 70/302
Angiotensin II 86/538
Anti Dengue, WHO Reference Panel 05/248
Anti Filamentous Haemagglutinin Monoclonal Antibody (12G10) 99/574
Anti Filamentous Haemagglutinin Monoclonal Antibody (1C6) 99/570
Anti Hepatitis C Virus 06/188-004
Anti Meningococcal Serosubtype P1.9 Monoclonal Antibody 05/190
Anti Meningococcal Serotype P2.2b Monoclonal Antibody 05/192
Anti nuclear ribonucleoprotein(nRNP) autoantibody W1063
Anti Poliovirus serum types 1,2 and 3 82/585
Anti smooth muscle(anti actin) autoantibody. W1062
Anti-A and Anti-b in IVIG: Positive and Negative control panel. (2 ampoules of 07/306 and 2 ampoules of 07/308) 08/270
Anti-A minimum potency reference preparation 03/188
Anti-Aspergillus fumigatus Serum, Human 78/545
Anti-B minimum potency reference preparation 03/164
Anti-Birch Pollen Serum, Human 76/525
Anti-Bordetella pertussis serum (Human) 89/530
Anti-B-pertussis Fimbriae 2 Monoclonal Antibody 04/154
Anti-B-pertussis Fimbriae 3 Monoclonal Antibody 04/156
Anti-Brucella Ovis Serum, Ovine BOVISDS
Anti-C complete blood typing serum,human W1004
Anti-c Incomplete blood typing serum, human W1007
anti-c Serum, Human 84/628
Anti-Canine Distemper Serum CDS
Anti-Canine Hepatitis Serum CHS
Anti-Cat Fur Serum, Human 79/530
Anti-Cocksfoot Serum, Human 77/503
Anti-D (Rho) Antibodies, Human 73/515
Anti-D for assuring operator and test performance 07/304
Anti-D for use with papain preparation 92/658 91/562
Anti-D Immunoglobulin 01/572
Anti-D Immunoglobulin Control 99/728
Anti-D Minimum Potency Standard for blood grouping reagents 99/836
Anti-D Pteronyssinus Serum, Human 77/584
Anti-Dengue Virus Types 1+2+3+4, Human 02/186
Anti-Dysentery (shiga) serum, Equine DY
Anti-E complete blood typing serum, human W1005
Anti-Echinococcus Serum, Human ECHS
Anti-Ferritin Monoclonal Antibody (1) 87/654
Anti-Ferritin Monoclonal Antibody (2) 87/662
Anti-Filamentous haemagglutinin Monoclonal Antibody (2E9) 99/572
Anti-Granulocyte Macrophage Colony Stimulating Factor Serum 97/538
Anti-HBc (Anti-hepatitis B core antigen) 95/522
Anti-HBs immunoglobulin 07/164
Anti-HCV (1 in 8 dilution) 06/190-004
Anti-Hepatitis A Immunoglobulin, Human (W1041) 97/646
Anti-hepatitis E Serum, Human 95/584
Anti-Hib Human Reference Serum 96/536
Anti-HPA-1a minimum potency reagent 05/106
Anti-HPA-1a standard 03/152
Anti-HPA-3a(minimum potency) 03/190
Anti-HPA-5b (Minimum Potency) 99/666
Anti-Human Globulin 96/666
Anti-human papillomavirus type 16 serum 05/134
Anti-Japanese Encephalitis (Anti-JE) Virus Control Plasma, Human 02/184
Anti-Japanese Encephalitis Virus Plasma, Human 02/182
Anti-Measles serum 97/648
Anti-Meningiococcal Serosubtype P1.6 mAb 03/210
Anti-Meningococcal human reference serum CDC1992 99/706
Anti-Meningococcal immunotype L3,7,9 mAb 01/412
Anti-Meningococcal Serogroup A mAb 95/674
Anti-Meningococcal Serogroup B mAb 95/750
Anti-Meningococcal Serogroup C mAb 95/678
Anti-Meningococcal Serogroup W-135 mAb 04/246
Anti-Meningococcal Serosubtype P1.10 mAb 03/224
Anti-Meningococcal Serosubtype P1.12 mAb 04/122
Anti-Meningococcal Serosubtype P1.13 mAb 03/236
Anti-Meningococcal Serosubtype P1.14 mAb 03/142
Anti-Meningococcal Serosubtype P1.15 mAb 02/144
Anti-Meningococcal Serosubtype P1.16 mAb 01/538
Anti-Meningococcal Serosubtype P1.19 mAb 04/248
Anti-Meningococcal Serosubtype P1.2 mAb 02/178
Anti-Meningococcal Serosubtype P1.3 mAb 02/320
Anti-Meningococcal Serosubtype P1.4 mAb 02/148
Anti-Meningococcal Serosubtype P1.5 mAb 03/226
Anti-Meningococcal Serosubtype P1.7 mAb 01/514
Anti-Meningococcal Serosutype P1.1 mAb 03/114
Anti-Meningococcal Serotype P2.2a mAb 02/180
Anti-Meningococcal Serotype P3.1 mAb 04/198
Anti-Meningococcal Serotype P3.15 mAb 02/310
Anti-Meningococcal Serotype P3.21 mAb 03/182
Anti-Meningococcal Serotype P3.4 mAb 02/308
Anti-Mycoplasma gallisepticum Serum MGDS
Anti-Newcastle Disease Serum NDS
Anti-Nuclear Factor Serum (Homogenous) Human 66/233
Anti-Nuclear factor serum,homogenous(66/233) W1064
Anti-Nucleolar Factor Plasma, Human 68/340
Anti-Parvovirus B19, plasma, human 01/602
Anti-PT S1 subunit Monoclonal Antibody (10D6) 99/512
Anti-PT S1 subunit Monoclonal Antibody (11D9) 99/522
Anti-PT S1 subunit Monoclonal Antibody (1B7) 99/506
Anti-PT S1 subunit Monoclonal Antibody (1D7) 99/508
Anti-PT S1 subunit Monoclonal Antibody (3F11) 99/510
Anti-PT S1 subunit Monoclonal Antibody (4D10) 99/524
Anti-PT S1 subunit Monoclonal Antibody (8G4) 99/514
Anti-PT S1 subunit Monoclonal Antibody (E1E) 99/516
Anti-PT S1 subunit Monoclonal Antibody (E2E) 99/518
Anti-PT S1subunit Monoclonal Antibody (3F10) 99/520
Anti-PT S2 subunit Monoclonal Antibody (2H3) 99/538
Anti-PT S2 subunit Monoclonal Antibody (3A12) 99/536
Anti-PT S2 subunit Monoclonal Antibody (9G8) 99/540
Anti-PT S23 subunit Monoclonal Antibody (10B5) 99/530
Anti-PT S23 subunit Monoclonal Antibody (10C9) 99/528
Anti-PT S23 subunit Monoclonal Antibody (11E6) 99/526
Anti-PT S23 subunit Monoclonal Antibody (3F6) 99/534
Anti-PT S23 subunit Monoclonal Antibody (G9A) 99/532
Anti-PT S3 subunit Monoclonal Antibody (2E12) 99/548
Anti-PT S3 subunit Monoclonal Antibody (4G5) 99/546
Anti-PT S3 subunit Monoclonal Antibody (6F8) 99/550
Anti-PT S3 subunit Monoclonal Antibody (7E10) 99/542
Anti-PT S3 subunit Monoclonal Antibody (7G11) 99/544
Anti-PT S4 subunit Monoclonal Antibody (1H2) 99/562
Anti-PT S4 subunit Monoclonal Antibody (6B3) 99/556
Anti-PT S4 subunit Monoclonal Antibody (6D6) 99/566
Anti-PT S4 subunit Monoclonal Antibody (6G8) 99/558
Anti-PT S4 subunit Monoclonal Antibody (7F2) 99/554
Anti-PT S4 subunit Monoclonal Antibody (9C6) 99/564
Anti-PT S4 subunit Monoclonal Antibody (9F3) 99/560
Anti-PT S5 subunit Monoclonal Antibody (7E3) 99/568
Anti-Q Fever Serum, Bovine QF
Anti-rabies Immunoglobulin, Human RAI
Anti-rubella Immunoglobulin, Human RUBI-1-94
Anti-Rubella Serum, Human 67/182
Anti-Rye Grass Serum, Human 85/551
Anti-Salmonella Pullorum Serum (Std. Form S) SPDS-S2
Anti-Salmonella Pullorum Serum (Variant Form V) SPDS-V
Anti-Staphylococcal P-V Leucocidin antiserum, Equine 64/012
Anti-Staphylococcal P-V Leucocidin serum, Equine SPLS
AntiStreptolysin O 97/662
Anti-Swine Fever Serum SFS
Anti-syphilitic plasma IgG (human) 05/122
Anti-syphilitic plasma IgG and IgM (human) 05/132
Antithrombin Concentrate, Human 06/166
Antithrombin, Plasma, Human 93/768
Anti-Thyroglobulin Serum, Human 65/093
Anti-thyroid Microsome Serum, Human 66/387
Anti-tick borne encephalitis serum TILI
Anti-tick borne encephalitis serum TISA
Anti-Toxoplasma IgG, Human 01/600
Anti-Varicella zoster immunoglobulin W1044
Anti-Varicella-Zoster Antibody 90/690
Anti-Yellow Fever Serum, monkey YF
Arginine Vasopressin 77/501
Aspergillus Fumigatus Extract 78/575
Atrial Natriuretic Factor, Human 85/669
Autoimmune Antibody to Human Spermatazoa 69/065
B19 DNA NAT assays.2nd I.S. 99/802
Basic Fibroblast Growth Factor (Human, rDNA derived) 90/712
Batroxobin 93/526
Bee Venom 78/628
Beta Thromboglobulin, Purified Human 83/501
Beta-2 Microglobulin B2M
Biotinylated Brad-5 (Bio-Brad-5) 99/698
Birch Pollen Extract 84/522
Blood Coagulation Factor IX Concentrate, Human, 4th International Standard” 07/182
Blood Coagulation Factor V, Plasma(1st I.S.) 03/116
Blood Coagulation Factor VII Concentrate(1st I.S.) 97/592
Blood Coagulation Factor VIIa, Concentrate, Human, 2nd International Standard” 07/228
Blood Coagulation Factor VIII and Von Willebrand Factor in Plasma (5th I.S.) 02/150
Blood Coagulation Factor VIII Concentrate, Human 02/122
Blood Coagulation Factor VIII:C Concentrate, Human;7th I.S. 99/678
Blood Coagulation Factor Xa, Bovine 75/595
Blood Coagulation Factor XI Plasma, Human(1st I.S.) 04/102
Blood Coagulation Factor XIII, Plasma, Human. 02/206
Blood Coagulation Factors II and X Concentrate(3rd I.S.) 98/590
Blood Coagulation Factors II, IX,and X Concentrate, 6th British Working Standard. 07/326
Blood Coagulation Factors II, VII, IX, X Plasma(3rd I.S.) 99/826
Blood Coagulation Factors IXa Concentrate, Human, recombinant(1st I.S.) 97/562
Bone morphogenetic Protein-2 (Human, rDNA derived) 93/574
Bordetella pertussis (W28) LPS 2ug 89/594
Bordetella pertussis (W28) LPS25ug 89/670
Bordetella pertussis (Whole cell vaccine) 3BRP 88/522
Bordetella pertussis 69kD 90/654
Bordetella pertussis anti 69kD serum (sheep) 97/558
Bordetella pertussis anti FHA serum (mouse) JNIH-11
Bordetella pertussis anti FHA serum (sheep) 97/564
Bordetella pertussis anti Fim3 serum (sheep) 97/574
Bordetella pertussis anti serum (mouse) 1RR 97/642
Bordetella pertussis anti-agglutinogen 1(rabbit) 89/596
Bordetella pertussis anti-agglutinogen 2 (rabbit) 89/598
Bordetella pertussis anti-agglutinogen 3 (rabbit) 89/600
Bordetella pertussis filamentous haemagglutinin (FHA) JNIH-4
Bordetella pertussis PT anti serum (sheep) 97/572
Bordetella pertussis PT( LPF) anti serum, (mouse) JNIH-12
Bordetella Pertussis toxin (PT) 90/518
Bordetella pertussis toxin (PT) 1st IS JNIH-5
Bordetella pertussis, filamentous haemagglutinin (FHA) 90/520
Botulinum Antitoxin Equine Type A 59/021
Botulinum Antitoxin Equine Type B 60/001
Botulinum Antitoxin Equine Type B BUSB
Botulinum Antitoxin Equine Type C 01/508
Botulinum Antitoxin Equine Type D 01/510
Botulinum Antitoxin Equine Type D 61/001
Botulinum Antitoxin Equine Type E 02/318
Botulinum Antitoxin Equine Type F 01/506
Botulinum Antitoxin Equine Type G 01/512
Botulinum Antitoxin Human 00/500
Brain-derived Neurotrophic Factor (Human, rDNA derived) 96/534
C- Peptide of Human Insulin 84/510
Calcitonin, ASU 1-7 Eel Calcitonin Analogue (Elcatonin) 84/614
Calcitonin, Eel 88/556
Calcitonin, Human 89/620
Calcitonin, Salmon 98/586
Carcinoembryonic Antigen (CEA), Human 73/601
Cholera Antitoxin, Goat CHAN
Cholera Vaccine (Inaba) 73/554
Chorionic Gonadatrophin, beta core fragment, Human 99/708
Chorionic Gonadatrophin, intact, Human 99/688
Chorionic Gonadotrophin alpha subunit, Human 75/569
Chorionic Gonadotrophin alpha Subunit, Human, for Radioiodination 76/508
Chorionic Gonadotrophin beta Subunit, Human 75/551
Chorionic Gonadotrophin beta, Human, for Radioiodination 75/535
Chorionic Gonadotrophin, alpha subunit, Human (purified) 99/720
Chorionic Gonadotrophin, beta subunit, human 99/650
Chorionic Gonadotrophin, Human 75/589
Chorionic Gonadotrophin, Human, for Radioiodination 75/533
Chorionic Gonadotrophin, nicked beta subunit, Human 99/692
Chorionic Gonadotrophin, nicked, human 99/642
Ciliary Neurotrophic Factor (Human, rDNA derived) 94/684
Clostridium novyi (alpha) Toxoid COT
Clostridium Perfringens Beta Antitoxin 2CPBETAAT
Clostridium Perfringens Beta Toxoid CWBETATD
Clostridium Perfringens Epsilon Antitoxin 2CPEPSILONAT
Clostridium Perfringens Epsilon Toxoid CWEPSILONTD
Clostridium Sordellii anti-serum (1st International standard) 09/154
Cocksfoot Pollen Extract 75/506
Control Guinea Pig Serum 98/686
Corticotrophin (ACTH), Human 74/555
Corticotrophin (ACTH), Porcine 59/016
Corticotrophin (ACTH), Porcine 74/586
C-Reactive Protein, Human 85/506
Dermatophagoides Pteronyssinus Extract 82/518
Diphtheria (Schick) Test Toxin STT
Diphtheria and Tetanus Antitoxin, Guinea Pig Serum 98/572
Diphtheria Antitoxin Human Serum 00/496
Diphtheria Antitoxin, Equine 07/200
Diphtheria Antitoxin, Equine 66/153
Diphtheria Antitoxin, Equine, for Flocculation Test 63/007
Diphtheria Toxoid for use in Flocculation Test. 02/176
Diphtheria Toxoid, Plain 69/017
Dog (Canis Familiaris) Hair Dander Extract 84/685
Endotoxin 94/580
Epidermal Growth Factor (1-52) (Human, rDNA derived) 91/550
Epidermal Growth Factor (Human, rDNA derived) 91/530
Erythropoietin, Human recombinant 88/574
Erythropoietin, Human, Urinary 67/343
Factor V Leiden, Human gDNA, 1st International Genetic Reference Panel 2004 04/224
FEIBA Concentrate 1st NIBSC Working Reference Standard 06/172
Ferritin, Human, recombinant 94/572
Fibrinogen Concentrate, Human, 1st International Standard 98/614
Fibrinogen, Plasma, Human 98/612
FMS-like tyrosine kinase 3 ligand (Human, rDNA derived) 96/532
Folate, Whole Blood 95/528
Follicle Stimulating Hormone and Luteinizing Hormone, Human Urinary 98/704
Follicle Stimulating Hormone, Human, recombinant 92/510
Follicle Stimulating Hormone, Human, recombinant 92/642
Follicle Stimulating Hormone, Pituitary 83/575
Follicle Stimulating Hormone, urofollitropin Human Urinary 92/512
Follicle Stimulating Hormone/Luteinizing Hormone, Human Pituitary 94/632
Fragile X Syndrome gDNA Genetic Reference Panel 08/158
Gas Gangrene (Cl. Perfringens(Cl. Welchii) Type A), Equine 59/015
Gas Gangrene Antitoxin (Cl. Histolyticum), Equine 63/005
Gas Gangrene Antitoxin (Cl. Noyvi), Equine OE
Gas Gangrene Antitoxin (Cl. Oedematiens), Equine 64/024
Gas Gangrene Antitoxin (Cl. Perfringens alpha antitoxin) Equine PE
Gas Gangrene Antitoxin (Cl. Septicum), Equine 64/014
Gas Gangrene Antitoxin (Cl. Septicum), Equine VI
Gastrin II, Porcine 66/138
Glucagon, Porcine 69/194
Glycyphagus destructor Extract 77/664
Granulocyte Colony Stimulating Factor (Human, rDNA derived) 88/502
Granulocyte Macrophage Colony Stimulating Factor (Human, rDNA derived) 88/646
Granulocyte Macrophage Colony Stimulating Factor (Mouse rDNA derived) 91/658
Growth Hormone, Human, Pituitary 80/505
Haemiglobincyanide 98/708
Haemoglobin A2 Lysate, Raised 89/666
Haemoglobin F Lysate, Raised 85/616
Haemophilia A, Intron-22 inversion, gDNA, Genetic Reference Panel 08/160
Haemophilus influenzae b PRP 02/208
HBV DNA Working reagent for Nucleic Acid Amplification Techniques 05/148
HCV RNA Genotype Panel for Nucleic acid amplification techniques 08/264
HCV RNA Working Reagent for Nucleic Acid Amplification Techniques 02/264-001
Heparin, Porcine, Mucosal 97/578
Hepatitis A Vaccine, inactivated 95/500
Hepatitis A Virus RNA NAT Assays 00/560
Hepatitis A Virus RNA Working Reagent for NAT assays 01/488
Hepatitis B Surface Antigen (HBsAg) subtype adw2, genotype A 00/588
Hepatitis B Surface Antigen 0.2IU/ml 07/288-001
Hepatitis B Surface Antigen Monitor Sample 07/286-002
Hepatitis B Surface Antigen subtype adw2, genotype A Reference Panel 03/262
Hepatitis B Virus DNA for nucleic acid amplification techniques 97/750
Hepatitis C Virus (HCV) RNA 06/100
Hepatocyte Growth Factor/Scatter Factor (Human, rDNA derived) 96/564
Hepatocyte Growth Factor/Scatter Factor (precursor), (Human rDNA derived) 96/556
HIV (antibody), 1st International Reference Panel 02/210
HIV-1 (antibody) (1 in 5 dilution) British Working Standard 99/710-011
HIV-1 (antibody), British Working Standard 99/750-011
HIV-1 P24 Antigen 90/636
HIV-1 RNA Genotype panel for NAT Assays 01/466
HIV-1 RNA working reagent (high copy number) for NAT assays (PWS-2) 99/636-004
HIV-1 RNA Working Reagent 1 (PWS-1) for NAT Assays 99/634-005
HIV-1 RNA Working Reagent 3 for NAT Assays 05/158-002
HIV-1 RNA, 2nd International Standard 97/650
HIV-2 (antibody) Monitor sample 99/674-009
HLA-A Genotyping Reference Panel. 05/208-001
HPV 16 DNA 06/202
HPV 18 DNA 06/206
HTLV-1 (antibody) Monitor Sample 03/104-007
Human Plasma Anti-Influenza H5 07/150
Human Serum Vitamin B12, Pernicous anaemia 82/652
Immunoglobulin D (IgD) Serum, Human 67/037
Immunoglobulins G, A & M Serum Human 67/099
Immunoglobulins G, A, M Serum Human 67/086
Influenza anti A/Anhui/1/05 (H5) HA serum (IBCDC-RG6) (Sheep SH477) 07/338
Influenza anti A/Anhui/1/05 (H5) HA serum (IBCDC-RG6) (sheep SH477) 08/142
Influenza anti A/Bangkok/1/79 Serum (sheep) 80/525
Influenza anti A/Beijing/262/95 Serum (sheep) 98/772
Influenza anti A/Beijing/32/92 (H3N2) Serum (sheep) 93/518
Influenza anti A/Beijing/352/89 (H3N2) Serum (sheep) 92/632
Influenza anti A/Brazil/11/78 Serum (goat) 79/516
Influenza anti A/Brisbane/10/2007- like HA serum 08/246
Influenza Anti A/California/7/2009 (H1N1)v HA serum (sheep 506 and 507) 09/152
Influenza anti A/California/7/2009 (H1N1)v HA serum (Sheep 506) 09/142
Influenza anti A/Chile/1/8 Serum(sheep) 84/640
Influenza anti A/England/427/88 Serum(sheep) 88/846
Influenza anti A/Equine/Kentucky/1/81 HA Serum (sheep) 85/516
Influenza anti A/equine/Miami/63 (H3N8) Serum(goat) 84/677
Influenza anti A/equine/Newmarket/1/93 Serum(sheep) 97/610
Influenza anti A/Equine/Newmarket/2/93 (H3N8) HA Serum (SH-376) 97/614
Influenza anti A/equine/Prague/56 (H7N7) Serum(goat) 84/673
Influenza anti A/Guangdong/39/89 Serum(sheep) 90/504
Influenza anti A/Johannesburg/33/94 Serum(sheep) 95/524
Influenza anti A/Leningrad/360/86 Serum (sheep) 87/578
Influenza anti A/Mississippi/1/85 Serum(sheep) 86/590
Influenza anti A/Nanchang/933/95 (H3N2) 97/612
Influenza anti A/New Caledonia/20/99 HA Serum (sheep) 04/260
Influenza anti A/New Jersey/8/76 (H1N1) Serum(sheep) 77/531
Influenza anti A/New York/55/2004 HA Serum (sheep) 04/262
Influenza anti A/Panama/2007/99 Serum (sheep) 01/452
Influenza anti A/Panama/2007/99 Serum (sheep) 02/102
Influenza anti A/Panama/2007/99 Serum (sheep) 02/338
Influenza anti A/Philippine/2/82 Serum (sheep) 83/545
Influenza anti A/Shanghai/24/90 (H3N2) Serum (sheep) 93/522
Influenza anti A/Shanghai/9/93 Serum(sheep) 94/504
Influenza anti A/Sichuan/2/87 Serum(sheep) 88/672
Influenza anti A/Solomon Islands/3/2006 (H1N1) (IVR-145) HA Serum (sheep 467,468,469,470) 07/104
Influenza anti A/Taiwan/1/86 Serum (H1N1) 95/536
Influenza anti A/Taiwan/1/86 Serum (sheep) 91/612
Influenza anti A/Texas/1/77 Serum (sheep) 78/569
Influenza anti A/turkey/Turkey/1/05 (NIBRG-23) HA serum(sheepSH465 & SH466) 06/192
Influenza anti A/turkey/Turkey/1/05(N1) NA Serum (NIBRG-74) (Sheep SH485) 08/126
Influenza anti A/Victoria/3/75 Serum(goat) 76/547
Influenza anti A/Wisconsin/67/2005 Serum (sheep) 05/236
Influenza anti A/Wyoming/03/03 Serum 03/212
Influenza anti B Neuraminidase Serum (Sheep SH463) 05/252
Influenza anti B/ Neuraminidase Serum 04/228
Influenza anti B/Ann Arbor/1/86/HA Serum (sheep) 86/592
Influenza anti B/Beijing/1/87 Serum(sheep) 88/678
Influenza anti B/Guangdong/120/2000 Serum (sheep) 01/450
Influenza anti B/Harbin/7/94/HA Serum (sheep) 98/604
Influenza anti B/Hong Kong/8/73 Serum(sheep) 77/568
Influenza anti B/Jiangsu/10/2003 HA Serum (sheep) 04/242
Influenza anti B/Johannesburg/5/99/ Serum (sheep) 00/556
Influenza anti B/Malaysia/2506/2004-HA Serum (sheep) 07/184
Influenza anti B/Panama/45/90 Serum(sheep) 94/520
Influenza anti B/Shangdong/9/97 Serum (sheep) 03/110
Influenza anti B/Singapore/222/79 Serum 80/523
Influenza anti B/USSR/100/83 Serum(sheep) 84/636
Influenza anti B/Yamagata/16/88 Serum(sheep) 92/582
Influenza anti B/Yamanashi/166/98 Serum (sheep) 00/442
Influenza anti N1 Neuraminidase Serum 04/230
Influenza anti N2 Neuraminidase Serum(prepared from A/Wyoming/3/2003) 04/258
Influenza Anti-A/Brisbane/59/2007 (IVR-148) HA Serum (Sheep 482, 483, 484) 08/112
Influenza Anti-B/Florida/4/2006 HA serum (sheep 478, 479) 07/356
Influenza Antigen A/Anhui/1/05 (H5N1) IBCDC-RG-6 07/290
Influenza Antigen A/Bangkok/1/79 80/517
Influenza Antigen A/Beijing/262/95 97/760
Influenza Antigen A/Beijing/32/92 93/500
Influenza Antigen A/Brazil/11/78 79/560
Influenza Antigen A/Brazil/11/78 83/550
Influenza Antigen A/Brisbane/10/2007-like (Prepared from A/Uruguay/716/2007 (NYMC X-175C)) 08/278
Influenza Antigen A/Brisbane/59/2007 (IVR-148) (H1N1) 08/100
Influenza Antigen A/California/7/2009 (H1N1)v (NYMC-179A) (Egg derived) 09/146
Influenza Antigen A/Chile/1/83 84/538
Influenza Antigen A/England/427/88 88/654
Influenza Antigen A/Equine/Kentucky/1/81 85/520
Influenza Antigen A/Equine/Miami/63 87/510
Influenza Antigen A/Equine/Newmarket/1/93 97/596
Influenza Antigen A/Equine/Newmarket/2/93 97/584
Influenza Antigen A/Equine/Prague/56 (H7N7) 85/553
Influenza Antigen A/Guizhou/54/89 90/502
Influenza Antigen A/Johannesburg/33/94 95/516
Influenza Antigen A/Johannesburg/82/96 97/518
Influenza Antigen A/Leningrad/360/86 87/584
Influenza Antigen A/Mississippi/1/85 86/576
Influenza Antigen A/New Caledonia/20/99 01/614
Influenza Antigen A/New Caledonia/20/99 02/336
Influenza Antigen A/New Caledonia/20/99 06/170
Influenza Antigen A/New Caledonia/20/99 (IVR-116) 03/258
Influenza Antigen A/New Jersey/8/76 77/530
Influenza Antigen A/New York/55/2004 (H3N2) (NYMC X-157) 04/264
Influenza Antigen A/OMS/5389/88 89/568
Influenza Antigen A/Philippines/2/82 83/537
Influenza Antigen A/Shangdong/9/93 94/516
Influenza Antigen A/Shanghai/16/89 90/500
Influenza Antigen A/Shanghai/24/90 93/516
Influenza Antigen A/Sichuan/2/87 87/714
Influenza Antigen A/Solomon Islands/3/2006 (IVR-145)(H1N1) 07/102
Influenza Antigen A/Sydney/5/97 99/614
Influenza Antigen A/Sydney/5/97 99/624
Influenza Antigen A/Taiwan/1/86 94/510
Influenza Antigen A/Texas/1/77 78/560
Influenza Antigen A/Texas/36/91 92/530
Influenza Antigen A/Texas/36/91 95/510
Influenza Antigen A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 07/112
Influenza Antigen A/USSR/92/77 79/552
Influenza Antigen A/USSR/92/77 79/558
Influenza Antigen A/Wisconsin/67/2005 - Like 05/234
Influenza Antigen A/Wisconsin/67/2005 (H3N2) (NYMCX-161) 06/106
Influenza Antigen A/Wisconsin/67/2005 (H3N2) (NYMCX-161-B) 06/120
Influenza Antigen A/Wyoming/03/03 03/220
Influenza Antigen B/ Jiangsu/10/2003 04/202
Influenza Antigen B/Ann Arbor/1/86 86/630
Influenza Antigen B/Beijing/7/87 88/554
Influenza Antigen B/Brisbane/60/2008-like 08/352
Influenza Antigen B/Florida/4/2006 08/140
Influenza Antigen B/Guangdong/120/2000 01/546
Influenza Antigen B/Harbin/7/94 97/748
Influenza Antigen B/Hong Kong/8/73 79/568
Influenza Antigen B/Johannesburg/5/99 00/546
Influenza Antigen B/Malaysia/2506/2004 08/184
Influenza Antigen B/Norway/1/84 84/542
Influenza Antigen B/Panama/45/90 94/500
Influenza Antigen B/Shangdong/7/97 98/774
Influenza Antigen B/Singapore/222/79 80/519
Influenza Antigen B/Victoria/2/87 87/774
Influenza Antigen B/Yamagata/16/88 92/628
Influenza Antigen B/Yamanashi/166/98 99/586
Influenza Antigen B/Yamanashi/166/98 99/828
Influenza Antiserum B/Brisbane/60/2008-like (Sheep SH501 SH502) 08/354
Inhibin A, Human, recombinant 91/624
Inhibin B, Human 96/784
Inhibin, Porcine 86/690
Insulin Like Growth Factor I 02/254
Insulin, Bovine 83/511
Insulin, Human 66/304
Insulin, Human 83/500
Insulin, Porcine 83/515
Insulin-Like Growth Factor Binding Protein-3 93/560
Insulin-like growth factor-1 91/554
Insulin-like growth factor-II (Human rDNA derived) 96/538
Interferon alpha (Human, leukocyte derived) 94/784
Interferon alpha Concensus Sequence (Human rDNA derived) 94/786
Interferon Alpha n1 (Human lymphoblastoid cell derived) 95/568
Interferon Alpha n3 (Human, leukocyte derived) 95/574
Interferon alpha-1/8 (Human, rDNA derived) 95/572
Interferon alpha-1D, (Human rDNA derived) 83/514
Interferon alpha-2a (Human, rDNA derived) 95/650
Interferon alpha-2b (Human, rDNA derived) 95/566
Interferon alpha-2c (Human, rDNA derived) 95/580
Interferon Beta (Human, rDNA; CHO cell-derived; Glycosylated) 00/572
Interferon Beta Ser 17 Human, recDNA, E-coli-derived, non-glycosylated 00/574
Interferon Beta, Human, Fibroblast Cell-Derived, Glycosylated 00/576
Interferon Gamma (Human, Leukocyte derived) 82/587
Interferon Gamma (Human, rDNA derived) 87/586
Interferon Omega (Human, rDNA derived) 94/754
Interferon, Chick 67/018
Interleukin - 18 (Human rDNA derived) 03/200
Interleukin-1 alpha (Human rDNA derived) 86/632
Interleukin-1 alpha (Human, rDNA derived) 86/678
Interleukin-1 alpha (Mouse, rDNA derived) 93/672
Interleukin-1 Beta (Human, rDNA derived) 86/552
Interleukin-1 beta (Human, rDNA derived) 86/680
Interleukin-1 beta (Mouse, rDNA derived) 93/668
Interleukin-1 Receptor Antagonist (IL-1ra) (Human, rDNA derived) 92/644
Interleukin-10 (Human rDNA derived) 93/722
Interleukin-11 (Human, rDNA derived) 92/788
Interleukin-12 (Human, rDNA derived) 95/544
Interleukin-13 (Human, rDNA derived) 94/622
Interleukin-15 (Human, rDNA derived) 95/554
Interleukin-17 Human rec DNA 01/420
Interleukin-2 (Human, Jurkat derived) 86/504
Interleukin-2 (Human, rDNA derived) 86/564
Interleukin-2 (Mouse, rDNA derived) 93/566
Interleukin-2 Soluble Receptor (human, rDNA derived) 97/600
Interleukin-3 (Human, rDNA derived) 91/510
Interleukin-3 (Mouse, rDNA derived) 91/662
Interleukin-4 (Human, rDNA derived) 88/656
Interleukin-4 (Mouse, rDNA derived) 91/656
Interleukin-5 (Human, rDNA derived) 90/586
Interleukin-6 (Human, rDNA derived) 89/548
Interleukin-6 (Mouse, rDNA derived) 93/730
Interleukin-7 (Human, rDNA derived) 90/530
Interleukin-7 (Mouse, rDNA derived) 93/740
Interleukin-8 (Human, rDNA derived) 89/520
Interleukin-9 (Human,rDNA derived) 91/678
Islet Cell Antibodies 97/550
IVIG + anti-D for use with negative control IVIG 02/228
IVIG + Anti-D for use with negative control IVIG 04/132
IVIG and Anti-A and Anti-B Limit reference preparation 07/310
IVIG Negative Control for use with IVIG & Anti-D 04/140
IVIG negative control for use with IVIG + anti-D 02/226
IVIG, Anti-D and Negative Control Panel 05/242
Keratinocyte growth factor (KGF, FGF-7)(24-163) 03/148
Keratinocyte Growth Factor (KGF,FGF-7) 03/150
Kininogenase, Porcine 78/543
Leptin, Human, Recombinant 97/594
Leptin, Mouse, Recombinant 97/626
Leukaemia Inhibitory Factor (Human, rDNA derived) 93/562
Long-acting Thyroid Stimulator, Human 65/122
Low Molecular Weight Heparin for Molecular Weight Calibration(2nd International Standard) 05/112
Low Molecular Weight Heparin, 2nd International Standard 01/608
Lupus Anticoagulant Negative Control 96/522
Luteinizing Hormone, Bovine 98/566
Luteinizing Hormone, Human, Pituitary 80/552
Luteinizing Hormone, Human, recombinant 96/602
Luteinizing Hormone, Pituitary, alpha subunit 78/554
Luteinizing Hormone, Pituitary, beta subunit 78/556
Lysine Vasopressin 77/512
Lysine Vasopressin, Porcine 62/014
Macrophage Colony Stimulating Factor (CSF-1) (Human rDNA derived) 89/512
Macrophage Inflammatory Protein-1 alpha (Human, rDNA derived) 92/518
Mannan (C. Albians) Purified 76/515
Mannan (C. Albicans) Purified 77/600
MAPREC analysis of Poliovirus type 2 (Sabin) Synthetic DNA 0.67%481-G 97/758
MAPREC analysis of Poliovirus type 2 (Sabin) Synthetic DNA, 100%481-G 98/524
MAPREC analysis of Poliovirus type 2 (Sabin), high virus reference 1.21% 481-G 98/596
MAPREC analysis of Poliovirus type 2 (Sabin), low virus reference 0.65%481-G 97/756
MAPREC analysis of Poliovirus type 3 (Sabin) High virus reference 1.1%472-C 96/578
MAPREC analysis of Poliovirus type 3 (Sabin) Low virus reference 0.7%472-C 96/572
MAPREC analysis of Poliovirus type 3 (Sabin) Synthetic DNA 0.9% 472-C 95/542
MAPREC analysis of Poliovirus type 3 (Sabin). Synthetic DNA 100% 472-C 94/790
Measles Vaccine (Live) 92/648
Meningoccoccal Group C Polysaccharide 07/318
Meningococcal group A polysaccharide 98/722
Meningococcal group W135 polysaccharide 01/428
Meningococcal group Y polysaccharide 01/426
Methylated Human Serum Albumin (mHSA) 99/592
Monocyte Chemoattractant Protein-1 (Human,rDNA derived) 92/794
Multiplex Working Reagent (HCV, HBV, HAV, HIV, B19) 99/732
Mumps Vaccine (Live) 90/534
Negative Control for FCXM 02/282
Nerve Growth Factor (Human, rDNA derived) 93/556
Neurotrophin 3 98/718
Newcastle Disease Vaccine (Inactivated) NVIA
Oncostatin M (Human, rDNA derived) 93/564
Opacity 5IRP 76/522
Oxytocin 76/575
Papain preparation for use with Anti-D preparation 91/562 92/658
Parathyroid hormone 1-34 Recombinant, Human 04/200
Parathyroid Hormone, Bovine 76/572
Parathyroid Hormone, Bovine 82/632
Parathyroid Hormone, Bovine-Type, Synthetic (1-34) fragment 82/512
Parathyroid Hormone, Human 75/549
Parathyroid Hormone, Human 79/500
Parathyroid Hormone, Human 95/646
Parathyroid Hormone, Human-Type, Synthetic (1-34) fragment 82/508
Parvovirus B19 DNA Working reagent 99/736
Pertussis Antiserum (Human) 1st WHO Reference Reagent 06/142
Pertussis Antiserum (human)1st IS - WHO international Standard. 06/140
Pertussis Vaccine Whole Cell 94/532
Placental Lactogen, Human 73/545
Plasmin, Human 97/536
Plasminogen Activator Inhibitor-1 (PAI-1), plasma Human 92/654
Plasmodium falciparum DNA for NAT Assays 04/176
Platelet Factor 4 Human, Purified 83/505
Platelet-derived Growth Factor-BB (Human, rDNA derived) 94/728
Polio Virus Sabin Types 1, 2 and 3 02/306
Poliomyelitis Vaccine (Inactivated) 91/574
Positive control for FCXM 07/214
Prekallikrein Activator (PKA), Human 02/168
Prekallikrein Activator (PKA), Human 79/572
Primary Biliary Cirrhosis Serum, Human 67/183
Proinsulin, Bovine 84/514
Proinsulin, Human 84/611
Proinsulin, Porcine 84/528
Prolactin Human, recombinant, glycosylated 98/580
Prolactin, Human 83/573
Prolactin, Human 84/500
Prolactin, Human, recombinant 97/714
Prolactin, Human, recombinant, non-glycosylated 98/582
Prostate Specific Antigen (90:10) 96/670
Prostate Specific Antigen (free) 96/668
Protein C Concentrate, Human 04/252
Protein C Plasma 02/342
Protein S, Plasma, Human 03/228
Prothrombin Mutation G20210A, Human gDNA, 1st International Genetic Reference Panel 2005 05/130
Purified Protein Derivative (PPD) of Bovine Tuberculin PPDBOV
Purified Protein Derivative (PPD) of M Avium Tuberculin PPDA
Purified Protein Derivative (PPD) of M. Tuberculosis Tuberculin PPDT
Rabies vaccine 07/162
Rantes (Human, rDNA derived) 92/520
Renin, Human 68/356
Renin, Human, rec DNA 89/544
Renin, Porcine 65/119
Rheumatoid Arthritis Serum 64/002
Rheumatoid Arthritis serum. W1066
Rubella Vaccine (Live) 91/688
Secretin 77/643
Serum amyloid A protein 92/680
Serum Gonadotrophin, Equine 62/001
Serum Immunoglobulin E (IgE) Human 75/502
Serum Proteins (Other than Immunoglobulins) Human 74/520
Sex Hormone Binding Globulin (SHBG) 95/560
Short Ragweed Pollen Extract 84/581
Single Chain Urinary-Type Plasminogen Activator (SCuPA), (Glyc) 95/668
Single Chain Urinary-Type Plasminogen Activator (SCuPA), (Non-Glyc) 95/564
Smallpox Vaccine SMV
Soluble Tumor Necrosis Receptor factor Type II (Human, rDNA derived) 93/524
Soluble Tumour Necrosis Factor Receptor Type 1, (Human, rDNA derived) 96/528
Somatropin 98/574
Staphylococcus alpha antitoxin, Equine 63/020
Staphylococcus Alpha Antitoxin, Equine STA
Stem Cell Factor (Human rDNA derived) 91/682
Straphylokinase, rec (STAR) 94/718
Streptokinase 00/464
Streptokinase and Streptodornase 62/007
Swine Erysipelas Serum (anti-N) SES
Tetanus Antitoxin, Equine, for Bioassay 60/013
Tetanus Antitoxin, Equine, for Flocculation Test 66/021
Tetanus Antitoxin, Human, Immunoglobulin 76/589
Tetanus Immunoglobulin, Human TE-3
Tetanus Toxoid Adsorbed 98/552
Tetanus Toxoid For Flocculation Test 04/150
Tetanus Toxoid Not Adsorbed 02/232
Tetracosactide 80/590
Thrombin, human, 2nd International Standard 01/580
Thromboplastin, human, recombinant, plain (pack of 5 x W1054. use with reconstitution fluid rTF/95 RF) RTF/95
Thromboplastin,rabbit,plain(pack of 5 ampoules with diluent(04/210) RBT/05
Thrombopoietin, human rDNA derived 03/124
Thyroid Stimulating Hormone beta subunit 85/522
Thyroid Stimulating Hormone, Human 00/504
Thyroid Stimulating Hormone, Human 81/565
Thyroid Stimulating Hormone, Human recombinant 94/674
Thyroid Stimulating Hormone, recombinant 03/192
Thyroxine-binding globulin 88/638
Timothy Pollen Extract 82/520
Tissue Plasminogen Activator (tPA) Antigen in Plasma 94/730
Tissue Plasminogen Activator, Human, Recombinant 98/714
TNF-related Apoptosis-Inducing Ligand (trail), Human, rDNA-derived 04/166
Transforming Growth Factor beta-1 (Bovine) 89/516
Transforming Growth Factor beta-1 (Human, rDNA derived) 89/514
Transforming Growth Factor beta-2 (Bovine) 89/518
Transforming Growth Factor beta-2, Human, rec DNA 90/696
Transforming Growth Factor beta-3 (Human, rDNA derived) 98/608
Tuberculin, Old TU
Tumour Necrosis Factor alpha (Human Natural) 88/786
Tumour Necrosis Factor alpha (Mouse, rDNA derived) 88/532
Tumour Necrosis Factor beta (Human, rDNA derived) 87/640
Twelve Grass Pollen Extract 77/616
Typhoid Vaccine (acetone-inactivated) TYVK
Typhoid Vaccine (heat-phenol-inactivated) TYVL
Tyrophagus Longior Extract 78/582
Tyrophagus Putrescentiae Extract 78/517
Urokinase, High Molecular Weight 87/594
Vascular Endothelial Growth Factor 02/286
Vascular Endothelial Growth Factor, Human rDNA derived 01/424
Vitamin B12, Serum Folate 03/178
Von Willebrand factor, Concentrate 00/514
Yellow Fever Vaccine 99/616 


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发表于 2013-3-28 20:38 | 显示全部楼层
英国国家生物制品检定所,很多标准品这买的还是记不住这个名字
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