The National Institute for Biological Standards and Control (NIBSC) is a leading public institution under the UK Health Security Agency and serves as a major international center for biological standardization and quality control. NIBSC plays a central role in developing, storing, and distributing WHO International Standards and other biological reference materials used to support the safety, efficacy, and consistency of vaccines, blood products, diagnostics, biotherapeutics, and advanced therapies worldwide. As a leading WHO Collaborating Centre and International Laboratory for Biological Standards, NIBSC also supports global responses to public health needs through reference materials, quality control reagents, and scientific standardization programs. 

■ Product Portfolio

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●Vaccine-Related Standards

NIBSC provides vaccine-related standards and reference reagents covering a wide range of viral and bacterial vaccines. Its portfolio includes standards used for vaccine potency, antigen content, assay calibration, and quality control, with well-established work in influenza, polio, HPV, hepatitis B, and other vaccine areas. NIBSC also develops and supplies SARS-CoV-2-related materials, including RNA and antibody standards that support assay standardization, serology, and vaccine evaluation. 

☉Viral Vaccines: Standards and reference materials are available for viral vaccine applications such as influenza, poliomyelitis, measles, rubella, hepatitis B, HPV, and related areas of vaccine control and standardization. These materials are used in potency assessment, antigen characterization, and laboratory assay harmonization. 

☉Bacterial Vaccines: NIBSC also supports bacterial vaccine standardization, including materials relevant to DTP-type vaccines, meningococcal vaccines, pneumococcal vaccines, and related biological reference needs for vaccine development and control. 

☉COVID-19 Related Standards: The COVID-19-related portfolio includes SARS-CoV-2 RNA standards, antibody standards for serology standardization, and reference materials that support assay qualification, response monitoring, and vaccine evaluation. 

●Blood Products and Coagulation Factors

NIBSC supplies international standards and reference materials for blood products, coagulation factors, and transfusion safety. These materials are used to standardize assays for clotting factor activity, plasma-derived products, and blood-borne pathogen testing, helping ensure reliability in therapeutic and diagnostic settings. 

☉Coagulation Factors: NIBSC provides activity standards for coagulation-related products such as factor VIII, factor IX, and von Willebrand factor, supporting haemostasis testing and therapies used in conditions such as haemophilia. 

☉Plasma-Derived Products: Its standards also cover plasma-derived materials such as immunoglobulins, antithrombin, fibrinogen, and related biological products used in clinical and manufacturing settings. 

☉Transfusion Safety: NIBSC develops standards and reference materials for blood-borne pathogen testing, including HIV, hepatitis B, and hepatitis C, to support transfusion safety and plasma pool testing. 

●Therapeutic Biologics

NIBSC provides standards and reference materials for therapeutic biologics, including monoclonal antibodies, cytokines, growth factors, and advanced therapy products. These materials are used to support biological activity assessment, assay calibration, comparability studies, and quality control for established and emerging biologic therapies. 

☉Monoclonal Antibodies: The therapeutic biologics portfolio includes monoclonal antibody standards such as materials for infliximab, adalimumab, bevacizumab, and trastuzumab, supporting bioactivity and assay standardization. 

☉Cell and Gene Therapy Products: NIBSC is also active in advanced therapies, including quality-related reference materials and standardization support for stem cell- and gene therapy-related applications. 

☉Growth Factors and Cytokines: Reference materials are available for biologically active molecules such as erythropoietin, interferons, interleukins, and related therapeutic proteins used in assay calibration and quality control. 

●Diagnostic and Testing Standards

NIBSC offers standards and reference reagents for diagnostic testing, especially for infectious disease detection by molecular and serological methods. These materials are used as higher-order standards, assay calibrators, and external run controls for sensitive and specific diagnostic workflows. 

☉Infectious Disease Diagnostics: The infectious disease diagnostics portfolio includes nucleic acid and antibody-related standards for pathogens such as HIV, HPV, Zika virus, tuberculosis, hepatitis viruses, and other clinically important infectious agents. 

☉Autoimmunity and Allergy: NIBSC also supports diagnostic standardization in immune-related testing through selected reference reagents and control materials relevant to autoimmune and allergy assay development and evaluation. 

●Emerging Areas

NIBSC continues to support new and rapidly developing therapeutic and analytical fields through biological reference materials and standardization programs. Its work in advanced therapies, biosimilar-related standardization, and novel measurement science reflects its broader role in supporting future regulatory and research needs. 

☉Gene Editing: NIBSC is involved in advanced and emerging biologics standardization, which includes support for next-generation technologies relevant to genome engineering and novel therapeutic platforms. 

☉Biosimilars: NIBSC also provides reference materials relevant to biosimilar evaluation and comparability, helping support assay harmonization against originator biologics and related product assessment frameworks. 

■ Product List