WHO Expert Committee on Biological Standardization

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1 This report presents the recommendations of a WHO expert committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, sets out revised WHO Guidelines on the quality, safety and efficacy of candidate dengue tetravalent vaccines (live, attenuated), along with revised WHO Recommendations in relation to the production and quality control of bacille Calmette Guérin (BCG) vaccines and of acellular pertussis vaccines. In addition, a generic protocol for the calibration of seasonal and pandemic influenza antigen working reagents is included. Revised WHO Guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists are then presented. Finally, new WHO assessment criteria for national blood regulatory systems are provided. Subsequent sections of the report then provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1), followed by a series of WHO Recommendations and Guidelines adopted on the advice of the Committee (Annexes 2 7). All additions made during the meeting to the list of International Standards and Reference Reagents for biological substances maintained by WHO are then summarized in Annex 8, and are also available at: who.int/biologicals. 979 WHO Expert Committee on Biological Standardization WHO Technical Report Series W H O Sixty-second report T e c h n i c a l R e p o r t S e r i e s WHO Expert Committee on Biological Standardization 979

2 The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHO s constitutional functions is to provide objective and reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications. The Organization seeks through its publications to support national health strategies and address the most pressing public health concerns of populations around the world. To respond to the needs of Member States at all levels of development, WHO publishes practical manuals, handbooks and training material for specific categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and state-of-the-art consensus reports that offer technical advice and recommendations for decision-makers. These books are closely tied to the Organization's priority activities, encompassing disease prevention and control, the development of equitable health systems based on primary health care, and health promotion for individuals and communities. Progress towards better health for all also demands the global dissemination and exchange of information that draws on the knowledge and experience of all WHO s Member countries and the collaboration of world leaders in public health and the biomedical sciences. To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its publications and encourages their translation and adaptation. By helping to promote and protect health and prevent and control disease throughout the world, WHO s books contribute to achieving the Organization s principal objective the attainment by all people of the highest possible level of health. The WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated policy of WHO. For further information, please contact: WHO Press, World Health Organization, 20 avenue Appia, 1211 Geneva 27, Switzerland (tel ; fax: ; order online: SELECTED WHO PUBLICATIONS OF RELATED INTEREST WHO Expert Committee on Biological Standardization Sixty-first report. WHO Technical Report Series, No. 978, 2013 (xi pages) web site WHO Expert Committee on Biological Standardization Sixtieth report. WHO Technical Report Series, No. 977, 2013 (viii pages) WHO Expert Committee on Biological Standardization Fifty-ninth report. WHO Technical Report Series, No. 964, 2012 (viii pages) WHO Expert Committee on Biological Standardization Fifty-eighth report. WHO Technical Report Series, No. 963, 2011 (viii pages) WHO Expert Committee on Biological Standardization Fifty-seventh report. WHO Technical Report Series, No. 962, 2011 (viii pages) Further information on these and other WHO publications can be obtained from WHO Press, World Health Organization, 1211 Geneva 27, Switzerland (tel.: ; fax: ; order online:

3 W H O Tech n i c a l R e p o r t S e r i e s WHO Expert Committee on Biological Standardization Sixty-second report This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization

4 WHO Library Cataloguing-in-Publication Data WHO Expert Committee on Biological Standardization, sixty-second report. (WHO technical report series ; no. 979) 1. Biological products - standards. 2. Vaccines - standards. 3. Reference standards. 4. Guidelines. I.World Health Organization. II.WHO Expert Committee on Biological Standardization (2011: Geneva, Switzerland). III.Series. ISBN (NLM classification: QW 800) ISBN (e-book) ISSN World Health Organization 2013 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: ; fax: ; Requests for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the policies of the World Health Organization. Printed in Italy

5 Contents Abbreviations xi 1. Introduction 1 2. General Current directions Strategic directions in biological standardization Vaccines and biological therapeutics: recent and planned activities in biological standardization Blood products and related in vitro diagnostics: recent and planned activities in biological standardization Reports Report of the WHO Blood Regulators Network Reports from international laboratories and WHO collaborating centres for biological standards Issues Scientific issues identified by users of WHO biological Reference Preparations Issues shared with the WHO Expert Committee on Specifications for Pharmaceutical Preparations International Recommendations, Guidelines and other matters related to the manufacture and quality control of biologicals Vaccines and related substances Guidelines on the quality, safety and efficacy of dengue tetravalent vaccines (live, attenuated) Recommendations to assure the quality, safety and efficacy of BCG vaccines Recommendations to assure the quality, safety and efficacy of acellular pertussis vaccines Assessing risk when a potential adventitious agent is found Calibration of seasonal and pandemic influenza antigen working reagents by WHO essential regulatory laboratories Proposed new projects for developing or updating written standards Blood products and related substances Guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists Assessment criteria for national blood regulatory systems International reference materials vaccines and related substances WHO International Standards and Reference Reagents vaccines and related substances First WHO International Standard for meningococcal serogroup C polysaccharide First WHO International Standard for anti-pneumococcal antibodies in serum Third WHO International Standard for trivalent inactivated polio vaccine Proposed new projects vaccines and related substances Replacement of the First WHO International Standard for antibody to influenza A virus subtype H1N1pdm 21 iii

6 4.3 Ongoing stability monitoring vaccines and related substances Inactivated hepatitis A vaccine Progress reports vaccines and related substances Characteristics of an improved potency assay for inactivated influenza vaccines Hepatitis B vaccine International reference materials blood products and related substances WHO International Standards and Reference Reagents blood products and related substances Assignment of a value for von Willebrand factor propeptide to the Sixth WHO International Standard for factor VIII/VWF plasma Third WHO International Standard for fibrinogen (plasma) First WHO International Reference Reagent for anti-human neutrophil antigen-1a antibody First WHO International Reference Reagents for blood group genotyping Revision of the instructions for use of the First WHO International Reference Repository for platelet transfusion relevant bacterial strains Apolipoprotein B Proposed new projects blood products and related substances Replacement of the Second WHO International Reference Preparation for serum IgE Replacement of the Third WHO International Standard for plasmin Haemoglobin A International reference materials in vitro diagnostic device reagents WHO International Standards and Reference Reagents in vitro diagnostic device reagents Third WHO International Standard for HIV-1 for NAT-based assays Third WHO International Standard for hepatitis B virus for NAT-based assays First WHO International Reference Panel for hepatitis B virus genotype for HBsAg assays Fourth WHO International Standard for hepatitis C virus for NAT-based assays First WHO International Standard for hepatitis E virus for NAT-based assays First WHO International Reference Standard for anti-trypanosoma cruzi antibodies First WHO International Standard for Epstein Barr virus for NAT-based assays Proposed new projects in vitro diagnostic device reagents Third Meeting of WHO Collaborating Centres for Biological Standards Replacement of the First WHO International Standard for hepatitis A virus for NAT-based assays Replacement WHO International Standard for hepatitis B e-antigen Replacement WHO International Standard for hepatitis B e-antibodies First WHO International Reference Panel for hepatitis E virus genotypes for NAT-based assays Replacement of the First WHO International Reference Panel for HIV-1 subtypes First WHO International Reference Panel for HIV-1 circulating recombinant forms 39 iv

7 6.3 Ongoing stability monitoring Prostate-specific antigen International reference materials biotherapeutics other than blood products WHO International Standards and Reference Reagents biotherapeutics other than blood products First WHO International Standard for transforming growth factor beta Proposed new projects biotherapeutics other than blood products Replacement of the First WHO International Standard for interleukin Replacement of the Second WHO International Standard for recombinant human erythropoietin Replacement of the Fourth WHO International Standard for urinary follicle-stimulating hormone and urinary luteinizing hormone Replacement of the Second WHO International Standard for luteinizing hormone (human, pituitary) International reference materials antibiotics WHO International Standards and Reference Reagents antibiotics Third WHO International Standard for dihydrostreptomycin Proposed new projects antibiotics Replacement of the First WHO International Standard for neomycin B Replacement of the Second WHO International Standard for neomycin 46 Annex 1 WHO Recommendations, Guidelines and other documents related to the manufacture and quality control of biological substances used in medicine 47 Annex 2 Guidelines on the quality, safety and efficacy of dengue tetravalent vaccines (live, attenuated) 53 Annex 3 Recommendations to assure the quality, safety and efficacy of BCG vaccines 137 Annex 4 Recommendations to assure the quality, safety and efficacy of acellular pertussis vaccines 187 Annex 5 Generic protocol for the calibration of seasonal and pandemic influenza antigen working reagents by WHO essential regulatory laboratories 261 Annex 6 Guidelines for thromboplastins and plasma used to control oral anticoagulant therapy with vitamin K antagonists 271 Annex 7 Assessment criteria for national blood regulatory systems 317 Annex 8 Biological substances: WHO International Standards and Reference Reagents 365 v

8 WHO Expert Committee on Biological Standardization Sixty-second report WHO Expert Committee on Biological Standardization 17 to 21 October 2011 Members 1 Dr J. Epstein, Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, United States of America (USA) Dr E. Griffiths, Director-General, Biologics and Genetic Therapies, Health Canada, Ottawa, Ontario, Canada (Chairman) Mrs T. Jivapaisarnpong, Director, Institute of Biological Products, Department of Medical Sciences, Ministry of Public Health, Bangkok, Thailand Dr H. Klein, Chief, Department of Transfusion Medicine, National Institutes of Health, Bethesda, MD, USA Dr P. Minor, Head, Division of Virology, National Institute for Biological Standards and Control, Potters Bar, England Dr F.M. Moftah, Director-General, National Blood Transfusion Service, Ministry of Health, Giza, Egypt Dr J. Petricciani, Palm Springs, CA, USA (Rapporteur) Dr L.S. Slamet, 2 Deputy for Therapeutic Products, Narcotic, Psychotropic and Addictive Substance Control, Directorate General of Food and Drug Control of the Republic of Indonesia, Jakarta, Indonesia Dr P. Strengers, Medical Director, Division of Plasma Products, Sanquin, Amsterdam, the Netherlands Professor H. Yin, Deputy Director, Center for Drug Evaluation, State Food and Drug Administration, Beijing, China WHO Technical Report Series, No. 979, 2013 Representatives of other organizations Chinese Pharmacopoeia Commission Dr X. Hong, Biologics Division, Chinese Pharmacopoeia Commission, Beijing, China Council of Europe, European Department for the Quality of Medicines & Healthcare Dr K.H. Buchheit, Department of Biological Standardisation, OMCL Network and HealthCare, Strasbourg, France 1 The decisions of the Committee were taken in closed session with only members of the Committee present. Each Committee member had completed a declaration of interests form prior to the meeting. These were assessed by the WHO Secretariat and no declared interests were considered to be a conflict for full participation in the meeting. 2 Unable to attend. vi

9 WHO Expert Committee on Biological Standardization Dr E. Charton, Department of Biological Standardisation, OMCL Network and HealthCare, Strasbourg, France Developing Country Vaccine Manufacturers Network Dr S. Jadhav, Executive Director, Quality Assurance & Regulatory Affairs, Serum Institute of India Limited, Pune, India European Diagnostic Manufacturers Association Mrs C. Betremieux, Scientific Affairs Manager, Immuno Hematology Division, Bio-Rad Laboratories, Cressier, Switzerland European Medicines Agency Dr N. Gate, Principal Scientist, European Medicines Agency, London, England International Alliance of Biologicals Professor J. Löwer, International Alliance of Biologicals, Dreieich, Germany International Federation of Clinical Chemistry and Laboratory Medicine Professor P. Gillery, Vice-chair, IFCC Scientific Division, Reims, France International Federation of Pharmaceutical Manufacturers Associations Dr A. Sabouraud, Head of Pharmaceutical Affairs & Responsible Pharmacist, Sanofi Pasteur SA, Marcy l'étoile, France Dr C. Saillez, Senior Manager, Worldwide Vaccine Registration, GlaxoSmithKline Biologicals, Wavre, Belgium International Society of Blood Transfusion Dr G. Daniels, ISBT Secretary General, Head of Molecular Diagnostics, Bristol Institute for Transfusion Science & IBGRL, National Health Service Blood and Transplant, Bristol, England International Society on Thrombosis and Haemostasis Professor K. Mertens, Head, Department of Plasma Proteins, Sanquin Research, Amsterdam, the Netherlands Plasma Protein Therapeutics Association Dr I. von Hoegen, Senior Director, Quality and Safety, PPTA Europe, Brussels, Belgium United States Pharmacopeia Dr T.S. Morris, Vice President, Biologics and Biotechnology, United States Pharmacopeial Convention, Rockville, MD, USA Secretariat Dr A.S. Alquezar, National Program of Quality Control in the Brazilian Society of Clinical Laboratories, Rio de Janeiro, Brazil (Temporary Adviser) Dr M. Baca-Estrada, Chief, Bacterial and Combination Vaccines Division, Health Canada, Ottawa, Ontario, Canada (Temporary Adviser) vii

10 WHO Expert Committee on Biological Standardization Sixty-second report WHO Technical Report Series, No. 979, 2013 viii Professor A.D.T. Barrett, Director, Sealy Center for Vaccine Development, University of Texas Medical Branch, Galveston, TX, USA (Temporary Adviser) Dr D.A. Bleijs, Policy Officer, Expertise Centre for Substances, National Institute for Public Health and the Environment, Bilthoven, the Netherlands (Temporary Adviser) Dr A. Bristow, Head, Technology Development and Infrastructure, National Institute for Biological Standards and Control, Potters Bar, England (Temporary Adviser) Dr M. Chudy, Division of Virology, Paul-Ehrlich-Institute, Langen, Germany (Temporary Adviser) Professor K. Cichutek, President, Paul-Ehrlich-Institute, Langen, Germany (Temporary Adviser) Dr P.A. Diop, Director, Department of Pharmacy and Medicines, Ministry of Health and Medical Prevention, Dakar, Senegal (Temporary Adviser) Dr S. Fakhrzadeh, Senior Expert, Vaccine Office, Pharmaceutical & Narcotic Affairs Division, Food and Drug Organization, Ministry of Health & Medical Education of the Islamic Republic of Iran, Tehran, Islamic Republic of Iran (Temporary Adviser) Dr P. Ganz, Director, Centre for Blood and Tissues Evaluation, Health Canada, Ottawa, Ontario, Canada (Temporary Adviser) Dr I. Hamaguchi, Director, Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, Tokyo, Japan (Temporary Adviser) Dr K. Haslov, Vice President, Vaccine Quality Control, Statens Serum Institute, Copenhagen, Denmark (Temporary Adviser) Dr M. Heiden, Haematology and Transfusion Medicine, Paul-Erhlich-Institute, Langen, Germany (Temporary Adviser) Dr M.M. Ho, Division of Bacteriology, National Institute for Biological Standards and Control, Potters Bar, England (Temporary Adviser) Dr A. Hubbard, Division of Haematology, National Institute for Biological Standards and Control, Potters Bar, England (Temporary Adviser) Dr S. Inglis, Director, National Institute for Biological Standards and Control, Potters Bar, England (Temporary Adviser) Dr H. Jung Oh, Senior Scientific Officer and Reviewer, Biopharmaceuticals and Herbal Medicine Evaluation Department, Korea Food and Drug Administration, Chungcheongbuk-do, Republic of Korea (Temporary Adviser) Dr M. Jutzi, Clinical Reviewer Haemovigilance, Swissmedic, Berne, Switzerland (Temporary Adviser) Dr A. Kato, Chief, Department of Virology III, National Institute of Infectious Diseases, Tokyo, Japan (Temporary Adviser)

11 WHO Expert Committee on Biological Standardization Dr I. Knezevic, Team Leader, Essential Medicines and Pharmaceutical Policies, WHO, Geneva, Switzerland Dr K.M. Lee, Senior Scientific Officer, Biologics Research Division, Korea Food and Drug Administration, Seoul, Republic of Korea (Temporary Adviser) Dr L. Markoff, 3 Laboratory Chief, Division of Virology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD, USA (Temporary Adviser) Dr B. Meade, Consultant, Meade Biologics, Hillsborough, NC, USA (Temporary Adviser) Dr N.E. Metwalli, Medical Officer, Blood Safety, Laboratory & Imaging, WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt Dr G. Michaud, Deputy Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA (Temporary Adviser) Dr T. Montag-Lessing, 3 Head, Section of Microbial Safety, Paul-Ehrlich-Institute, Langen, Germany (Temporary Adviser) Dr S. Morgeaux, Head of Viral Control Unit, Agence Française de Sécurité Sanitaire des Produits de Santé, Direction des Laboratoires et des Contrôles, Lyons, France (Temporary Adviser) Dr C. Morris, Division of Retrovirology, National Institute for Biological Standards and Control, Potters Bar, England (Temporary Adviser) Dr M. Nübling, Division of Virology, Paul-Ehrlich-Institute, Langen, Germany (Temporary Adviser) Dr M. Ochiai, Senior Research Scientist, Division of Quality Assurance, National Institute of Infectious Diseases, Tokyo, Japan (Temporary Adviser) Dr V. Oeppling, Head of Section for Microbiological Vaccines, Paul-Ehrlich-Institute, Langen, Germany (Temporary Adviser) Dr M. Otani, Quality Control Department, Fundaçao Pró Sangue Hemocentro de São Paulo, São Paulo, Brazil (Temporary Adviser) Dr A.M. Padilla Marroquin, Scientist, Quality Assurance and Safety: Medicines, WHO, Geneva, Switzerland Dr M. Powell, Medicines and Healthcare Products Regulatory Agency, London, England (Temporary Adviser) Dr I. Sainte-Marie, Department for Evaluation of Biological Products, Saint Denis, France (Temporary Adviser) 3 For specific agenda items only by telephone. ix

12 WHO Expert Committee on Biological Standardization Sixty-second report WHO Technical Report Series, No. 979, 2013 Professor R. Seitz, Head, Division of Haematology and Transfusion Medicine, Paul-Ehrlich- Institute, Langen, Germany (Temporary Adviser) Mr S. Shani, Deputy Drugs Controller, Central Drugs Standard Control Organization, Under Directorate General of Health Services, Ministry of Health & Family Welfare, New Delhi, India (Temporary Adviser) Dr G. Smith, Director, Blood and Tissues Unit, Therapeutic Goods Administration, Woden, Australia (Temporary Adviser) Dr Y. Sohn, Director General, Biopharmaceuticals and Herbal Medicine Evaluation Department, Korea Food and Drug Administration, Chungcheongbuk-do, Republic of Korea (Temporary Adviser) Dr J. Southern, Adviser to Medicines Control Council of South Africa, Ministry of Health, Cape Town, South Africa (Temporary Adviser) Dr R. Thorpe, Division of Immunobiology, National Institute for Biological Standards and Control, Potters Bar, England (Temporary Adviser) Dr D.W. Trent, Director, Regulatory and Scientific Affairs, Office of Regulated Nonclinical Studies, The University of Texas Medical Branch, Galveston, TX, USA (Temporary Adviser) Dr A.M.H.P. van den Besselaar, Department of Thrombosis and Haemostasis, University of Leiden, Leiden, the Netherlands (Temporary Adviser) Professor G.N. Vyas, Professor Laboratory Medicine, University of California, San Francisco, CA, USA (Temporary Adviser) Dr J. Wang, Deputy Director, National Institutes of Food and Drug Control, Beijing, China (Temporary Adviser) Dr J. Weir, Director, Division of Viral Products in the Office of Vaccines, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, USA (Temporary Adviser) Dr D. Wood, Coordinator, Quality, Safety and Standards, Essential Medicines and Health Products, WHO, Geneva, Switzerland (Secretary) Dr D. Xing, Principal Scientist, Bacteriology Division, National Institute for Biological Standards and Control, Potters Bar, England (Temporary Adviser) Dr N. Yasuda, International Planning Director, Ministry of Health, Labour and Welfare, c/o Pharmaceutical Affairs Bureau, Tokyo, Japan (Temporary Adviser) Dr S. Zhang, Director, Division of Biological Products, State Food and Drug Administration, Beijing, China (Temporary Adviser) Dr K. Zoon, Director, Division of Intramural Research, NIAID, National Institutes of Health, Bethesda, MD, USA (Temporary Adviser) x

13 Abbreviations Ae Aedes AE adverse event AR adverse reaction BCG bacille Calmette Guérin vaccine BRN Blood Regulators Network CBER Center for Biologics Evaluation and Research CCID 50 cell culture infectious dose 50% CDC Centers for Disease Control and Prevention CFU colony-forming units CMI cell-mediated immunity DENV dengue virus DFI dengue febrile illness DTaP acellular pertussis component DTP vaccine DTP diphtheria, tetanus and pertussis E envelope EDQM European Directorate for Quality of Medicines and HealthCare ELISA enzyme-linked immunosorbent assay ERA environmental risk assessment FDA United States Food and Drug Administration FSH follicle-stimulating hormone GCP good clinical practice GCV geometric coefficient of variation GDP good distribution practice GMO genetically modified organism GMP good manufacturing practices HBsAg hepatitis B surface antigen HAV hepatitis A virus HBV hepatitis B virus xi

14 WHO Expert Committee on Biological Standardization Sixty-second report WHO Technical Report Series, No. 979, 2013 xii HCV HEV HPLC ICDRA IPV ISBT ISTH IU LH MHLW NAT NCL NIAID NIBSC NRA NS OPV PCR PDK PEI prm PRNT RT-PCR QMS SOP SPC SSC TSE TSH hepatitis C virus hepatitis E virus high-performance liquid chromatography International Conference of Drug Regulatory Authorities inactivated polio vaccine International Society of Blood Transfusion International Society on Thrombosis and Haemostasis International Unit luteinizing hormone Ministry of Health, Labour and Welfare, Japan nucleic acid amplification technique national control laboratory National Institute of Allergy and Infectious Diseases National Institute for Biological Standards and Control national regulatory authority non-structural oral polio vaccine polymerase chain reaction primary dog kidney Paul-Ehrlich-Institute premembrane plaque-reduction neutralization test reverse transcription-polymerase chain reaction quality management system standard operating procedure summary of product characteristics Scientific and Standardisation Subcommittee (ISTH) transmissible spongiform encephalopathy thyroid-stimulating hormone

15 Abbreviations UTR VE VWF VWF:Ag VWFpp WHA YFV untranslated region vaccine efficacy von Willebrand factor von Willebrand factor antigen von Willebrand factor propeptide World Health Assembly yellow fever virus xiii

16

17 1. Introduction The WHO Expert Committee on Biological Standardization met in Geneva from 17 to 21 October The meeting was opened on behalf of the Director- General by Dr Carissa Etienne, Assistant Director-General of the Health Systems and Services cluster. Dr Etienne outlined the major issues to be discussed during the meeting. A major need in many developing countries is for guidance on the safety of blood products, especially in relation to strengthening national and regional blood regulatory systems. The Committee would also be requested to provide advice on diagnostics for Chagas disease, and on hepatitis B viral genotype diagnostics. Dr Etienne also emphasized the importance of WHO reference materials in improving and ensuring access to quality biological products. She noted that a record number of new and replacement vaccines would become available in the coming years and would be presented for adoption during future meetings, with guidelines on dengue vaccines and bacille Calmette Guérin (BCG) vaccines, for example, being put forward for consideration at the current meeting. She reiterated that a major goal of WHO was to assure the availability of safe, effective and affordable vaccines, diagnostics, and reagents, and that this included capacitybuilding for regulatory authorities. Dr Etienne also told the Committee that the Decade of Vaccines initiative, endorsed by the World Health Assembly (WHA) in 2011, offered a unique opportunity for all involved sectors to work together to realize the full potential of vaccines in enhancing public health worldwide. Dr Etienne concluded by reminding the members of the Committee that they served as individual experts and not as representatives of their parent organizations or countries. She also reminded them that they should participate fully in the discussions so that maximum use could be made of their expertise and that the decisions reached should be based on sound scientific considerations. Dr Elwyn Griffiths was elected Chairman of both the overall meeting and vaccine track with Dr John Petricciani as Rapporteur, and Dr Harvey Klein was elected Chair of the blood track with Dr Anthony Hubbard and Dr Micha Nübling as Rapporteurs. The Committee then adopted the agenda (WHO/BS/ ) and the timetable proposed. 1

18 WHO Technical Report Series, No. 979, General 2.1 Current directions Strategic directions in biological standardization Dr David Wood informed the Committee that the International Conference of Drug Regulatory Authorities (ICDRA) recommended collaboration and cooperation with WHO in several areas, including: (a) continuing to assist national regulatory authorities (NRAs) in garnering political support at national or regional levels to build regulatory capacity; (b) providing a mechanism for sharing ongoing regional harmonization activities; (c) collecting best practices for collaboration and cooperation between NRAs including information exchange, joint assessments and inspections and activities aimed at reducing duplication; and (d) facilitating the twinning of less-developed agencies with well-established agencies for capacity-building and training. NRA strengthening was one of the top 10 priorities for WHO, and a range of initiatives had been or were being developed. The Committee was informed of the Decade of Vaccines initiative which aimed to enhance coordination across the global community by creating a global vaccine action plan (GVAP) with four working groups: (a) public and political support; (b) delivery; (c) research and development; and (d) global access. Groups b d incorporated regulatory aspects. Priorities in the short-, middle- and long-term were to be set and a regulatory research agenda was to be developed by the end of 2011 with broad input from interested parties. The Committee noted this development and supported proposals for WHO to lead a process of regulator engagement as part of the Decade of Vaccines initiative, and to further the development of a global regulatory research agenda. Consideration may be given to the potential for extending this approach to other areas of biologicals. In that regard, the Committee recommended that WHO obtain the views of various groups and committees involved with biologicals. The results of a survey undertaken by WHO showed that norms and standards were valued by both developed and developing countries. However, indicators were needed of the impact of WHO norms and standards in order to quantify their value to stakeholders. Survey participants also indicated that the process of priority-setting for new norms and standards should be made more transparent and inclusive. Other issues arising from the survey findings included the need for ongoing review of the continued fitness for purpose of Reference Preparations provided by WHO, and for the Committee to continue to meet at least once a year in order to provide up-to-date guidance to stakeholders. It was recognized that implementation programmes for complex standards were essential but were resource-intensive. WHO should therefore carefully evaluate the needs of stakeholders and set priorities appropriately. The need for efforts

19 General to increase the implementation of the standards adopted by the Committee should be more clearly highlighted as part of achieving improved international harmonization. Although there continued to be strong demand for the outcomes of WHO standardization activities, reforms were now under way to adjust the work of WHO in accordance with a new and constrained global economic reality. This would require WHO to re-evaluate its ability to maintain some of its current activities and to undertake new initiatives. Dr Wood also informed the Committee that Sanofi Pasteur had donated type-3 polio vaccine seed strain to WHO that would be held at the National Institute for Biological Standards and Control (NIBSC), Potters Bar, Herts, England Vaccines and biological therapeutics: recent and planned activities in biological standardization An important element of WHO biological standardization activities is to facilitate the implementation of WHO guidance in the regulation and control of product development and manufacturing. In this context, a joint meeting had been held with the International Alliance for Biological Standardization (IABS) to discuss the use of thermal stability data for vaccines. Additionally, steps were being taken to strengthen collaboration between WHO collaborating centres and NRAs. One aim was to ensure that such centres could assist countries in their respective regions, while promoting the implementation of WHO written standards and inter-laboratory collaboration. The adoption of a networking approach by WHO collaborating centres in this and other areas was seen as a potential aid to this process. Proposals were then set out to the Committee to make draft WHO guidelines and recommendations available for public comment in order to allow revision as necessary before final presentation to the Committee for adoption. This step was intended to help speed up adoption and to facilitate the inclusion of up-to-date scientific knowledge and best practices. WHO written standards for vaccines have evolved over the years to include technical specifications to help define safe and efficacious vaccines. These specifications are intended to be scientific and advisory in nature, and can be used as a starting point for setting national requirements and for vaccine prequalification. Proposed written standards for were reviewed for a range of specific products and activities, including oral polio vaccine (OPV); combined vaccines based on diphtheria, tetanus and pertussis (DTP) vaccine; malaria vaccine; Japanese encephalitis vaccine (live, attenuated); dengue vaccine; bacille Calmette Guérin (BCG) vaccine; acellular pertussis (ap) vaccine; inactivated polio vaccine (IPV); risk assessment activities; nonclinical evaluation; and biologicals derived by DNA technology. 3

20 WHO Expert Committee on Biological Standardization Sixty-second report WHO Technical Report Series, No. 979, Another important activity is the development of WHO guidance on the regulatory evaluation of copies of biological medicines that have come offpatent also known as similar biotherapeutic products (SBPs) or biosimilars based on sound scientific principles but without inhibiting the development and introduction of such products in a wider range of countries. A plan for the implementation of written standards in covered SBPs in China, and vaccine lot releases in Latvia and India. The development of guidance on SBPs in Latin America could also usefully be considered. A consultation on the strategic direction for standardization of vaccines and biotherapeutics was planned for April 2012 and a first meeting of a proposed network of WHO collaborating centres was planned immediately afterwards to discuss issues such as the role of WHO and other standard-setting bodies in developing standards, and establishing networks of NRAs and national control laboratories (NCLs). The Committee was also advised that feedback had been obtained from stakeholders concerning the biological standardization web site (http://www. who.int/biologicals) and improvements had been made as a result. Further changes would be incorporated as appropriate. The Committee was then reminded that WHO was in the process of reform which would result in decreased resources at a time when there were increasing expectations of assistance from countries. As a result, the Committee recommended that a review of the work of the WHO Quality, Safety and Standards unit be undertaken that should include the unit business plan, the WHO constitutional mandates, country expectations, workload, impact on global public health, priority-setting, and funding sources and opportunities. The Committee noted that throughout the course of the meeting, recommendations were made for such a review of the work of the unit which it strongly endorsed. The Committee noted the report of activities in this area and indicated its support for the proposal for WHO to provide technical support to countries on selected recently adopted written standards, and to develop impact indicators for this area of work. The Committee also recommended that WHO should consider the establishment of a process for formally numbering the different versions of written standards that were recommended by the Committee for adoption and published on the WHO web site prior to finalized publication in the WHO Technical Report Series. The Committee also recommended that in future more specific guidance should be provided by the WHO Quality, Safety and Standards unit regarding the degree of detail to be incorporated into the report of the decisions made by the Committee. The Committee considered this to be an important step in harmonizing the work of the current two meeting tracks on vaccine-related and blood-related materials.

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