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. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO Recommendations for evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products, for production and control of hepatitis B vaccines and for production and control of yellow fever vaccines. New WHO Guidelines on the independent lot release of vaccines are also included. Finally, there is an update to the procedure for the prequalification of vaccines. Also included are lists of Recommendations, Guidelines and other documents related to the manufacture and control of biological substances used in medicine, and of International Standards and Reference Reagents for biological substances. 978 WHO Expert Committee on Biological Standardization WHO Technical Report Series W H O Sixty-first 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 978

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 on line: SELECTED WHO PUBLICATIONS OF RELATED INTEREST WHO Expert Committee on Biological Standardization Sixtieth report. WHO Technical Report Series, No. 977, 2013 (viii pages) Web site: 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) WHO Expert Committee on Biological Standardization Fifty-sixth report. WHO Technical Report Series, No. 941, 2007 (x 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-first 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-first report. (WHO technical report series ; no. 978) 1. Biological products - standards. 2. Vaccines - standards. 3. Reference standards. 4. Guideline. I.World Health Organization. II.WHO Expert Committee on Biological Standardization (2010: Geneva, Switzerland). III.Series. ISBN (NLM classification: QW 800) ISSN World Health Organization 2013 All rights reserved. Publications of the World Health Organization are available on the WHO web site (http://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 x 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 WHO Blood Regulators Network Reports from the WHO international laboratories and 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 8 3. International Recommendations, Guidelines and other matters related to the manufacture and quality control of biologicals Vaccines and related substances Guidelines for independent lot release of vaccines by regulatory authorities Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks Recommendations to assure the quality, safety and efficacy of hepatitis B vaccines Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies Blood products and related substances GMP for blood establishments WHO tables on tissue infectivity distribution in TSEs Assessment criteria for national blood regulatory systems International reference materials vaccines and related substances WHO International Standards and Reference Reagents vaccines and related substances Antibody to vaccinia virus Antibody to pandemic H1N1 influenza virus Tetanus vaccine BCG vaccine Proposed new projects vaccines and related substances Diphtheria vaccine for calibration of formulated products by alternative to challenge assays (Vero cell assay) 20 iii

6 4.2.2 Hepatitis B vaccine BCG vaccine of Moreau substrain Ongoing stability monitoring vaccines and related substances Tetanus toxoid, flocculation International reference materials blood products and related substances WHO International Standards and Reference Reagents blood products and related substances Thrombosis and haemostasis Antithrombin, plasma Factors II, VII, IX and X, plasma von Willebrand factor, concentrate C1 inhibitor, plasma and C1 inhibitor, concentrate Proposed new projects blood products and related substances Factor II, X, concentrate Factor VII, concentrate von Willebrand factor propeptide (VWFpp) as a new analyte to be added to the WHO Sixth International Standard for factor VIII/ von Willebrand factor, plasma High molecular weight urokinase D-dimer, plasma PAI-1 antigen, plasma Transfusion-relevant bacterial strain panel International reference materials diagnostic reagents WHO International Standards and Reference Reagents diagnostic reagents Human cytomegalovirus (HCMV) for nucleic acid amplification technique (NAT)-based assays RHD/SRY plasma DNA Proposed new projects diagnostic reagents Hepatitis B virus DNA for NAT-based assays Hepatitis C virus RNA for NAT-based assays Human herpes virus 6 for NAT-based assays Adenovirus for NAT-based assays Detection of Mycoplasma: NAT-based assays Babesia antibody Chikungunya virus RNA for NAT-based assays Anti-HTLV I/II reference panel Plasmodium falciparum antibody reference panel International reference materials biotherapeutics (other than blood products) WHO International Standards and Reference Reagents biotherapeutics (other than blood products) Thyroid-stimulating antibody Follicle-stimulating hormone, human, recombinant, for bioassay Sex hormone-binding globulin Granulocyte colony-stimulating factor 36 iv

7 7.2 Proposed new projects biotherapeutics (other than blood products) WHO reference panel anti-erythropoietin antibodies testing Human proinsulin Human insulin C-peptide Proposed WHO First Reference Reagent for human interleukin CD4+ cell counting standard Ongoing stability monitoring biotherapeutics (other than blood products) Somatropin (recombinant human growth hormone) International reference materials antibiotics WHO International Standards and Reference Reagents antibiotics Vancomycin Proposed new projects antibiotics Dihydrostreptomycin 39 References 40 Annex 1 WHO Recommendations, Guidelines and other documents related to the manufacture and control of biological substances used in medicine 41 Annex 2 Guidelines for independent lot release of vaccines by regulatory authorities 47 Annex 3 Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks 79 Annex 4 Recommendations to assure the quality, safety and efficacy of recombinant hepatitis B vaccines 189 Annex 5 Recommendations to assure the quality, safety and efficacy of live attenuated yellow fever vaccines 241 Annex 6 Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies 315 Annex 7 Biological substances: International Standards and Reference Reagents 383 v

8 WHO Expert Committee on Biological Standardization Sixty-first report WHO Expert Committee on Biological Standardization 18 to 22 October 2010 Members 1 Dr M.M.F. Ahmed, National Organisation for Drug Control and Research (NODCAR), Agousa, Egypt Dr R. Dobbelaer, 2 Lokeren, Belgium Dr J. Epstein, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD, United States of America (USA) Dr E. Griffiths, Health Canada, Ontario, Canada (Chairman) Mrs T. Jivapaisarnpong, Division of Biological Products, Ministry of Public Health, Nonthaburi, Thailand (Vice-chairman) Dr H. Klein, National Institutes of Health, Bethesda, MD, USA Dr P. Minor, National Institute for Biological Standards and Control, Potters Bar, England Dr L.S. Slamet, National Agency of Drug and Food Control, Jakarta, Indonesia Dr P. Strengers, Sanquin, Amsterdam, the Netherlands Professor H. Yin, State Food and Drug Administration, Beijing, China WHO Technical Report Series, No. 978, 2013 Representatives from other organizations Council of Europe, European Directorate for the Quality of Medicines and HealthCare Dr K.H. Buchheit, OMCL Network and Health Care, Strasbourg, France Mr J-M. Speiser, OMCL Network and Health Care, Strasbourg, France Developing Country Vaccine Manufacturers' Network Dr M. Bhalgat, Biological E. Ltd, Hyderabad, India Mr P.V.V.S. Murthy, Biological E. Ltd, Hyderabad, India European Diagnostic Manufacturers Association Dr C. Giroud, Bio-Rad Laboratories, Marnes-la-Coquette, France European Medicines Agency Dr P. Richardson, London, England 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 European Society of Human Genetics Dr M. Morris, Centre médical universitaire, Geneva, Switzerland International Association of Biologicals Dr A. Mire-Sluis, Amgen Inc., Thousand Oaks, CA, USA International Federation of Clinical Chemistry and Laboratory Medicine Professor J-C. Forest, Québec, Canada International Federation of Pharmaceutical Manufacturers & Associations Dr M. Duchêne, GSK Biologicals, Wavre, Belgium Dr A. Sabouraud, Sanofi Pasteur, Marcy l'étoile, France Dr C. Saillez, GlaxoSmithKline Biologicals, Wavre, Belgium International Organization for Standardization Mr T. Hancox, Geneva, Switzerland International Plasma Fractionation Association Dr R. Perry, Amsterdam, the Netherlands International Society of Blood Transfusion Professor E. Zhiburt, Moscow, Russian Federation International Society on Thrombosis and Haemostasis Professor K. Mertens, Sanquin, Amsterdam, the Netherlands Plasma Protein Therapeutics Association Dr I. von Hoegen, Brussels, Belgium United States Pharmacopeia Dr T.S. Morris, Rockville, MD, USA Dr A. Szajek, Rockville, MD, USA Secretariat Dr J.W. Atkins, National Institutes of Health, Bethesda, MD, USA (Temporary Adviser) Professor A. Barrett, University of Texas Medical Branch at Galveston, TX, USA (Temporary Adviser) Professor D. Barton, Our Lady's Children's Hospital, Dublin, Ireland (Temporary Adviser) Mr A. Battersby, Somerset, England (Temporary Adviser) Dr V. Bogdanova, Federal Medico-Biological Agency (FMBA), Moscow, Russian Federation (Temporary Adviser) Dr T. Burnouf, Human Protein Process Sciences, Lille, France (Temporary Adviser) Professor K. Cichutek, Paul-Ehrlich-Institute, Langen, Germany (Temporary Adviser) Dr M. Ferguson, Norfolk, England (Temporary Adviser) vii

10 WHO Expert Committee on Biological Standardization Sixty-first report WHO Technical Report Series, No. 978, 2013 viii Dr P. Ganz, Biologics and Genetic Therapies Directorate, Health Canada, Ottawa, Canada (Temporary Adviser) Mr A. Garnett, London, England (Temporary Adviser) Ms L. Gomes Castanheira, Agencia Nacional da Vigilancia Sanitaria, Brasília DF, Brazil (Temporary Adviser) Dr A. Hubbard, National Institute for Biological Standards and Control, Potters Bar, England (Temporary Adviser) Dr S. Inglis, National Institute for Biological Standards and Control, Potters Bar, England (Temporary Adviser) Dr J. Joung, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Seoul, Republic of Korea (Temporary Adviser) Dr C. Milne, OMCL Networks and HealthCare (DBO), European Directorate for the Quality of Medicines and HealthCare (EDQM), Strasbourg, France (Temporary Adviser) Dr F. Moftah, Ministry of Health, Giza, Egypt (Temporary Adviser) Dr S. Morgeaux, Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), Lyons, France (Temporary Adviser) Dr P.R. Murray, National Institutes of Health, Bethesda, MD, USA (Temporary Adviser) Dr M. Nübling, Paul-Ehrlich-Institute, Langen, Germany (Temporary Adviser) Professor D.E. Onions, CSO BioReliance, Almancil, Portugal (Temporary Adviser) Dr H.J. Oh, Korea Food and Drug Administration, Seoul, Republic of Korea (Temporary Adviser) Dr J. Petricciani, Palm Springs, CA, USA (Temporary Adviser) Professor M. Pocchiari, Istituto Superiore di Sanita, Rome, Italy (Temporary Adviser) Dr I. Sainte Marie, Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), Saint Denis, France (Temporary Adviser) Dr C. Schärer, Swissmedic, Bern, Switzerland (Temporary Adviser) Professor R. Seitz, Paul-Ehrlich-Institute, Langen, Germany (Temporary Adviser) Dr S. Shani, Central Drugs Standard Control Organisation, New Delhi, India (Temporary Adviser) Dr R. Sheets, National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD, USA (Temporary Adviser) Dr G. Smith, TGA, Canberra, Australia (Temporary Adviser) Dr J. Southern, Ministry of Health, Cape Town, South Africa (Temporary Adviser) Dr M. Valdkhani, Ministry of Health and Medical Education of the Islamic Republic of Iran, Tehran, Islamic Republic of Iran (Temporary Adviser)

11 WHO Expert Committee on Biological Standardization Professor G.N. Vyas, University of California at San Francisco, San Francisco, CA, USA (Temporary Adviser) Dr J.Z. Wang, National Institute for the Control of Pharmaceutical and Biological Products, Beijing, China (Temporary Adviser) Dr H. Watanabe, National Institute of Infectious Diseases (NIID), Tokyo, Japan (Temporary Adviser) Dr D. Wood, World Health Organization, Geneva, Switzerland (Secretary) Dr K. Zoon, Director, NIAID, National Institutes of Health, Bethesda, MD, USA (Temporary Adviser; Rapporteur) ix

12 Abbreviations WHO Technical Report Series, No. 978, 2013 x BCG BRN BSP CBER cfu CMV DTP EDQM ELISA FDA FSH GCP G-CSF GCV GMP HBsAg HBV HCMV HCV HHV HI HPLC HTLV IL IPV ISBT ISTH IU bacille Calmette Guérin vaccine Blood Regulators Network Biological Standardisation Programme (EQDM) Center for Biologics Evaluation and Research colony-forming units cytomegalovirus diphtheria tetanus pertussis vaccine European Directorate for Quality of Medicines and Healthcare enzyme-linked immunosorbent assay United States Food and Drug Administration follicle-stimulating hormone good clinical practice granulocyte colony-stimulating factor geometric coefficient of variation good manufacturing practices hepatitis B surface antigen hepatitis B virus human cytomegalovirus hepatitis C virus human herpes virus haemagglutination inhibition high-pressure liquid chromatography human T-cell lymphotropic virus interleukin inactivated polio vaccine International Society of Blood Transfusion International Society on Thrombosis and Haemostasis International Unit

13 Abbreviations IVIG NAT NCL NIBSC NRA OPV PAI PCR PEI PRNT PrP rhfsh SHBG SSC TSAbs TSEs TSH UNICEF USA VN WP-TTID VWF VWFpp WHA WHO intravenous immunoglobulin nucleic acid amplification technique national control laboratory National Institute for Biological Standards and Control national regulatory authority oral polio vaccine plasminogen activator inhibitor polymerase chain reaction Paul-Ehrlich-Institute plaque reduction neutralization tests prion protein recombinant human follicle-stimulating hormone sex hormone-binding globulin Scientific and Standardisation Subcommittee (ISTH) thyroid-stimulating antibodies transmissible spongiform encephalopathies thyroid-stimulating hormone United Nations Children s Fund United States of America virus neutralization Transfusion-Transmitted Infectious Diseases Working Party von Willebrand factor von Willebrand factor propeptide World Health Assembly World Health Organization xi

14

15 1. Introduction The World Health Organization (WHO) Expert Committee on Biological Standardization met in Geneva from 18 to 22 October The meeting was opened on behalf of the Director-General by Dr Jean-Marie Okwo-bele, Director, Immunization, Vaccines and Biologicals. Dr Okwo-bele emphasized that evidence-based international norms and standards for biological products, developed through rigorous, transparent, inclusive and authoritative processes, provided a solid foundation upon which health systems could build to deliver products of assured quality to address important public health problems. He noted that the Committee was responsible for establishing such norms and standards and that the development of proposals to be considered at the current meeting involved extensive preparations, in some cases over several years leading up to the meeting. He pointed out that the decisions of the Committee would have important public health outcomes. For example, a revision to the vaccines prequalification procedure was proposed. Vaccine prequalification was a core activity of WHO, the primary purpose of which was to ensure that the vaccines purchased by United Nations procurement agencies would be consistently safe and effective under conditions of use for national immunization programmes. Approximately 64% of the total global infant population received prequalified vaccines. The prequalification process was described in a written procedure, which had last been updated in Since that time, the number and type of vaccines being offered for prequalification had become more diverse. Other challenges to the prequalification programme included the availability of new production technologies, multiple production sites and partnerships between manufacturers in developing and developed countries. The demand for prequalification evaluation had significantly increased and this trend was expected to continue and even to accelerate in the coming years. The proposed revised procedure was expected to be more efficient and more transparent. The immunization programmes in countries that were recipients of prequalified vaccines had voiced their expectation that quality would not be compromised in the revised process. Critical review from the Committee would be extremely important to meet these various expectations and to provide this assurance. Dr Okwo-bele also drew attention to the WHO Guidelines on tissue infectivity distribution in transmissible spongiform encephalopathies (1), which would be considered at the current meeting. These guidelines had last been published in They remained valid, but new information on the distribution of tissue infectivity was now available. It was thus important, in the context of potential transmission of variant Creutzfeldt Jakob disease through human blood and blood products, as well as through medicinal products prepared with bovinederived materials, that an update be considered. The Committee would consider 1

16 WHO Expert Committee on Biological Standardization Sixty-first report a proposal in which some tissues were moved from the category of tissues with no detectable infectivity to the category of lower-infectivity tissues. He noted that each of the documents considered by the Committee was intended to serve as a guide for national requirements. If a national regulatory authority (NRA) so desired, the guidelines could be adopted as definitive national requirements. As usual, the Committee would consider a number of proposed new or replacement global measurement standards. These were central to the regulatory process, as they defined the International Unit that is used for dosing purposes for many biological medicines. Dr Elwyn Griffiths was elected Chairman of the overall meeting, Mrs Teena Jivapaisarnpong as Vice-chairman and Dr Kathy Zoon as Rapporteur. The meeting was divided into parallel tracks. Dr Elwyn Griffiths was elected as Chairman, Mrs Teena Jivapaisarnpong as Vice-chairman and the WHO Secretariat as Rapporteur for the Vaccine and Biotherapeutics track, and Dr Harvey Klein as Chairman, Dr Paul Strengers as Vice-chairman and Dr Anthony Hubbard and Dr Micha Nübling as Rapporteurs for the Blood Products and Related Substances track. The Committee adopted the agenda (WHO/ BS/ ) and the timetable proposed. WHO Technical Report Series, No. 978,

17 2. General 2.1 Current directions Strategic directions in biological standardization The Committee was informed of WHO priorities in biological standardization, and the importance of the lessons learnt from the H1N influenza pandemic with respect to production and use of, and access to, vaccines for global public health emergencies. The Committee discussed the need to ensure the availability of influenza reagents and high-yielding seed lots in a timely manner and the use of new production systems and adjuvants for influenza vaccines. New developments in global immunization were described, including the Decade of the Vaccine, which was a major new initiative for research, development and delivery of vaccines for the world s poorest children. The Committee expressed its support for the new initiative and the opportunities it presented. The Committee supported the role of WHO in the development of standards to facilitate this initiative. It emphasized the importance of regulatory strengthening, especially in the countries where the production of vaccines was a new activity, so that only vaccines of assured quality were used in national immunization programmes. The Committee was also informed of the World Health Assembly (WHA) resolution of 2010 (WHA 63.12) on the availability, safety and quality of blood products (2), which was based on related discussions at its previous meetings. Other topics presented to the Committee included a WHO initiative on genomics and public health; an international forum hosted by the American Association for Clinical Chemistry on clinical laboratory testing through harmonization; and WHO s position on animal testing for product development and control. The Committee noted and agreed with the importance of the described activities Vaccines and biological therapeutics: recent and planned activities in biological standardization A review of WHO s recent and planned activities relating to the standardization of vaccines and similar biotherapeutic products, was presented to the Committee. Included in the review was an update on current and potential future WHO collaborating centres that support the work of the Committee. WHO was encouraging its collaborating centres to be more involved in various product areas, and was making efforts to improve the administrative process for assignment and reassignment of such centres. The Committee commended these initiatives. The Committee also reviewed WHO s plans for development of written standards and updating of existing documents. New processes were described 3

18 WHO Expert Committee on Biological Standardization Sixty-first report for posting draft documents on the WHO web site for public comments and also for posting the documents recommended for adoption by the Committee, prior to their formal publication in the WHO Technical Report Series. The Committee welcomed the new processes and expressed its support for the priorities proposed for its meetings in namely dengue, bacille Calmette Guérin (BCG) and diphtheria tetanus pertussis (DTP) vaccines, combined vaccines based on DTP, oral or injected polio vaccine, and malaria vaccine. The importance of continuing to develop standards in a proactive manner at an early stage of product development was emphasized. The status of the WHO cell banks was presented and the Committee was informed that WHO Vero cell reference bank had been shown to be free of porcine circoviruses and porcine parvoviruses. The Committee expressed its support for the continuing work on similar biotherapeutics products. It pointed out that stem cells would be an area of development and growth over the next few years and recommended that WHO be involved in the area and be prepared to develop guidance as appropriate. WHO Technical Report Series, No. 978, Blood products and related in vitro diagnostics: recent and planned activities in biological standardization The Committee was presented with an overview of accomplishments and planned activities for blood products and related biologicals. Resolution WHA63.12 (2) was discussed; this addressed associated in vitro medical devices for the first time. The Committee noted that one intention of the resolution was to strengthen NRAs for regulatory oversight of blood and blood products. However, there was a need to identify financial partners and foster advocacy for this activity. The Committee supported the resolution and its implementation. The WHO strategic plan for products derived from human and animal blood was discussed. The Committee was reminded of the recently established WHO Guidelines for the production, control and regulation of snake antivenom immunoglobulins (3). To complement the guidance document, a new WHO web site on the production and availability of snake antivenoms had been established. Maintaining the web site was a priority and the Committee supported its continuation. The key deliverables for 2010 included WHO Guidelines on good manufacturing practices (GMP) for blood establishments, updating of WHO tables on tissue infectivity distribution of transmissible spongiform encephalopathies (TSEs), assessment criteria for blood regulatory systems, and a workshop on blood products at the forthcoming International Conference of Drug Regulatory Authorities. The Committee agreed with these priorities. The Committee was also informed of the Achilles project, which aimed to increase the availability of essential plasma-derived products for developing 4

19 General countries, by supporting the implementation of national validated quality and safety standards for plasma for fractionation. Plans for the standardization of in vitro biological diagnostic technologies for the detection of microbial agents with an impact on the regulation and control of the safety of blood and blood products were also described. The Committee supported these activities. 2.2 Reports WHO Blood Regulators Network Dr Jay Epstein provided a report from the Blood Regulators Network (BRN), which had been established in response to the recommendations of the Committee in The membership is composed of representatives from NRAs that have a comprehensive responsibility for blood regulation, and the necessary expertise and capacity to address emerging public health challenges. He reviewed recent activities of the group, including examining the implications of identification of murine-leukaemia-virus-related human retroviruses; reviewing the draft document describing the development of assessment criteria for national blood regulatory systems; and technical support and advocacy for the resolution WHA63.12 (2). The group had exchanged information on a variety of issues, for example, maintaining the blood supply in the face of an influenza pandemic; a Q-fever outbreak in the Netherlands; and thrombotic adverse events associated with the use of Octagam (intravenous immunoglobulin 5%). The Committee was informed that the agenda for the next BRN meeting included the process for establishing new memberships, completion of the assessment criteria for the national blood regulatory systems, review of the WHO storage and transport of time- and temperature-sensitive pharmaceutical preparations for relevance to blood components, and topical updates. The Committee noted the report. It recommended that the terms of reference of the BRN be revised to clarify the process for admittance of new members Reports from the WHO international laboratories and collaborating centres for biological standards The Committee was informed of recent developments at the WHO international laboratories and collaborating centres for biological standards. National Institute for Biological Standards and Control (NIBSC), Potters Bar, England The Committee was informed that NIBSC had a new influenza resource centre and that the stem cell bank in the United Kingdom had opened. A reorganization of the Health Protection Agency, which included NIBSC, was under way. This may have an impact on NIBSC s role and responsibilities. 5

20 WHO Expert Committee on Biological Standardization Sixty-first report NIBSC had developed 14 of the proposed reference preparations for consideration by the Committee for adoption and establishment at the current meeting. In 2009, there had been a 31% increase in the number of WHO International Standards ordered by national control laboratories. Some of the scientific highlights since the sixtieth meeting had included investigating the finding of porcine circoviruses in rotavirus vaccines; investigation of adverse events associated with intravenous immunoglobulin (IVIG); responding to H1N pandemic influenza; and ongoing investigations of the contaminated heparin event. NIBSC had developed improved tests that had enabled anti-a and anti-b limits to be introduced for IVIG in one area of the world and thus reduce adverse events; had improved diphtheria potency testing; and had developed a rapid polymerase chain reaction (PCR)-based assay for cytokines. NIBSC was also opening up new areas, such as standards for genetic testing, standards for biosimilars and standards for the development of nucleic-acid-based diagnosis of infectious disease. Commenting on the opening of the stem cell bank in the United Kingdom, the Committee noted that it was essential that development of cellbased medicines be underpinned by a sound regulatory science platform. It was noted that activities were under way in multiple countries, including Canada, the USA and countries in the European Union, to develop scientific principles and guidance in these areas. The Committee was supportive of this initiative and recommended sharing of information on the outcomes of these activities and on the safety of clinical trials using these products. WHO Technical Report Series, No. 978, 2013 WHO Collaborating Centre for Quality Assurance of Blood Products and in vitro Diagnostic Devices, Paul-Ehrlich-Institute (PEI), Langen, Germany PEI was redesignated in July 2009 as a WHO Collaborating Centre for Quality Assurance of Blood Products. The Institute was planning to expand the scope of its collaboration to include vaccines, gene therapy, and cell and tissue therapy. An overview of PEI s organization and scope of responsibilities and of the collaborative workplan with WHO was presented. The workplan included initiatives such as the development of a panel of parvovirus B19 genotypes for nucleic acid amplification test (NAT)-based assays, development of an International Standard for hepatitis E virus RNA for NAT, and an International Standard for hepatitis C core antigen. PEI would also explore a new factor VIII potency assay. The Committee was informed that PEI had also developed training courses for regulatory authority personnel. PEI was working with other WHO collaborating centres on a variety of issues, including the BRN. The Committee expressed its support for the collaborative efforts of PEI and commended the Institute s efforts to provide training for NRA personnel from other countries. 6

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