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WHO Guidelines for the Production, Control and Regulation of Snake Antivenom Immunoglobulins

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WHO Guidelines for the Production, Control and Regulation of Snake Antivenom Immunoglobulins Post ECBS version ENGLISH ONLY EXPERT COMMITTEE ON BIOLOGICAL STANDARDIZATION Geneva, 17 to 21 October 2016 WHO Guidelines for the Production, Control and Regulation of Snake Antivenom Immunoglobulins © World Health Organization 2016 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). 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. 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. The named authors [or editors as appropriate] alone are responsible for the views expressed in this publication. Adopted by the Sixty-seventh Meeting of the World Health Organization Expert Committee on Biological Standardization, 17- 21 October 2016. A definitive version of this document, which will differ from this version in editorial but not scientific details, will be published in the WHO Technical Report Series. This is a pre-publication ECBS-approved document but may yet be subject to minor editing to meet WHO style guide and other requirements. Post ECBS version Page 2 CONTENTS 1 Introduction ............................................................................................................................................6 1.1 Scope and application of the Guidelines ................................................................................................7 2 List of abbreviations and definitions ....................................................................................................8 3 The ethical use of animals ...................................................................................................................13 3.1 Ethical considerations for the use of venomous snakes in the production of snake venoms ...............13 3.2 Ethical considerations for the use of large animals in the production of hyperimmune plasma..........13 3.3 Ethical considerations for the use of animals in preclinical testing of antivenoms .............................14 3.4 Development of alternative assays to replace murine lethality testing ................................................14 3.5 Refinement of the preclinical assay protocols to reduce pain, harm and distress to experimental animals .................................................................................................................................................14 3.6 Main recommendations ........................................................................................................................15 4 General considerations ........................................................................................................................16 4.1 Historical background ..........................................................................................................................16 4.2 The use of serum versus plasma as source material.............................................................................16 4.3 Antivenom purification methods and product safety ...........................................................................16 4.4 Pharmacokinetics and pharmacodynamics of antivenoms...................................................................16 4.5 Need for national and regional reference venom preparations ............................................................17 5 Epidemiological Background ..............................................................................................................18 5.1 Global burden of snakebites ................................................................................................................18 5.2 Main recommendations ........................................................................................................................18 6 Worldwide distribution of venomous snakes.....................................................................................20 6.1 Taxonomy of venomous snakes ...........................................................................................................20 6.2 Medically important venomous snakes ................................................................................................23 6.3 Minor venomous snake species ...........................................................................................................25 6.4 Sea snake venoms ................................................................................................................................26 6.5 Main recommendations ........................................................................................................................26 7 Antivenoms design: selection of snake venoms .................................................................................29 7.1 Selection and preparation of representative venom mixtures ..............................................................29 7.2 Manufacture of monospecific or polyspecific antivenoms ..................................................................29 7.2.1 Monospecific antivenoms ..............................................................................................29 7.2.2 Polyspecific antivenoms ................................................................................................29 7.3 Main recommendations ........................................................................................................................30 8 Preparation and storage of snake venom ...........................................................................................31 8.1 Production of snake venoms for immunization ...................................................................................31 8.1.1 Quarantine of snakes .....................................................................................................31 8.1.2 Maintenance of captive snakes for venom production ..................................................32 8.1.3 General maintenance of a serpentarium .......................................................................33 8.1.4 Snake venom production ...............................................................................................34 8.2 Staff responsible for handling snakes ..................................................................................................35 8.2.1 Safety and health considerations ...................................................................................35 8.2.2 Personal Protective Equipment (PPE) for snake or venom handling ...........................36 8.2.3 Procedures to be followed if a bite occurs ....................................................................36 8.3 Main recommendations ........................................................................................................................37 9 Quality control of venoms ...................................................................................................................38 9.1 Records and traceability .......................................................................................................................38 9.2 National reference materials ................................................................................................................38 9.3 Characterization of venom batches ......................................................................................................38 9.4 Main recommendations ........................................................................................................................39 10 Overview of the production process of antivenoms ..........................................................................40 11 Selection and veterinary health care of animals used for production of antivenoms ....................42 Post ECBS version Page 3 11.1 Selection and Quarantine period .......................................................................................................... 42 11.2 Veterinary care, monitoring and vaccinations ..................................................................................... 42 11.3 Animal health and welfare after inclusion in the herd ......................................................................... 42 11.4 Main recommendations.......................................................................................................................
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