Essentials of Tissue Banking

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This book provides a coherent and up-to-date review of the scientific and technical principles in routine tissue banking practices, incorporating a plethora of new guidance and regulatory documents produced in response to recent regulation.

Tissue banking is undergoing a paradigm shift. There are now a plethora of guidance and regulatory documents, in response to recent regulation. There is however, relatively little information on the scientific and technical principles on routine tissue banking practices. The information that exists is relatively old and in somewhat obscure journals. This book attempts to provide a coherent and up to date approach. Each author, who is a recognized expert in their field, was asked to illustrate the processes involved in modern tissue banking practices. Where these are based on evidence and science, they were asked to explain this in a clear and concise manner. Where evidence it is not available, the authors were asked to provide the reasons why they believe practices have developed the way they have. This could range from the precautionary principle, custom and practice, common sense approach etc. This book has been split into 5 sections: Management of donors and the banking of common tissues and cells, principles of storage and processing of tissues, ensuring safety of the products by testing the donor, the tissue and the environment, ensuring quality of the products by establishing a quality system and an IT infrastructure and the Regulatory and ethical environment in which we operate. Although it is possible to bank all types of cells, including stem cells, these are not covered in this book. The organisation and target audiences for stem cells are quite different from those of tissues. Cord blood banking, on the other hand is very similar and they have therefore been included. The intention of this book is to cover the basis of current practices, rather than future developments, such as embryonic cell developments, tissue engineering and gene therapy. These are more akin to cellular therapies. Although they share many banking similarities to tissues, their inclusion in this book would have made it too cumbersome.

Aparadigmshiftistakinginraisingstandardsonallaspectsoftissuebankingfrom procurementtoprocessing,fromstoragetoclinicalusage. Anumberofmonographs haveappearedgivingguidanceonGMPandqualitysystemsthatshouldbeadhered to. Therearealsogoodguidelinesonthesigni?canceofthenewregulationsthat havebeenenacted. However there is a signi?cant lack of information on the scienti?c basis and rationaleonwhytissuebankingpracticeshavedevelopedthewaytheyhave. Many ofthemhavedevelopedwithoutmuchvalidationandhavebeeninuseformany years, copied from one tissue bank to another. There are some good articles on somescienti?caspectsoftissuebankingpractices,buttheyareinrelativelyoldand insomewhatobscurejournals. Thisbookisintendedto?llthisgapbygettinga seriesofeminentexpertstoeachwriteachapterortwoonuptodatetissuebanking practices. Moreoverinthemodernworldoftissuebanking,safetyandqualityoftissues havetakenanincreasinglyimportantrole. Infacttheseactivitiesformthebasisof manylicensureactivitiesthatrelatetotissueestablishments. Anattempthasbeen madetocovertheseaspectsaswell. Althoughthelegislationcoversalltypesofcells,includingstemcells,theyhave beendeliberatelyomitted. Thetargetaudiencesforstemcellsaredifferentandthe setupisalsogenerallyquitedifferentunlikecordblood,whichisverysimilarto tissuesandthereforeincluded. Inordertolimitthesizeofthebooktoamanageableleveltheauthorshavebeen onlyaskedtocoverthebasisofcurrentpractices,ratherthanfuturedevelopments, suchasembryoniccelldevelopments,tissueengineeringandgenetherapy,which aremorecellulartherapiesthantissuebanking,perse. Coursesconferringcert- catesanddiplomashavejuststartedtobeprovidedbyvariousprofessionalbodies. Thisisimportantbecausetissuebankingisbecomingadistinctmodalityforsci- tistswhowanttoworkinthe?eld. Ibelievesuchanaudiencewouldbeverykeen tousethisbook. Alsoanyscientistandmedicalpersonworkinginthe?eldshould beinterestedinit. Itwillalsobeusefulformanysurgeonswhousetissuesintheir dailyclinicalpractice. Iamverygratefultoalltheauthors,whowithoutexceptionwillinglygaveso muchtime,effortandenergyinwritingtheirchapters. Theyarewithoutexception, v vi Preface leadersintheir?eld. Theyhaveallproduceduptodateandstateoftheartchapters. Theyhavedoneitinthestyletheyfeltwasappropriateandnoattemptwasmadeto modifythis. Thekeyobjectivewastocollateallthisinformationinoneplace. Ihave learntalotwhilsteditingthisworkandIhopethatthereaderswillbeengrossedin readingthisbookasmuchasIhave. Edinburgh,Scotland GeorgeGalea Contents Part I Management of 1 Live Donors of Tissue ...3 RuthWarwick 2 Deceased Donors of Tissue...23 AuroraNavarro 3 Banking of Cord Blood...41 ElianeGluckman 4 Banking of Corneas...59 W. JohnArmitage 5 Banking of Heart Valves...69 RobertParker 6 Banking of Skin...81 EllenHeck Part II Principles of 7 Storage, Processing and Preservation...95 JohnN. Kearney 8 Cryopreservation...109 DavidPegg 9 Sterilisation by Irradiation ...123 ArturKaminski,IzabelaUhrynowska-Tyszkiewicz, andWaclawStachowicz Part III Ensuring Safety by 10 Testing the Donor...141 AlanKitchenandJohnBarbara 11 Testing the Tissue and the Environment ...167 TedEastlundandMartellK. Winters vii viii Contents Part IV Ensuring Quality by 12 Establishing a Quality System...191 ScottA. Brubaker 13 IT System...217 LindaLodge Part V Legal and Ethical Environment 14 Regulatory and Ethical Issues...231 DavidPegg Index ...243 Contributors W. John Armitage CTSBristolEyeBank,UniversityofBristol,BristolEye Hospital,BristolBS12LX,UK,w. j. armitage@bristol. ac. uk John Barbara NHSBloodandTransplant,ColindaleAvenue,London NW95BG,UK,Marina. mobed@nhsbt. nhs. uk Scott A. Brubaker AmericanAssociationofTissueBanks,McLean,VA22101, USA,brubakers@aatb. org Ted Eastlund DepartmentofPathology,UniversityofNewMexicoSchool ofMedicine,Albuquerque,NM87131,USA,deastlund@salud. unm. edu Eliane Gluckman Eurocord,HematologyDepartment,APHPUniversityParis VII,Paris,France,eliane. gluckman@sls. aphp.