European Community and US-FDA Approval of Recombinant Human Antithrombin Produced in Genetically Altered Goats

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dc.authorwosidIqbal, Muhammad Omer/ABI-4539-2020
dc.contributor.authorAdiguzel, Cafer
dc.contributor.authorIqbal, Omer
dc.contributor.authorDemir, Muzaffer
dc.contributor.authorFareed, Jawed
dc.date.accessioned2024-06-12T11:13:25Z
dc.date.available2024-06-12T11:13:25Z
dc.date.issued2009
dc.departmentTrakya Üniversitesien_US
dc.description.abstractThrombin and factor Xa play a central role in thrombogenesis in both medical and surgical patients. Antithrombin (AT) is the key inhibitor, which controls the action of these enzymes in hypercoagulable states. The AT concentrates prepared from human blood have been used to treat patients with thrombotic disorders and heparin resistance. The AT concentrates are prepared from pooled human plasma and beside limited supply, suffer from viral and other biological contaminants. The availability of recombinant human AT (rhAT) obtained from genetically engineered goats provide a biologically equivalent product that can be used in practically all indications where human AT is indicated including heparin resistance. Moreover, because of its high affinity to heparin and related drugs, recombinant AT can also be developed in further indications. On review of the preclinical and clinical data on the safety and efficacy, the European Union and U.S. Food and Drug Administration (US-FDA) have recently approved the use of rhAT in specified clinical indications.en_US
dc.description.sponsorshipTurkish Society of Hematology; Loyola University Medical Centeren_US
dc.description.sponsorshipThe authors gratefully acknowledge the support of Turkish Society of Hematology tor promoting the scientific collaboration between Marmara University Medical School and Loyola University Medical Center. This review was developed during the visiting fellowship of the senior author (Cafer Adiguzel, MID) at the Hemostasis and Thrombosis Research Laboratories of the Loyola University Medical Center. We are also thankful to the staff of Hemostasis and Thrombosis Research Laboratories of the Loyola University Medical Center for their help and cooperation.en_US
dc.identifier.doi10.1177/1076029609339748
dc.identifier.endpage651en_US
dc.identifier.issn1076-0296
dc.identifier.issn1938-2723
dc.identifier.issue6en_US
dc.identifier.pmid19850586en_US
dc.identifier.startpage645en_US
dc.identifier.urihttps://doi.org/10.1177/1076029609339748
dc.identifier.urihttps://hdl.handle.net/20.500.14551/23550
dc.identifier.volume15en_US
dc.identifier.wosWOS:000271934800006en_US
dc.identifier.wosqualityQ3en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherSage Publications Incen_US
dc.relation.ispartofClinical And Applied Thrombosis-Hemostasisen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectRecombinant Antithrombinen_US
dc.subjectHypercoagulabilityen_US
dc.subjectThrombosisen_US
dc.subjectGenetically Altered Goatsen_US
dc.subjectAntithrombin Deficiencyen_US
dc.subjectAnti-Thrombin-Iiien_US
dc.subjectHeparin-Resistant Patientsen_US
dc.subjectMammary-Glanden_US
dc.subjectCardiopulmonary Bypassen_US
dc.subjectDeficiency Statesen_US
dc.subjectTransgenic Goatsen_US
dc.subjectMilken_US
dc.subjectExpressionen_US
dc.subjectHeterogeneityen_US
dc.subjectCoagulationen_US
dc.titleEuropean Community and US-FDA Approval of Recombinant Human Antithrombin Produced in Genetically Altered Goatsen_US
dc.typeArticleen_US

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