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City Framingham / / Company Antithrombin Deficiency / Deficient Patients / Antithrombin GTC Biotherapeulics Inc. / GTC Biotherapeutics Inc. / Injection GTe Biotherapeutics Inc. / EXECUTIVE SUMMARY Background GTC Biotherapeutics Inc. / Least 2 ATryn Treated / GTe / Injection GTC Biolherapeutics Inc. / ACT AE / Injection GTC Biothernpeutics Inc. / Injection GTC Biotherapeutics Inc. / Tnc / / Country New Zealand / United States / / Event FDA Phase / Product Issues / M&A / / Facility Laboratory Animal Care International / Plant Health Inspection Service / / IndustryTerm alfa manufacturing process / treatment of a rare plasma prolein disorder / manufacturing process / final product / column cleaning solutions / / MedicalCondition Validated Removal ofPrions/Scrapie / rare plasma prolein disorder / Acquired Antithrombin Deficiency / thrombophilia / headache / Treated Hereditary antithrombin deficiency / deoxyribonucleic acid deep vein thrombosis / prion disease / venous thromboembolisms / Hereditary Deficiency / AT deficiency / Disorder / thromboses / pulmonary embolism / proteins Chinese hamster ovary cells confidence interval Creutzfeldt Jakob Disease / diarrhea / prion/scrapie / Hereditary AT deficiency / hereditary antithrombin / Deep venous thrombosis / hereditary antithrombin deficiency / autosomal dominant disorder / erythema / Hereditary AT / scrapie / chronic anticoagulation / pulmonary emboli / venous thromboembolism / dizziness / thrombosis / / MedicalTreatment Vaccination / surgery / joint replacement surgery / bypass / hip replacement / / Organization Animal and Plant Health Inspection Service / USDA / Document Blood Products Advisory Committee / U.S. Food and Drug Administration / European Commission / CPB CT CVM DNA DVT EDTA ELISA EMEA FDA FFP FPFV Association for Assessment and Accreditation of Laboratory Animal Care International / Center for Veterinary Medicine / office of Orphan Products Development / Center for Biologics Evaluation and Research / / Person ELISA EMEA FDA FFP / CHO CI / / Position EXECUTIVE / / Product Vitamin K / ATryn / patients / Pregnant Females / / ProvinceOrState Massachusetts / / Technology tomography / antibodies / Pharmacokinetics / prions / recombinant DNA technology / / SocialTag 
Briefing Document - Blood Products Advisory Committee