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020 _a9780387895840
_99780387895840
024 7 _a10.1007/b102110
_2doi
035 _avtls000333317
039 9 _a201509031107
_bVLOAD
_c201405070453
_dVLOAD
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040 _aMX-SnUAN
_bspa
_cMX-SnUAN
_erda
050 4 _aQH573-671
100 1 _aGee, Adrian.
_eeditor.
_9306166
245 1 0 _aCell Therapy :
_bcGMP Facilities and Manufacturing /
_cedited by Adrian Gee.
264 1 _aBoston, MA :
_bSpringer US,
_c2009.
300 _brecurso en línea.
336 _atexto
_btxt
_2rdacontent
337 _acomputadora
_bc
_2rdamedia
338 _arecurso en línea
_bcr
_2rdacarrier
347 _aarchivo de texto
_bPDF
_2rda
500 _aSpringer eBooks
505 0 _aI. Regulatory -- Regulation of Cell Product Manufacturing and Delivery: A United States Perspective -- The Regulatory Situation for Academic Cell Therapy Facilities in Europe -- A Regulatory System for Cell and Tissue Therapies: Proposed Approach in Australia -- II. GMP Facility Design -- University of Minnesota - Molecular and Cellular Therapeutics (MCT) -- University of Pittsburgh Cancer Institute - Hematopoietic Stem Cell Laboratory (HSC Lab)/Immunological Monitoring and Cellular Products Laboratory (IMCPL) -- Baylor College of Medicine - Center for Cell and Gene Therapy (CAGT) -- Design of a New GMP Facility - Lessons Learned -- III. Professional Cell Therapy Standards -- AABB Cell Therapy Standards -- Professional Standards for Cellular Therapies: Foundation for the Accreditation of Cellular Therapy (FACT) -- IV. Facility Operations -- Standard Operating Procedures -- Staffing, Training, and Competency -- Cleaning Procedures -- Environmental Monitoring -- Supply Management -- Facility Equipment -- Quality -- Product Manufacturing -- Product Review, Release, and Administration -- Use of a Facility Master File to Facilitate Regulatory Submissions for Cell Therapy Products.
520 _aCell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing… Standard operating procedures Supply management Facility equipment Product manufacturing, review, release and administration Facility master file This volume contains a collection of chapters authored by individuals who are active in the field of cell therapy product manufacturing. The collection and editing of these chapters was supported in part by the National Institutes of Health (National Heart, Lung and Blood Institute) program Production Assistance for Cellular Therapies (PACT).
590 _aPara consulta fuera de la UANL se requiere clave de acceso remoto.
710 2 _aSpringerLink (Servicio en línea)
_9299170
776 0 8 _iEdición impresa:
_z9780387895833
856 4 0 _uhttp://remoto.dgb.uanl.mx/login?url=http://dx.doi.org/10.1007/b102110
_zConectar a Springer E-Books (Para consulta externa se requiere previa autentificación en Biblioteca Digital UANL)
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999 _c280906
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