The Resource Cell Therapy : cGMP Facilities and Manufacturing, edited by Adrian Gee, (electronic resource)

Cell Therapy : cGMP Facilities and Manufacturing, edited by Adrian Gee, (electronic resource)

Label
Cell Therapy : cGMP Facilities and Manufacturing
Title
Cell Therapy
Title remainder
cGMP Facilities and Manufacturing
Statement of responsibility
edited by Adrian Gee
Contributor
Editor
Editor
Subject
Language
  • eng
  • eng
Summary
Cell 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)
Dewey number
571.6
http://bibfra.me/vocab/relation/httpidlocgovvocabularyrelatorsedt
H-3TLFRdtfw
Image bit depth
0
Language note
English
LC call number
QH573-671
Literary form
non fiction
Nature of contents
dictionaries
http://library.link/vocab/relatedWorkOrContributorName
Gee, Adrian.
http://library.link/vocab/subjectName
  • Cytology
  • Cell Biology
Label
Cell Therapy : cGMP Facilities and Manufacturing, edited by Adrian Gee, (electronic resource)
Instantiates
Publication
Note
Bibliographic Level Mode of Issuance: Monograph
Antecedent source
mixed
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Color
not applicable
Content category
text
Content type code
txt
Contents
I. 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
Dimensions
unknown
Edition
1st ed. 2009.
Extent
1 online resource (XX, 256 p.)
File format
multiple file formats
Form of item
online
Isbn
9781461497936
Level of compression
uncompressed
Media category
computer
Media type code
c
Other control number
10.1007/b102110
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
  • (CKB)2670000000367896
  • (SSID)ssj0000316587
  • (PQKBManifestationID)11237028
  • (PQKBTitleCode)TC0000316587
  • (PQKBWorkID)10276208
  • (PQKB)10989939
  • (DE-He213)978-0-387-89584-0
  • (MiAaPQ)EBC510725
  • (EXLCZ)992670000000367896
Label
Cell Therapy : cGMP Facilities and Manufacturing, edited by Adrian Gee, (electronic resource)
Publication
Note
Bibliographic Level Mode of Issuance: Monograph
Antecedent source
mixed
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Color
not applicable
Content category
text
Content type code
txt
Contents
I. 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
Dimensions
unknown
Edition
1st ed. 2009.
Extent
1 online resource (XX, 256 p.)
File format
multiple file formats
Form of item
online
Isbn
9781461497936
Level of compression
uncompressed
Media category
computer
Media type code
c
Other control number
10.1007/b102110
Quality assurance targets
absent
Reformatting quality
access
Specific material designation
remote
System control number
  • (CKB)2670000000367896
  • (SSID)ssj0000316587
  • (PQKBManifestationID)11237028
  • (PQKBTitleCode)TC0000316587
  • (PQKBWorkID)10276208
  • (PQKB)10989939
  • (DE-He213)978-0-387-89584-0
  • (MiAaPQ)EBC510725
  • (EXLCZ)992670000000367896

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