Cell Therapy

cGMP Facilities and Manufacturing

Inbunden, Engelska, 2009

2 769 kr

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Cell Therapy offers a discussion of facility design operation issues, complete with practical approaches. This facility-focused resource also includes in-depth reviews of quality, supply management, regulation frameworks and professional standards

Produktinformation

Utgivningsdatum2009-09-25
Mått155 x 235 x 24 mm
Vikt598 g
FormatInbunden
SpråkEngelska
Antal sidor256
Upplaga2009
FörlagSpringer-Verlag New York Inc.
ISBN9780387895833

Tillhör följande kategorier

Medicinsk genetik inom Medicin
Genterapi inom Medicin
Cellbiologi inom Naturvetenskap och teknik

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.