|
|
|
|
| LEADER |
02046nam a22002655i 4500 |
| 001 |
000278870 |
| 005 |
20220125075616.0 |
| 007 |
cr nn 008mamaa |
| 008 |
100715s2009 xxu| s |||| 0|eng d |
| 020 |
|
|
|a 9780387895840
|
| 024 |
7 |
|
|a 10.1007/b102110
|2 doi
|
| 040 |
|
|
|a Sistema de Bibliotecas del Tecnológico de Costa Rica
|
| 245 |
1 |
0 |
|a Cell Therapy :
|b cGMP Facilities and Manufacturing /
|c edited by Adrian Gee.
|
| 250 |
|
|
|a 1st ed. 2009.
|
| 260 |
# |
# |
|a New York, NY :
|b Springer US :
|b Imprint: Springer,
|c 2009.
|
| 300 |
|
|
|a XX, 256 p. :
|b online resource.
|
| 336 |
|
|
|a text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a computer
|b c
|2 rdamedia
|
| 338 |
|
|
|a online resource
|b cr
|2 rdacarrier
|
| 505 |
0 |
|
|a 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.
|
| 650 |
|
0 |
|a Cell biology.
|
| 650 |
1 |
4 |
|a Cell Biology.
|
| 700 |
1 |
|
|a Gee, Adrian.
|e editor.
|
| 710 |
2 |
|
|a SpringerLink (Online service)
|
| 773 |
0 |
|
|t Springer eBooks
|