MARC details
| 000 -LEADER |
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| fixed length control field |
03576nam a22003975i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
978-0-387-89584-0 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20251006084430.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
100715s2009 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9780387895840 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
99780387895840 |
| 024 7# - OTHER STANDARD IDENTIFIER |
|---|
| Standard number or code |
10.1007/b102110 |
| Source of number or code |
doi |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
571.6 |
| Edition information |
23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Gee, Adrian. |
| Relator term |
editor. |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Cell Therapy |
| Medium |
[electronic resource] : |
| Remainder of title |
cGMP Facilities and Manufacturing / |
| Statement of responsibility, etc. |
edited by Adrian Gee. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
Boston, MA : |
| Name of producer, publisher, distributor, manufacturer |
Springer US, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2009. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Other physical details |
online resource. |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS |
|---|
| File type |
text file |
| Encoding format |
PDF |
| Source |
rda |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
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. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
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). |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
LIFE SCIENCES. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
CYTOLOGY. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
LIFE SCIENCES. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
CELL BIOLOGY. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Printed edition: |
| International Standard Book Number |
9780387895833 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
<a href="http://dx.doi.org/10.1007/b102110">http://dx.doi.org/10.1007/b102110</a> |
| Public note |
Ver el texto completo en las instalaciones del CICY |
| 912 ## - |
|---|
| -- |
ZDB-2-SBL |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Koha item type |
Libros electrónicos |
