MedicinesfromAnimalCellCulture.pdf

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Contents
Contributors ix
Preface xiii
List of Abbreviations xv
1 The Development of Animal Cell Products: History and Overview 1
B Griffi ths
FUNDAMENTAL ELEMENTS OF CELL GROWTH MEDIA 15
2 Water Purity and Regulations 17
P Whitehead
3 Development and Optimization of Serum-free and Protein-free Media 29
D Jayme
4 Understanding Animal Sera: Considerations for Use in the Production
of Biological Therapeutics 45
R Festen
CELL ENGINEERING FOR RECOMBINANT PRODUCTS 59
5 Expression of Recombinant Biomedical Products from Continuous
Mammalian Cell Lines 61
SA Jeffs
6 Production of Recombinant Viral Vaccine Antigens 79
SA Jeffs
7 A Brief Overview of the Baculovirus Expression System in Insect
and Mammalian Cells 101
C Mannix
8 Stability: Establishing Clones, Genetic Monitoring and Biological
Performance 113
L Barnes
9 Gene Transfer Vectors for Clinical Applications 125
A Meager
vi CONTENTS
TECHNOLOGY AND FACILITIES FOR CELL CULTURE SCALE-UP 143
10 Systems for Cell Culture Scale-up 145
J Davis
11 Process Development and Design 173
DK Robinson and L Chu
12 Facility Design for Cell Culture Biopharmaceuticals 187
S Vranch
13 Monitoring, Control and Automation in Upstream Processing 203
TS Stoll and P Grabarek
14 Services and Associated Equipment for Upstream Processing 245
TS Stoll
15 System and Process Validation 285
N Chesterton
PROCESSING AND PRESERVATION OF CELLS AND PRODUCTS 303
16 Cell Harvesting 305
P Hill and J Bender
17 Protein Concentration 331
J Bender
18 Purifi cation Methods 347
M Wilson
19 Virus Safety of Cell-derived Biological Products 371
PL Roberts
20 Formulation and Freeze Drying for Lyophilized Biological
Medicines 393
P Matejtschuk and P Phillips
21 Cell Preservation 417
R Fleck and B Fuller
PROPERTIES OF CELL PRODUCTS 433
22 Product Characterization from Gene to Therapeutic Product 435
K Baker, S Flatman and J Birch
23 Protein Analysis 443
K Baker and S Flatman
CONTENTS vii
24 Glycosylation of Medicinal Products 479
E Tarelli
25 Immunogenicity of Impurities in Cell-Derived Vaccines 491
M Duchene, J Descamps and I Pierard
26 Potency and Safety Assessment of Vaccines and Antitoxins:
Use of Cell-based Assays 497
D Sesardic
27 Product Stability and Accelerated Degradation Studies 503
P Matejtschuk and P Phillips
CELLS AS PRODUCTS 523
28 Cell Culture in Tissue Engineering 525
TE Hardingham, CM Kielty, AE Canfi eld, SR Tew, SG Ball, NJ Turner
and KE Ratcliffe
29 The Use of Stem Cells in Cell Therapy 543
F Martín, J Jones, P Vaca, G Berná and B Soria
30 Cells as Vaccines 559
AG Dalgleish and MA Whelan
RISK ASSESSMENT AND REGULATORY ASPECTS 567
31 Risk Assessment of Cell Culture Procedures 569
G Stacey
32 Standardization of Cell Culture Procedures 589
G Stacey
33 Good Laboratory Practice for Cell Culture Processing 603
B Orton
34 Good Manufacturing Practice for Cell Culture Processing 613
A Green, G Sharpe
35 International Regulatory Framework 621
R Guenther
36 New Areas: Cell Therapy and Tissue Engineering Products

航行

这英语不好我还看不懂呢  不过谢谢楼主提供材料  我找朋友帮看看啥意识

海子

动物细胞培养物药物，不过就是英文不好，看不懂，呵呵

胜利者

楼主太伟大

alpha

看起来不错，动物细胞的书还是蛮新的