Glyn N. Stacey & John Davis 
Medicines from Animal Cell Culture 

Medicines from Animal Cell Culture focuses on the use
of animal cell culture, which has been used to produce human and
veterinary vaccines, interferon, monoclonal antibodies and
genetically engineered products such as t PA and erythropoietin. It
also addresses the recent dramatic expansion in cell-based
therapies, including the use of live cells for tissue regeneration
and the culture of stem cells.

Medicines from Animal Cell Culture:

* Provides comprehensive descriptions of methods for cell culture
and nutrition as well as the technologies for the preservation and
characterisation of both the cells and the derived products

* Describes the preparation of stem cells and others for use in
cell-based therapies – an area of burgeoning research

* Includes experimental examples to indicate expected
results

* Covers regulatory issues from the UK, the EU and the USA and
reviews how these are developing around the world

* Addresses the key issues of standardisation and validation with
chapters on GLP and GMP for cell culture processes

Delivering insight into the exciting world of biological
medicines and directions for further investigation into specific
topics, Medicines from Animal Cell Culture is an
essential resource for researchers and technicians at all levels
using cell culture within the pharmaceutical, biotechnology and
biomedical industries. It is of value to laboratory managers in
these industries and to all those interested in this topic
alike.

Table of Content

Contributors.

Preface.

List of Abbreviations.

1 The Development of Animal Cell Products: History and Overview
(B Griffiths).

FUNDAMENTAL ELEMENTS OF CELL GROWTH MEDIA.

2 Water Purity and Regulations (P Whitehead).

3 Development and Optimization of Serum-free and Protein-free
Media (D Jayme).

4 Understanding Animal Sera: Considerations for Use in the
Production of Biological Therapeutics (R Festen).

CELL ENGINEERING FOR RECOMBINANT PRODUCTS.

5 Expression of Recombinant Biomedical Products from Continuous
Mammalian Cell Lines (SA Jeffs).

6 Production of Recombinant Viral Vaccine Antigens (SA
Jeffs).

7 A Brief Overview of the Baculovirus Expression System in
Insect and Mammalian Cells (C Mannix).

8 Stability: Establishing Clones, Genetic Monitoring and
Biological Performance (L Barnes).

9 Gene Transfer Vectors for Clinical Applications (A
Meager).

TECHNOLOGY AND FACILITIES FOR CELL CULTURE SCALE-UP.

10 Systems for Cell Culture Scale-up (J Davis).

11 Process Development and Design (DK Robinson and L Chu).

12 Facility Design for Cell Culture Biopharmaceuticals (S
Vranch).

13 Monitoring, Control and Automation in Upstream Processing (TS
Stoll and P Grabarek).

14 Services and Associated Equipment for Upstream Processing (TS
Stoll).

15 System and Process Validation (N Chesterton).

PROCESSING AND PRESERVATION OF CELLS AND PRODUCTS.

16 Cell Harvesting (P Hill and J Bender).

17 Protein Concentration (J Bender).

18 Purification Methods (M Wilson).

19 Virus Safety of Cell-derived Biological Products (PL
Roberts).

20 Formulation and Freeze Drying for Lyophilized Biological
Medicines (P Matejtschuk and P Phillips).

21 Cell Preservation (R Fleck and B Fuller).

PROPERTIES OF CELL PRODUCTS.

22 Product Characterization from Gene to Therapeutic Product (K
Baker, S Flatman and J Birch).

23 Protein Analysis (K Baker and S Flatman).

24 Glycosylation of Medicinal Products (E Tarelli).

25 Immunogenicity of Impurities in Cell-Derived Vaccines (M
Duchene, J Descamps and I Pierard).

26 Potency and Safety Assessment of Vaccines and Antitoxins: Use
of Cell-based Assays (D Sesardic).

27 Product Stability and Accelerated Degradation Studies (P
Matejtschuk and P Phillips).

CELLS AS PRODUCTS.

28 Cell Culture in Tissue Engineering (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 (F Martín, J
Jones, P Vaca, G Berná and B Soria).

30 Cells as Vaccines (AG Dalgleish and MA Whelan).

RISK ASSESSMENT AND REGULATORY ASPECTS.

31 Risk Assessment of Cell Culture Procedures (G Stacey).

32 Standardization of Cell Culture Procedures (G Stacey).

33 Good Laboratory Practice for Cell Culture Processing (B
Orton).

34 Good Manufacturing Practice for Cell Culture Processing (A
Green and G Sharpe).

35 International Regulatory Framework (R Guenther).

36 New Areas: Cell Therapy and Tissue Engineering Products
– Technical, Legal and Regulatory Considerations (L
Tsang).

Index.

About the author

Glyn Stacey works at the UK National Institute for
Biological Standards and Control and is the Director of the
National Stem Cell Bank.

John Davis edited a successul book on basic cell
culture.