4 Cell lines for vaccine
production
Isabelle Knott
GSK, Rixensart, Belgium
Jean-Philippe Matheise, Isabelle Ernest, and
Jean-Pol Cassart
GSK, Wavre, Belgium
CONTENTS
4.1 Introduction.....................................................................................................58
4.2 Basic and Technical Considerations..............................................................58
4.2.1 Basic Considerations (Including Vaccine Types and Cell Lines)....58
4.2.2 Technical Considerations ...................................................................61
4.2.2.1 Cell Banks............................................................................62
4.2.2.2 Viral Seeds...........................................................................62
4.2.2.3 Technology Evolution .........................................................63
4.3 Viral Safety.....................................................................................................63
4.3.1 Risk and Impacts................................................................................63
4.3.2 Sources of Viral Contaminations.......................................................64
4.3.3 Levels of Risk ....................................................................................65
4.3.4 Case Study: The PCV1/Rotarix Incident...........................................66
4.3.5 Viral-Risk Assessment .......................................................................67
4.3.6 Regulatory Considerations .................................................................68
4.3.7 Raw Materials: From Biological Materials to Chemically Defined
Materials for Cell Lines.....................................................................70
4.4 Analytical Considerations and Cell-Based Assays .......................................70
4.4.1 Safety Tests and Future .....................................................................70
4.4.1.1 In Vitro and in Vivo Safety Tests ......................................70
4.4.1.2 New Technologies...............................................................71
4.4.2 Cell Line−Based Assays and the Future ...........................................72
4.4.2.1 Potency Tests.......................................................................72
4.4.3 Molecular Assays and Control of the Viral Risk in the Future.......74
4.5 Conclusions.....................................................................................................75
Acknowledgments....................................................................................................75
References................................................................................................................75
DOI: 10.1201/9781003229797-4
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