Genetic Stability and Recombinant Product Consistency

Overview

This publication assesses the current state of technology aimed at ensuring the high quality of recombinant-derived biologicals. It will also assist industry and regulatory authorities in their efforts to develop a consensus on the scientific criteria required for the evaluation of genetic stability and product consistency. The papers describe recent progress in methods of nucleic acid sequencing and analytical protein chemistry, as well as strategies for their application. Advances in our understanding of the ...
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Overview

This publication assesses the current state of technology aimed at ensuring the high quality of recombinant-derived biologicals. It will also assist industry and regulatory authorities in their efforts to develop a consensus on the scientific criteria required for the evaluation of genetic stability and product consistency. The papers describe recent progress in methods of nucleic acid sequencing and analytical protein chemistry, as well as strategies for their application. Advances in our understanding of the biology of gene expression are also reviewed. This information is related to data on the development, production and quality control of recombinant biological products. The volume also provides a useful discussion of the value of different approaches.
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Product Details

Table of Contents

Genetic Stability and Recombinant Product Consistency 3
The Origins and Consequences of Genetic Instability in Prokaryotes 7
Genetic Stability of Protein Expression Systems in Yeast 13
Translational Errors during Recombinant Protein Synthesis 21
Assessing Genetic Stability at the Nucleic Acid Level 27
Genetic and Phenotypic Markers and Their Relationship to Product Quality and Consistency 31
Consistency and Stability of Recombinant Fermentations 45
Hybridoma Stability 55
Gene Stability in Mammalian Cells and Protein Consistency 67
Polymerase Chain Reaction (PCR) and Sequencing 81
Use of Polymerase Chain Reaction (PCR) in the Development of a Recombinant Organism 87
Genetic Stability of rDNA Production Systems, a Case Report 93
The Limitations of Nucleic Acid Testing 99
Human Genetic Polymorphisms 107
A Clinical Evaluation of Genetic Stability 111
Peptide Mapping of Recombinant Proteins 121
Mass Spectrometry in the Standardisation of Recombinant Products 129
Analytical Strategies for the Determination of Protein Modifications 135
Use of Biosensors to Characterize Recombinant Proteins 143
Recombinant Receptors as Probes for the Study of Genetic Stability 153
The Role of Bioassays in the Assessment of Recombinant Proteins 159
New Techniques in Protein Chemistry 165
Report on the Genetic Stability Symposium. April 10-12, 1991, West Coast Chapter, Parenteral Drug Association 177
Ensuring the Consistency of rDNA-Derived Biologicals: The Contribution of Gene Sequencing 179
Genetic Stability and Product Consistency of rDNA-Derived Biologicals from Mammalian Cells 183
Meeting Summary 187
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