Genetic Stability and Recombinant Product Consistency (DEVELOPMENTS IN BIOLOGICALS)

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.