Regulatory Aspects of Cells Utilized in Biotechnological Processes

There is a range of regulatory guidelines relevant to the utilization of cell lines or their products in the manufacture of both biotherapeutic and diagnostics. 

Quality assurance by means of strict quality control of all aspects of a cell culture process has always been of prime importance, given the sensitivity of cells to sub-optimal medium and environmental factors and the ease with which cells can become contaminated with viruses and other microorganisms. The potential for biological changes in scale-up of cell culture processes demands even greater standardization and testing of the system. 

This situation has now altered with increasing acceptance of alternative cell substrates, including both genetically manipulated and spontaneously transformed (but stable) cell lines for production processes. A good example is the WHO Vero 

Cell and Tissue Culture Laboratory Procedures in Biotechnology, edited by A. Doyle and J.B. Griffiths. 1998 John Wiley Sons Ltd. 

Lymphocytic choriomeningitis virus Reovirus type 3 Sendai virus Ectromelia virus K virus 

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REGULATORY ASPECTS OF CELLS UTILIZED IN BIOTECHNOLOGICAL PROCESSES... 

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