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Technology-Specific Regulatory Considerations

Great progress was achieved in the past decades regarding the development of mammalian cell culture technology [2,34,98-102]. Nevertheless, the design and layout of cultivation systems and bioreactors have to meet cell-specific demands due to the special characteristics of these cells. Selection of a suitable type of cell culture bioreactor system and/or an appropriate operation mode (batch, fed-batch, or perfusion) is affected by technical, biological, economical, and regulatory considerations. [Pg.140]

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Regulatory considerations

Specification considerations

Specificity technologies

Technological Considerations

Technological Specifications

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