Article

Drivers, Risks, and Enablers in Next-Generation Biomanufacturing Environments

Source: ISPE
Outsourcing Biomanufacturing Continues To Grow In Frequency

“Next-generation” biomanufacturing—what is it specifically and how does it differ from past and current installations?

David M. Marks, President and Principal Consultant, DME Engineering, explains it this way: “Next-generation biologics facilities are an alternate approach to biomanufacturing, but they are not appropriate for every production scenario. Most large-volume biotherapeutics will continue to be manufactured in traditional stainless steel facilities.” [1]

Marks says that most next-generation facilities contain some, but not all, of the following elements:

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