BIOT 164 |
| A pharmaceutical product has many quality attributes. Each attribute of each dose of the product must meet the specification. The definition of how to operate the manufacturing process in order to produce acceptable product is called the design space. International Conference on Harmonisation document Q8 provides guidance on the requirements for a design space but does not impose limits on how to determine or define the design space. A systematic method for the determination of the design space is helpful because of the complexity of manufacturing processes and the large number of specifications to be met. A table which mathematically relates each attribute to the appropriate steps in the process can be used to define the design space in order to achieve a desired process capability index (Cpk) for that attribute. The table can also be used to organize the laboratory experimentation for the definition of design space. This talk will describe how to connect the design space to Cpk with this systematic method and includes examples from the purification of products from cell culture. |
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Commercialization of Biologics: Impact of Design Space Philosophy & Emerging Regulations on Process Validation
3:00 PM-5:20 PM, Tuesday, August 21, 2007 BCEC -- 108, Oral
Division of Biochemical Technology |