This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Abstract - #307141
Title: WITHDRAWN: Statistics in Bioprocess Development
Author(s): Priya Kulkarni and Dan Coleman
Keywords: Design of Experiments ; Bioprocess ; characterization ; Plackett-Burman ; Regression ; Critical Process Parameters

Protein therapeutics are produced in the bacterial or mammalian cell culture by genetically modifying the host cell DNA. Unlike conventional small molecule drugs, protein therapeutics typically are diverse mixtures of product variants that differ slightly from one another making them difficult to characterize. A consistent product quality is ensured by identifying and controlling attributes of the product that affect patients, called critical quality attributes (CQA's). The validation requires identification of the critical process parameters (CPP's), parameters that have significant impact on CQA's. At Genentech, statistical Design of Experiments is an essential tool for identifying the CPP's and determining their operating ranges. In this poster, we discuss how characterization studies for the Cell Culture stage were planned and analyzed.

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