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Adventures in Solid Phase Optimization – How I Learned to Stop Worrying and Love DOE

 Adventures in Solid Phase Optimization – How I Learned to Stop Worrying and Love DOE

 

Steve Figard, Ph.D., Abbott Laboratories

Experimental design as used for immunoassay development in the in vitro diagnostics industry requires a thorough understanding of all aspects of a given product’s composition and manufacturing. For immunoassays, a multiplicity of interactions between reagent components, sample composition, and process parameters make characterization of the process so complex and time consuming that the advantages of experimental design, or DOE, become immediately apparent. It is the strength of DOE to use statistics to define and/or optimize processes with fewer resources than standard experimental approaches. Here we present a specific case that illustrates the use of DOE in a manufacturing problem that includes optimization of that process. The coating of a microparticle solid phase with antibodies for a specific analyte failed to yield the performance necessary as assessed by three different metrics (responses). Simultaneous optimization with only two DOE experiments corrected the problems, characterized and optimized the manufacturing process, and allowed the product to go to market.

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