System suitability bioanalytical

The optimization and validation of immunoassays for immunogenicity (ADA) testing has been described in detail in several publications [9,14,33,34]. In this section, we will describe the evaluation of relevant performance characteristics (validation parameters) that require the most effort. Some of these are different from the validation of traditional bioanalytical pharmacokinetic (PK) methods for macromolecules [35 37]. Precision, specificity, robustness, and ruggedness are determined similarly between ADA and PK methods. However, recovery/accuracy, sensitivity, stability, linearity, system suitability controls, and selectivity are treated differently between these two types of assays. 

Another sensor based on a fiber-optic-based spectroelectrochemical probe uses a DNA/ethidium bromide system to take advantage of the biological recognition processes [92]. The concept of immobilizing electrochemical reagents on the end of an optical fibre is a useful addition to the field of bioanalytical sensors. Before this development, optical and electrochemical detection of DNA were performed separately. Optical and electrochemical detection of DNA are suitable for a DNA detection system [93, 94] and these techniques will enable a production of a cheap DNA biosensor with a rapid and quantitative response. 

Table 19-7. Selected types of compounds suitable for oxidative or reductive electrochemical detection (Courtesy - Bioanalytical Systems Inc., West Lafayette, IN)...

In addition to its suitability for synthesis of hybrid bio/organic-Tnorganic materials, sol/gel is also a processing technology that can be used for fabricating frmctional coatings, components and devices. Many ofthe new micro-analytical systems utilize microfluidic electronic and optical based bioanalytical platforms, and rely on surface fimctionahzation... 

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