High-throughput and low-cost

The decision on which type of method to use for the ADA screening/confirmation assays will depend upon the structure of the drug and conclusions from the risk assessment. The most common and first approach is to use an ELISA-based LBA method, which offers quick development times, high throughput, and low cost. However, more complex method platforms (possibly more sensitive) such as, ECL or SPR assays may need to be developed if the ELISA platform does not meet the program s needs. While not commonly used, RIPA methods can provide many of the positive attributes of the ELISA with increased sensitivity. 

These requirements seem to be hatched at the green table , because, if they were to be fulfilled completely, the practicability requirements of the Commission Decision such as high sample throughput and low cost could never be met. 

Vukjovic et al.199 recently proposed a simple, fast, sensitive, and low-cost procedure based on solid phase spectrophotometric (SPS) and multicomponent analysis by multiple linear regression (MA) to determine traces of heavy metals in pharmaceuticals. Other spectroscopic techniques employed for high-throughput pharmaceutical analysis include laser-induced breakdown spectroscopy (LIBS),200 201 fluorescence spectroscopy,202 204 diffusive reflectance spectroscopy,205 laser-based nephelometry,206 automated polarized light microscopy,207 and laser diffraction and image analysis.208... 

Methods employing low sample volumes (< pL) have been explored, which are aimed at the high-throughput and cost-effective exploration of the design space for chromatographic separations, especially related to bioanalytical techniques focused on large biomolecules analyses (proteins and peptides). 

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