Drug development assays

Glaser V. (2008) An interview with David Newman. Assay Drug Develop Technol 6 1-7. 

Xu J, Guia A, Rothwarf D, Huang M, Sithiphong K, Ouang J, et al. A benchmark study with sea/chip planar patch-clamp technology. Assay Drug Develop Technol 2003 1 1-10. 

The development of protein chip assays to determine protein function using purified components is a rapidly advancing area. Automated systems for the assay of protein function on chips in parallel for thousands of proteins simultaneously will likely be available in the next few years. These miniaturized arrays will be useful for basic research as well as for diagnostics and drug development. For instance, the combination of protein chips with combinatorial chemistry will allow the simultaneous screening of vast collections of small molecules against vast collections of potential target proteins. 

Yeh, J., and Fernandez, D. 2004. Patent protection strategies for biotechnological inventions. Assay and Drug Development Technologies 2(6), 697-702. 

Both plate reader and mass spectrometry based methods are commonly used for screening. The selection of a technique depends on instrument availability, throughput needs and the stage of compound advancement. For the characterization of compounds in drug development and clinical candidates, assays carried out using drug-like probes and analyzed by LC-MS/MS methods are considered the gold standard [117]. 

As previously reported, drug development is a time-consuming and costly process for these reasons, the need of very sensitive and selective assays for the complete characterization of New Chemical Entities (NCE) has become very stringent. 

Analytical methods are important not only in the development and manufacture of commercial biopharmaceutical drugs, they also play a vital role in the whole drug development life cycle. Drug discovery and preclinical research require development and application of analytical methodologies to support identification, quantitation, and characterization of lead molecules. It is difficult to perform a comparative potency assay on lead molecules if one does not know how much of each is going into the assay or how pure the molecule is. Analytical methods are typically developed, qualified, and validated in step with the clinical... 

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