LC-MS Bioanalysis: The Role of Bioanalytical Solutions in Phase II of Drug Development

Drug discovery and development is a complex endeavor. It involves discovering, synthesizing, and developing potent biotherapeutics. Various divisions of the industry and academics are continuously involved in  designing and developing  novel drug compounds with improved efficacy and reduced toxicity. Bioanalysis is a promising branch of drug development science that has proved beneficial in identifying and developing products. 

Bioanalysis consists of several robust bioanalytical solutions techniques. LC-MS is one such crucial bioanalytical technique. HPLC-MS analysis, more commonly called LC-MS, combines  two robust analytical methods, liquid chromatography, and mass spectrometry. The liquid chromatography components separate molecules using a mobile and solid stationary phase. On the other hand, mass spectrometers identify individual analytes based on their mass-to-charge ratio. The combination of this robust technique makes LC-MS a crucial component of drug development and drug discovery processes. The current article explores LC-MS bioanalysis in phase II of drug development. 

LC-MS bioanalysis in drug development

LC-MS bioanalysis is essential at each stage of preclinical and clinical drug development. The primary goal of preclinical studies is to identify safe doses for first-in-human studies and determine the potential toxicity of the drug product. Here LC-MS based tools identify degradants, contaminants, and drug metabolites. The clinical drug development stage comprises three distinct phases. Phase I clinical studies experiment with a drug in a small group of healthy people to evaluate its safety and efficacy.

Phase II clinical trials test the drug in more patients with an emphasis on effectiveness. Once a drug passes phase I and phase II clinical trials, in the final phase III studies, it is  tested on a larger number of patient populations for its potential safety, drug doses, and efficacy in different patient populations. Only after a drug passes all stages of clinical trials, the FDA approves its use for the intended patient population. 

LC-MS bioanalysis has progressed and reached research facilities and laboratories doing routine analysis. Today tandem mass spectrometry has established itself in clinical research. The specificity and high throughput capacities of LC-MS/MS analysis have proven beneficial to diagnostic laboratories for conducting routine bioanalysis. Besides advances in API, MS/MS systems and LC components have resulted in the advent of numerous clinical diagnostic tests. 

During phase II clinical trials, LC-MS bioanalysis is used frequently to test steroid hormones. Differential steroid assessment is crucial for diagnosing and treating complex disorders such as adrenal insufficiency, primary hyperaldosteronism, congenital adrenal hyperplasia, gonadal dysfunction, and Cushing’s syndrome. Today assessing these multi-dysfunctions conditions is only possible due to multi-dimensional tandem spectroanalysis. Moreover,  mass spectrometers can now examine blood spots due to MALDI ionization. For example, this technique can assess for phenylketonuria during newborn screening. 

LC-MS bioanalysis is vital for identifying and measuring impurities in active pharmaceutical ingredients. This task is crucial at several stages of drug development. Only a robust impurity qualification system can ensure the biological safety of an active pharmaceutical ingredient. LC-MS bioanalysis provides a reliable tool for structural identification and analysis of impurities.

In Conclusion

LC-MS bioanalysis is not only critical for phase II drug development studies, but they have numerous applications ranging from drug discovery studies to clinical trials and post-marketing assessments. 

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