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LC/MS-MS Method: Challenges Drug Developing Labs Encounter

Historically, mass spectrometers were not readily used in clinical settings. However, development in API techniques with tandem mass spectrometry helped LC-MS systems enter the clinical laboratory environment. The past decade has seen LC-MS/MS assays play vital roles in preclinical and clinical studies. However, researchers still face challenges while using LC-MS/MS assays. The current article highlights some obstacles drug developer labs encounter with LC-MS/MS systems.

 

LC-MS/MS challenges for drug development

 

Although the cost and technical complexity have substantially decreased, LC-MS assays still have challenges such as assay development and validation obstacles, standardized assays, and technical expertise. Researchers must overcome specific LC-MS/MS challenges before converting a highly specialized and technical method into a routine clinical testing technique. Let us explore each of these challenges in detail.

 

LC-MS method development and validation

 

Numerous LC-MS/MS methods used in drug development studies are developed in clinical laboratories. However, laboratories have to develop or acquire high-quality standards and quality controls. Hence, it is expected from these laboratories to adequately develop and validate each LC-MS/MS system before deploying it for routine use. 

 

Today companies are focusing on developing ready-to-use test kits for LC-MS/MS testing. An example of such FDA cleared kit is the Waters MassTrak Immunosuppressants kit which was developed to manage tacrolimus therapy in kidney and liver transplant patients. Developing such FDA-approved kits shall help researchers overcome most issues regarding method development and validation. 

 

Standardization

 

Differences between laboratory results are the primary reason for the primitive use of LC-MS/MS systems in clinical laboratories. Researchers must overcome the lack of harmonization and standardization of LC-MS/MS procedures for their routine use in clinical settings. Regulatory bodies are now making efforts to mold LC-MS systems into a standard bioanalytical technique for approaches such as estimating vitamin D and testosterone.

 

In early 2010, the CDC and the Endocrine Society released a consensus statement for accurate testing of testosterone that to  improve the diagnosis and treatment of diseases. This effort was addressed to testosterone measurement through both immunoassays and LC-MS assays. Similarly, in the UK, DEQAS, a testing scheme for vitamin D, was developed to ensure the reliability of 1,25 dihydroxy vitamin D and 25 hydroxy vitamin D assays in measuring vitamin D levels.

 

Technical expertise

 

A highly trained staff is crucial not only for conducting method development and validation but also for everyday LC-MS/MS operations. These trained teams will also include doctoral-level professionals for running and troubleshooting operations. Though laboratory technicians can effectively conduct daily LC-MS operations, highly skilled staff is essential for more complex projects. However, finding such talent is very challenging. Approaches such as the nine-course certificate program by the American Association for Clinical Chemistry in LC-MS/MS instrumentation can help laboratories keep their staff up to date with LC-MS systems.

 

Conclusion

 

The last decade has seen an incredible growth of LC-MS/MS systems in all phases of drug development. From preclinical drug development to later stages of clinical research, researchers increasingly rely on LC-MS/MS systems to assess toxicology, PK/PD parameters, and many more clinical and non-clinical aspects of drug development. However, advances in method development and validation, standardization experiments, and growth in technical staff are crucial for the sustained rise of LC-MS/MS systems in drug development studies.

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