Innovative technologies for faster quantitative assays for drug discovery and development

V Umasankar, Senior Product Manager—MS, Waters India, speaks about how bioanalytical scientists are using innovative technologies to fulfill the business objectives

In modern drug discovery and development process, LC/MS/MS has become the method of choice for quantitative bioanalytical applications. The development of suitable fast bioanalytical methodology for the sensitive quantification of parent drugs and their metabolites is an essential and highly challenging component of the clinical trials with faster turnaround times.

In general, the pharmaceutical companies and contract research organisations are focused on increasing the revenues, reducing the cost, better asset utilisation and faster completion of projects. To achieve these goals, the need technology would provide: Improved information per unit time; versatile and flexible tools for analysis of complex samples; better quality results for wide coverage of molecules; robust method development and validation; standardised data management and regulatory compliance; manpower training on newer technologies.

The bioanalytical scientists are looking for new innovative technologies with total system solution approach to fulfill the business objectives and goals of the organisation. To develop faster robust method and its validation, the bio analytical scientist has to work on the following process: Faster cleaner sample extracts from plasma; good separation between drug, metabolites and matrix inferences; sensitive and reproducible qualitative and quantitative data; regulatory compliance.

Waters system total solution has many automatic built in functions to get perfect answers to the above process:

a. Sample preparation products for cleaner sample extracts:

• Protein precipitation 96 well plates
• Ostro phospholids removal 96 well plates
• Oasis solid phase extraction with high selectivity

b. Ultra performance Liquid Chromatography (UPLC) offers the following high performance benefits to bioanalytical analysis,

Higher sample throughput

• Increased selectivity and resolution
• Better spectral data and quality information in less time
• Enhanced sensitivity and LOD
• Improved overall efficiency and Productivity

c. Xevo Tandem Quad Mass spectrometer systems with unique features

• Ultimate reproducible quantitative capabilities
• Automated system setup and method development
• Enhanced qualitative capabilities for robust method development by RADAR
• Streamlined quantitative workflow to meet ISR,ISS and MIST guidelines.
• Fully integrated UPLC compatible mass spectrometer. UPLCMSMS.

d. New Genesis Scientific data management software for regulatory compliance and data safety.