Apply Expert Bioanalysis to Your Drug Development
Gain targeted insights with custom bioanalysis performed by our team to support lead selection and optimization. We offer comprehensive quantitative bioanalytical services across different drug development stages in parallel with our other analytical, formulation development, and manufacturing capabilities. The resulting data informs your product’s behavior during pre-clinical and clinical activities. With robust assays tailored to your needs, our sample analysis results help you make confident, informed decisions for your regulatory submissions throughout the product life cycle.
We also offer bioanalytical method development as well as GLP and non-GLP bioanalysis services to support your needs during the pre-clinical phase of your product. With an early focus on method robustness and expertise in bioanalytical method validation, our scientists readily validate methods under GLP with our highly sensitive and qualified instrumentation.
Method Development
Sample Preparation
Bioanalytical sample analysis plays acritical role in drug and metabolite quantitation within biological matrices to understand pharmaceutical pharmacokinetics, pharmacodynamics, and metabolism. Sample preparation involves extraction or separation of your drug substance or novel excipients from complex matrices such as blood, plasma, serum, cell-culture media, and tissue homogenates.
In the case of tissue samples, we initially optimize the homogenization process. Optimizing sample preparation is a critical phase in method development and aids in improving method sensitivity. We employ a variety of sample preparation techniques including protein precipitation, solid phase extraction, liquid-liquid extraction, cell lysis, and immunocapture. For biologics, combining these techniques with ELISA or LC-MS/MS enables us to develop highly sensitive quantitation methods. We achieve this by selecting unique peptides generated through protease mediated digestion and by using synthetically generated labeled internal standards. In the case of nucleic acids (mRNA or DNA), quantitation is performed using RT-PCR.
Robustness Assessments
By performing preliminary robustness assessments and having appropriate controls in place, we ensure accurate quantitation of your molecule of interest in your samples. Moreover, verifying selectivity and performing limited stability assessments aids in establishing suitable criteria for method validation.
Bioanalytical Services
We specialize in developing targeted bioanalytical methods using highly sensitive LC-MS/MS systems. Our scientists employ a variety of sample preparation techniques catering to the analyte chemistry (polar/non-polar) and type of matrices, including blood, plasma, urine, tissue homogenates, etc.
With a bioanalytical method in place, our team quickly analyzes your test samples (blood, plasma, urine, tissue homogenates, serum, cell culture media, and more) using our highly sensitive LC-MS/MS systems to help you understand the behavior of your molecule in vivo and inform pre-clinical candidate selection.
Clinical and non-clinical sample analysis under GLP regulations is critical for filing PK and TK reports for your drug product. We routinely analyze GLP samples while maintaining quality standards per FDA regulations. We customize your sample analysis reports as requested to allow easy transfer of the data into your P/TK reports. We also have the capabilities to transfer an existing validated method quickly for analyzing your GLP samples. We are highly focused on data integrity and maintaining quality standards to ensure that the sample analysis is performed under full GLP compliance.
Operating within a regulated GLP environment, we provide bioanalytical method validation services according to FDA’s bioanalytical guidance document for chromatographic assays. Our highly trained scientists perform extensive method robustness assessments prior to validation. This testing helps minimize variability during validation and GLP sample analysis. Then, our quality team ensures that the validation is performed under GLP compliance.
We perform in vitro half-life analysis of drug substances or novel excipients in liver S9 fractions and plasma using our highly sensitive LC-MS/MS systems. We also provide metabolite characterization services to ID the metabolites using our high-resolution LC-MS systems.
Diverse Molecular Support
Small Molecules
Achieve important milestones by partnering with our team to identify molecular candidates with the best chances of success, providing crucial insights for confident decision-making.
Biologics
Power your project with informed decision-making through comprehensive analysis supported by our team.
Nucelic Acids
Establish a comprehensive foundation for your nucleic acid-based therapeutic with help from our highly experienced team.
Novel Molecules
Break away from traditional approaches to pharmaceutical development with support from our expert team.