Small Molecule Bioanalysis Services for Accurate Results
Discovery, Regulated, and High Throughput Small Molecule Bioanalysis Services. As one of the largest bioanalytical LC/MS service providers in the U.S., we specialize in developing and validating robust bioanalytical methods for the quantification of API and metabolites in various biological matrices, using LC/MS (HPLC, UPLC, 2-D chromatography), HPLC/UV, and HPLC/Fluorescence techniques. We provide industry-leading small molecule bioanalysis for drug development including an extensive suite of DMPK service offerings.
Method development & validation for small molecule bioanalysis
We provide discovery bioanalysis (non-GLP), regulated bioanalysis, and high-throughput bioanalysis for small molecules to support the following therapeutic development studies: develop, validate, and perform laboratory developed tests (LDTs) and FDA-cleared assays.
- Discovery PK studies
- Toxicokinetic studies
- Pharmacology studies
- Clinical studies (Phase I-IV)
- Tissue distribution studies
- Drug-drug interaction studies
- Bioavailability/Bioequivalence studies
- DMPK and Metabolism studies
Bioanalysis for small molecules
- Method development, GLP validation, and transfer, using LC/MS (HPLC, UPLC, 2-D Chromatography), HPLC/UV, and HPLC/Fluorescence techniques.
- GLP sample analysis and clinical sample analysis, to support toxicokinetic, tissue distribution, Phase I-IV, clinical pharmacology, drug-drug interaction, and BA/BE studies.
- Method development, using LC/MS, HPLC/UV, and HPLC/Fluorescence techniques.
- Non-GLP bioanalysis and pharmacokinetic (PK) screening, to assist with lead candidate selection decisions and to support discovery PK and early preclinical studies.
- Methods can later be adapted and validated for regulated preclinical and clinical studies.
- For sponsors needing high-throughput bioanalysis of clinical study samples, we have 25 LC/MS systems, most coupled with UPLC systems, and the capacity to inject at least six plates of samples unattended.
- Model dependent or model independent PK/TK analysis of bioanalytical data from discovery, preclinical, GLP toxicology, and clinical studies.
Non-proprietary assays for small molecule bioanalysis
BioAgilytix San Diego has developed over 2,400 proprietary and non-proprietary methods, including many validated and ready-to-validate non-proprietary assays for small molecule bioanalysis. View our off-the-shelf assay menu.
Equipment and software for small molecule bioanalysis
BioAgilytix San Diego occupies 34,000 square feet of office and laboratory space. Our cutting-edge instrumentation and facilities allow us to increase sample throughput and perform complex separations. Our LC/MS systems and diverse sample preparation technologies allow us to efficiently and accurately analyze large quantities of samples for clients who need high-throughput bioanalysis of clinical study samples.
MicroConstants is now BioAgilytix San Diego
For more than 25 years BioAgilytix San Diego, formerly MicroConstants, has been serving the growing biotechnology community on the west coast.