Small Molecule Bioanalysis

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.

Bioanalysis for Small Molecules

We provide the following services for small molecule bioanalysis:

  • 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.

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

Studies We Support

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

Non-Proprietary Assays for Small Molecule Bioanalysis

BioAgilytix has developed more than 2,400 proprietary and non-proprietary methods, including many validated and ready-to-validate non-proprietary assays for small molecule bioanalysis.

Equipment and Software for Small Molecule Bioanalysis

BioAgilytix occupies 34,000 square feet of office and laboratory space in San Diego, California. 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.

Featured Case Study

A Non-Traditional Internal Standard

Learn how the development of a non-traditional internal standard by derivatization allowed our client to maintain their rigorous timeline, without resorting to an expensive synthetic effort.

Specimen Collection Kits

BioAgilytix assembles and distributes protocol-specific specimen collection kits to simplify and streamline the PK collection process for single and multi-site clinical trials. Kits are tailored to your specific sampling needs and can be shipped worldwide. The specimen samples collected can be returned to the testing laboratory of your choice for small molecule bioanalysis.

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