Bioanalysis for Small Molecules

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MicroConstants is one of the largest bioanalytical LC/MS/MS service providers on the West Coast of the United States, housing 15 LC/MS/MS systems and occupying 34,000 square feet of office and laboratory space in San Diego, California.

Our Bioanalytical Chemistry Department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins, peptides, and metabolites using LC/MS/MS (HPLC, UPLC, on-line SPE), HPLC/UV, and HPLC/FL. We have experience analyzing API and metabolites in more than 25 different biological matrices and can provide bioanalytical support throughout all the stages of drug development.

Bioanalytical Services

  • Method development
  • GLP method validation
  • Method transfer
  • Early discovery bioanalysis (non-GLP)
  • GLP sample analysis
  • Clinical sample analysis

Matrices Analyzed

We have experience analyzing API and metabolites in the following biological matrices:

  • Whole blood
  • Serum
  • Plasma
  • Urine
  • Fecal homogenate
  • Spinal cord homogenate
  • Tumor homogenate
  • Aorta homogenate
  • Adipose tissue
  • Skin tissue
  • Brain tissue
  • Muscle tissue
  • Lung tissue
  • Liver tissue
  • Kidney tissue
  • Ocular tissue
  • Vitreous fluid
  • Aqueous humor
  • Synovial fluid
  • Gastric fluid
  • Cerebrospinal fluid (CSF)
  • Bronchial lavage fluid
  • Sputum
  • Endothelial lining fluid (ELF)
  • Bone marrow
  • Perilymph

High-Throughput Screening (HTS) Services

For sponsors needing high-throughput bioanalysis of clinical study samples, we have 15 LC/MS/MS systems and the following automated sample preparation technologies that allow us to analyze more samples, faster, and with better accuracy and precision:

  • 3 Spark Holland Symbiosis on-line SPE systems capable of processing samples with little to no sample preparation by our scientists. Samples are processed during the previous injection’s chromatographic run time. Typical methods will allow automated analysis of 1,000 samples per day or more depending on how quickly the analytes can be chromatographed.
  • 6 Waters ACQUITY UPLC systems capable of increasing sample throughput, reducing solvent use, and performing complex separations more quickly than traditional HPLC systems. Their sample organizers are capable of shuttling up to 22 well plates into the sample manager for analysis, increasing the level of automation and sample processing throughput. Samples processing can be streamlined through 96 well plate SPE or SLE followed by analysis by UPLC coupled with MS/MS detection. The UPLC systems are capable of unattended sample analysis for days allowing night and weekend instrument time to be utilized more effectively.

Types of Studies Supported

We provide discovery bioanalysis (non-GLP), regulated bioanalysis, and high-throughput bioanalysis to support the following therapeutic development studies:

  • Discovery PK studies
  • Toxicokinetic studies
  • Pharmacology studies
  • Clinical studies (Phase I-IV)
  • Tissue distribution studies
  • Drug-drug interaction studies
  • BA/BE studies