Bioanalytic

A critical component of efficient drug development is prompt and accurate analysis of biological samples. Particle Sciences' Bioanalytic group supports both our in-house drug development efforts and stand-alone projects. We are FDA registered and DEA licensed for all schedules of controlled substances. Our facility is cGLP/cGMP compliant and routinely analyzes samples for drug candidates and their metabolites in virtually any biological matrix in support of preclinical pharmacodynamics, pharmacokinetics, toxicological research, and clinical programs.

Our experienced team has decades of bioanalytical method development and LC/MS/MS experience. Our scientists are capable of rapidly solving complex bioanalytical problems by utilizing leading edge technology and state-of- the- art techniques. We develop and validate robust quantitative bioanalytic methods in numerous biological matrices including whole blood, plasma, urine, other fluids and tissues. We apply those methods to high-throughput sample analysis while supporting your GLP and non-GLP studies.

  • Method development and validation
  • Sample analysis
  • Quality assurance
  • Data reporting and management

Particle Sciences conducts bioanalytic method validation and sample analysis in accordance with the FDA Guidance for Industry for Bioanalytical Method Validation, Criteria for acceptability of an assay are stringently adhered to in accordance with the FDA's Guidance and Particle Science's standard operating procedures (SOPs).

Our LC/MS/MS bioanalytic services include:

  • Bioanalytical method development and validation
  • Nonclinical and cGLP/cGMP clinical sample analysis
  • Non-GLP discovery support
  • TK/PK sample analysis
  • Dried blood spot analysis
  • 96-well sample processing and analysis

Instrumentation

  • HPLC, UPLC
  • LC/MS ion trap
  • LC/MS triple quad
  • UV/VIS
  • FTIR
  • Differential scanning calorimetry
  • Microscopic image analysis
  • Fluorophotometer
  • Percutaneous absorption (IVRT)
  • ELISA
  • Gel Electrophoresis