Bioanalytical

From RUO Discovery to Fully Validated GxP Bioanalysis

Our bioanalytical services expertise provides quantitative measurements on a range of active drugs, from small molecules to peptides, as well as metabolites. We can perform analysis in complex biological matrices such as plasma, serum, urine, feces, bile, and tissue. All Bioanalytical projects, from the simplest sample management and analysis to the most complex method validation, are approached with a focus on accuracy, precision, efficiency, and speed.


Bioanalytical Technology

  • Waters Xevo TQ-S
  • Thermo Scientific LTQ Orbitrap XL
  • AB Sciex 4000 QTRAP
  • AB Sciex API 4000
  • Waters Acquity UPLC
  • Leap CTC Analytics Autosamplers
  • Tomtec Quadra 96 robotic sample prep workstation
  • Conventional HPLC with UV detection
  • Fluorescence detectors
  • Scintillation counters

We offer a full range of bioanalytical services supporting drug discovery to all stages of clinical phases to pinpoint the detection of your compound


Bioanalytical Capabilities

We offer Research Use Only, GMP, GcLP, and GLP method development, validation, and sample analysis, with the rigor required to satisfy regulatory agencies. We routinely provide bioanalysis for compound screening, preclinical pharmacokinetic (PK), toxicokinetic (TK) studies, biomarker and cytokine analysis, and sample analysis for human clinical trials. We specialize in supporting cell and gene therapy studies including biodistribution, shedding analysis, NAb and ADA testing, as well as cellular immunogenicity. We have the capacity to support small to large scale projects.

Clinical/GLP Bioanalysis

Validation of bioanalytical methods follows the May 2018 U.S. Food and Drug Administration (FDA) “Guidance for Industry: Bioanalytical Method Validation” and the Absorption Systems Standard Operating Procedure (SOP) “Validation of Quantitative Bioanalytical Methods for Determination of Test Compounds and/or Their Metabolites in Biological Matrices.”

GLP bioanalysis also follows the FDA Good Laboratory Practices (GLP) regulations (21 CFR Part 58) and the OECD Principles of Good Laboratory Practice. In addition, all studies follow our own relevant SOPs.

Electronic Reporting and Documentation

LC-MS/MS data is generated using Analyst® Version 1.6.3 compliant with 21 CFR Part 11, and all customer reports are archived in a validated eQCM by Xybion database compliant with 21 CFR Part 11.

In Vitro Services

  • Enzyme Activity Assays 
  • Molecular Biology Testing
    • Transduction Efficiency / Infectivity
    • Biodistribution
    • Viral Shedding
  • Immunogenicity Testing
  • Biomarker and Cytokine Analysis
  • Cell Based Assays
    • Potency GMP Lot Release Assays
    • Proliferation Bioassays using Various Cell Types
    • Cell Viability and TCID50 Titer
    • Compound Screening

Species

  • Mouse
  • Dog
  • Rabbit
  • Pig
  • Mini Pig
  • Sheep

Dose routes

Equipment & Instruments