Product/Service

GLP/GCP Bioanalysis Services

Source: BASi (Bioanalytical Systems Inc)

BASi offers high capacity GLP/GCP bioanalysis and fast sample analysis turnaround. We have more than 30 years experience providing contract laboratory services to the industry’s leading biotech and pharmaceutical firms.

BASi offers high capacity GLP/GCP bioanalysis and fast sample analysis turnaround. We have more than 30 years experience providing contract laboratory services to the industry’s leading biotech and pharmaceutical firms. More than half of our bioanalytical work supports clinical trials, including drug interaction, ADME, PK and Bioequivalence.

BASi is known for its responsiveness to individual clients, high quality data, scientific talent and exemplary regulatory compliance.

BASi provides GLP/GCP bioanalysis for small and macromolecules from matrices, including blood, plasma, urine and tissues. Method development and validation are our specialties. We have developed a large library of analytical methods; about half are proprietary new drug candidates.

Our laboratories have the capacity to analyze thousands of samples each week. High sample throughput is made possible with LC-MS/MS instruments and automated sample preparation technology.

Through our corporate SOPs, BASi maintains high standards at its three labs in the U.S. and U.K. to ensure consistent, quality data for drug development projects.

  • Customer service - flexible to meet customer requirements
  • Method development and validation for small and macromolecules
  • High-throughput GLP/GCP bioanalysis
  • Non-GLP discovery bioanalysis
  • Combination medical device drug development

 

Three major LC-MS/MS platforms (34 instruments)

  • Sciex QTrap 5500, Triple Quad 5500, API 5000, 4000 and 3000
  • Waters Micromass Quattro Ultima
  • Thermo Finnigan TSQ Quantum Ultra
  • UHPLC, LDTD and conventional HPLC front-ends available

 

Immunoassay robotics and microplate readers

  • Grifols Triturus automated immunoanalyzer
  • Mesoscale Discovery Sector ECL detector 2400 system
  • Molecular Devices SpectraMax M5 microplate readers

 

Automated 96-well sample preparation

  • Tomtec Quadra 96 model 320 systems

 

Conventional HPLC with UV, fluorescence, conductivity and electrochemical detection

Low temperature storage

  • Validated, monitored, and alarmed
  • -80° and -20° C freezer capacity
  • Independent stand-by emergency power systems

 

Up-to-Date IT Infrastructure

  • BASi Projects Database System (proprietary, based on Oracle)
  • Watson LIMS
  • SoftMax Pro GxP
  • PE Sciex Analyst
  • Waters Millenium and Empower
  • PE Totalchrom
  • MasterControl Document Management System
  • Calibration Manager (Calman)