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Preclinical Bioanalysis

Concept Life Sciences' highly experienced scientists work closely with you to ensure a effortless transition through all phases of preclinical bioanalysis. We deliver support from rapid discovery pharmacokinetics (PK) through non-regulatory preclinical toxicokinetic (TK) assessments into formal good laboratory practices (GLP) bioanalysis that underpins TK safety assessments prior to clinical trials.

Concept prides itself on high quality, transparency, and data integrity, assuring the compliance of your regulatory submissions.

Bioanalytical requirements are tailored to support your studies depending on their position in the discovery-development pipeline. If required, method feasibility studies can be performed quickly to provide an indication of how complex method development may be. Common microsampling techniques such as dried blood spots (DBS), capillary microsampling (CMS), Volumetric Adsorptive Microsampling (VAMS) and blood/water can be supported if part of in vivo study design.

Methods are then developed and validated to an appropriate level. This ranges from scientific validations that are suitable for early stage, non-regulatory studies (such as MTD and DRF) through to full regulatory validations (FDA, EMA) required to support TK (dose range finding and maximum tolerated dose) safety studies. Current industry guidelines are rigorously followed, and all regulatory work is performed in accordance with GLP regulations.

A single point of contact seamlessly directs you through the various studies within a project (method development to sample analysis) and all elements are performed to the highest quality to ensure data integrity.

Each study is performed in accordance with a plan and is documented for ease of inspection. We provide standardised and tailored formal reports for method validation studies and sample analysis projects. TK data analysis can also be performed if required.

Preclinical bioanalytical services
  • LC-MS/MS Method Feasibility and Development
  • LC-MS/MS Method Validation in accordance with current industry guidelines and to GLP when required
  • Full support for all pre-clinical studies in all species
  • TK data analysis (WinNonlin) available
  • Microsampling techniques (DBS, CMS, VAMS and Blood/Water) fully supported
Instrumentation and techniques
  • Sciex 6500 and Waters TQS Triple Quadrupoles
  • Sciex QTrap® 6500+ with MRM3 capability for enhanced specificity
  • Waters GS-XS QTof for High Resolution Accurate Mass
  • SelexION™ differential ion mobility technology for increased specificity
  • 2D-ExionLC with multi-dimensional chromatography for increased selectivity
  • On-line radiochemical detection, UV, and GC-MS/FID for analytical support of compounds not amenable to LC-MS/MS
  • Chiral Chromatography
  • Metabolite and multi-analyte methodologies
  • Surrogate peptide approaches in support of large molecule bioanalysis by LC-MS/MS (Proteins, ADCs, etc.)
  • Oligonucleotide analysis

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