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Bioanalytical Services - LC/MS/MS Development, Bioanalytical Method Development, Bioanalytical Method Validation

Bioanalytical Services

NUCRO-TECHNICS is an expert provider of contract bioanalytical research services to pharmaceutical and biotechnology companies around the world. These services include:

  • Method Feasibility Assessment
  • Method Transfer between instrument platforms, species and matrices
  • Method Development and Validation
  • Cross Validation

The services provide bioanalytical support for preclinical and clinical studies, including toxicokinetic studies, under both GLP and non-GLP conditions. NUCRO-TECHNICS has extensive expertise in the rapid transition of methods between rodents, dogs and humans. We are experts in projects requiring rapid turn-around times, development of multi-analyte methods (simultaneous measurement of drug and its metabolites) with stellar reproducibility of incurred sample reanalysis.

NUCRO-TECHNICS utilizes state of the art instrumentation to meet bioanalytical challenges and client demands using LC/MS/MS, HPLC or GC instruments to measure drug concentrations in biological matrices such as whole blood, plasma, serum, CSF, urine, and tissue (organs, skin). Our instrumentation allows development of methods that have both wide dynamic range and high sensitivity for precise measurements in low ng/mL range.

In conjunction with our Toxicology department we have developed microsampling and Dry Blood Spot (DBS) analysis. These techniques provide the benefits of better quality pharmacokinetic and toxicokinetic (PK/TK) data and less expensive preclinical studies.  They are more humane towards laboratory animals, simplify sampling, sample storage and shipment.

NUCRO-TECHNICS is proud to also offer an extensive portfolio of protein services (large molecules). These services include both qualitative and quantitative protein workflows. Our exploratory services include intact protein and peptide mass determination, analysis of SDS-PAGE gel bands and analysis of complex protein mixtures. We can help our clients enrich specific proteomes via immunodepletion, immunoprecipitation or crude subcellular fractionation (cell membrane fraction) techniques. We are equipped to perform mass spectrometry structural analysis of specific proteins, looking in-depth for known post-translational modifications or analyze expected sites of drug (small molecule) conjugation. On the quantification side we offer SRM/MRM technology for either relative or absolute quantification. Using this technique we have developed quantification methods for a list of classical hepatotoxicity biomarkers in rat plasma. In addition, for clients interested in protein biomarker discovery, we offer high mass resolution MS1-based quantitation of proteins.

The Bioanalytical department at NUCRO-TECHNICS works in compliance with Good Laboratory Practice (GLP) regulations, the U.S. Food and Drug Administration (FDA), Health Canada, and the Standards Council of Canada (SCC), European Medicines Agency (EMA) and others.

Our highly trained professionals have developed expertise to conduct a great variety of sensitive and specific sample analyses.

For further information about these services, to receive a quotation, or to schedule a test, please contact NUCRO-TECHNICS.