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>>GLP-Compliant Bioanalytical Services for Novel and Generic Molecules
GLP-Compliant Bioanalytical Services for Novel and Generic Molecules2018-10-21T22:01:39+00:00

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; and
  • Cross Validation.

NUCRO-TECHNICS CAN MEET YOUR SMALL MOLECULE AND LARGE MOLECULE BIOANALYTICAL NEEDS

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.  Our bioanalytical group specializes in rescuing studies where the analytes in question are very challenging to analyze.

Nucro-Technics utilizes state of the art instrumentation to meet bioanalytical challenges and client demands using LC-MS/MS, GC-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.

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.

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For further information about these services, a complete list of services available, to receive a quotation, schedule a test, or if there is something specific that you require, get in touch.