Diteba Research Laboratories offers method development, validation, and specimen analysis using state-of-the-art laboratory equipment and techniques, including Ultra Performance Liquid Chromatography Mass Spectrometry (UPLC/MS/MS) as well as liquid and gas chromatography techniques.

We can also develop sensitive and specific GLP-compliant immunoassays to support the study of macromolecules for PK, biomarkers and immunogenicity studies.  The development of bioanalytical methods is tailored to meet specific clinical needs and direct, indirect, capture and competitive ELISA formats are available.

Our scientists have extensive experience developing and validating bioanalytical methods in blood, urine and tissue specimens to support your pre-clinical studies through Phase III clinical trials.  Our bioanalytical services are performed in compliance with GLP and comply with Health Canada and U.S. FDA guidelines.

Our bionanalytical testing services include:

• Feasibility assessments

• Assay method development, validation and transfers

• Expertise in many proven validated methods to quantitatively measure all types of compounds, small or large molecule, using:

  • LC-MS/MS

  • UPLC-MS/MS

  • HPLC-GFC

  • UPLC-UV, Fl, ECD

  • Capillary Electrophoresis (CE)

  • ELISA (Immunochemistry)

  • PhastSystem

  • Gel Image Analysis System

• Bioanalysis of drug and metabolites in biological fluids from pre-clinical and clinical trials by HPLC, UPLC, LC-MS/MS or UPLC/MS/MS

• Metabolite identification using LC-MS/MS

• Sample analysis technologies in multiple biological species and matrices for Pre-Clinical Animal Studies

• Clinical Trials Support:

  • Pharmacokinetic (PK) Analysis

  • Bioavailability Studies

  • Bioequivalence Studies

  • Drug Interaction Studies

• PK & Immunogenicity

  • Pegylated Proteins

  • Fusion Protein

  • Peptides

  • Antibodies

  • Oligonucleotides

  • Polysaccharides