info@advinus.com   

Eurofins | Advinus’ bioanalytical group specializes in quantitative LC-MS/MS method development, method validation and study sample analysis. Bioanalytical services are routinely provided for compounds in discovery, and in preclinical (toxicology) and clinical development. Fit-for-purpose bioanalytical methods are developed for discovery studies. GLP-compliant bioanalysis using fully validated methods developed  are performed for studies conducted for regulatory submission.

The team has extensive expertise in developing sensitive methods for LC-MS/MS, including analysis of multi-analytes, metabolites, pro-drugs, and photo/temperature sensitive and ex-vivo instable compounds. Analytical methods for new chemical entities are routinely established and validated for rodent, non-rodent and human species.

Expert technical staff, advanced test equipment, Watson LIMS system (21 CFR Part 11 compliant), on-site Quality Assurance (QA) and rich experience in the area of bioanalysis enables Eurofins | Advinus to provide clients with timely bioanalytical services for both routine and complex studies.

Our experience and capabilities includes

  • Successful bioanalytical method development and validation of 300 plus compounds.
  • Bioanalytical services to support GLP IND enabling study package for FDA, EMEA, MHRA and other global regulatory submissions, and also for other studies requiring analytical support.
  • Ability to develop and validate bioanalytical methods using state-of-the-art LC-MS/MS & HPLC instrumentation and achieve sensitivity up to picogram levels
  • Fit-for-purpose method development for non-GLP bioanalysis
  • Sample processing using precipitation, liquid-liquid extractions and solid-phase extractions
  • Capability for derivatization approaches (e.g. for poorly ionizable compounds) including method development and validation
  • Quantification of analyte / metabolite(s) in biological matrices such as plasma, serum and blood samples in compliance with latest regulatory requirements of USFDA, EMEA, etc.,
  • Experience with developing methods for other matrices such as urine, feces, CSF, bile and various tissue homogenates
  • GLP bioanalysis to support preclinical bioequivalence studies
  • Experience with specialized formulations such as liposomes
  • Capability for bioanalytical quantification of clinical trial samples for analyte and or metabolite(s) for Phase-I through Phase-III trials. Experience in developing bioanalytical method for specialized formulations such as liposomes, plant extracts, nutraceuticals etc.
  • Equipped with Watson LIMS – 21 CFR Part 11 compliant Data Management System for data

Software

  • Watson LIMSTM
  • Phoenix WinNonlin
  • Magellan

Eurofins | Advinus offers bioanalytical services for novel biologics and biosimilars including regulatory and non-regulatoryin vitro and in vivo studies

Services

Currently Eurofins | Advinus offers

  • Capability for method development and validation to comply with GLP requirements
  • Validation using commercially-available ELISA kits
  • Capability for peptide and protein bioanalysis by ELISA methods
  • Fit-for-purpose bioanalysis for biologicals using ELISA platform.
  • Latest technology for micro-plate reading for ELISA assays (absorbance, fluorescence and luminescence).
  • Immunogenicity/antigen-antibody assays including neutralizing antibody assays
  • Capability for biomarker assays
  • Biomarker identification and quantification