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