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