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Bio-Analytical Services

Bio-Analytical Services

Bioanalysis: Small Molecules

Mavens’ bioanalytical group specializes in the creation, validation, and analysis of quantitative LC-MS/MS methods. For substances in preclinical (toxicology) and clinical development, bioanalytical services are frequently offered. For discovery research, fit-for-purpose bioanalytical procedures are created. For investigations undertaken for regulatory submission, GLP-compliant bioanalysis utilizing fully validated methodologies is performed.

The team has a lot of experience in developing sensitive LC-MS/MS techniques for multi-analytes, metabolites, pro-drugs, photo/temperature-sensitive, and ex-vivo unstable substances. For rodents, non-rodents, and humans, analytical procedures for new chemical entities are routinely established and validated.

Mavens can provide clients with timely bioanalytical services for both routine and difficult investigations because to its expert technical personnel, advanced test equipment, Watson LIMS system (21 CFR Part 11 compliant), on-site Quality Assurance (QA), and extensive experience in the field of bioanalysis.

Our expertise and competencies include the following:

  • Development and validation of bioanalytical methods for over 300 substances.
  • Bioanalytical services to support FDA, EMEA, MHRA, and other global regulatory filings, as well as other research requiring analytical support.
  • Ability to develop and verify bioanalytical techniques with picogram-level sensitivity using cutting-edge LC-MS/MS and HPLC apparatus.
  • Method development for non-GLP bioanalysis that is fit for purpose.
  • Precipitation, liquid-liquid extractions, and solid-phase extractions are all used to process samples.
  • Capability for derivatization techniques, including method development and validation (e.g. for poorly ionizable chemicals).
  • Quantification of analyte/metabolite(s) in biological matrices such as plasma, serum, and blood samples in accordance with current USFDA, EMEA, and other regulatory regulations.
  • Other matrices for which you have developed procedures include urine, faeces, CSF, bile, and various tissue homogenates.
  • To support preclinical bioequivalence investigations, GLP bioanalysis is being used.
  • Specialized formulations, such as liposomes, are a plus.
  • Capability for bioanalytical quantification of analyte and/or metabolite(s) in clinical trial samples for Phase I through Phase III trials. Experience designing bioanalytical methods for specialty formulations such as liposomes, plant extracts, nutraceuticals, and other specialised formulations.
  • Watson LIMS is a data management system that complies with 21 CFR Part 11.

Software

  • Watson LIMSTM
  • Phoenix WinNonlin
  • Magellan

Bioanalysis: Biopharmaceuticals

For innovative biologics and biosimilars, Maven provides bioanalytical services, including regulatory and non-regulatory in vitro and in vivo studies.

Services:

Currently, Maven has the following capabilities: 

capability for method creation and validation in accordance with GLP regulations.

  • Commercially available ELISA kits were used for validation.
  • ELISA-based peptide and protein bioanalysis capability.
  • Using the ELISA platform, fit-for-purpose bioanalysis for biologicals is possible.
  • Microplate reading technology for ELISA assays is up to date (absorbance, fluorescence and luminescence).
  • Neutralizing antibody assays, as well as immunogenicity/antigen-antibody assays.
  • Biomarker assays capability.
  • Identification and measurement of biomarkers