LC-MS Sample Bioanalysis
Rapid LC-MS bioanalysis services, delivering reliable results on-time for preclinical studies, through to Phase I and large Phase II-III clinical programs
Rapid LC-MS bioanalysis services are critical to preclinical and clinical programs. Our global expertise in the development and application of efficient LCMS sample preparation and bioanalysis utilizes the latest LC-MS/MS technologies and automated reporting systems, compliant with FDA 21 CFR Part 11.
Our laboratories’ modern LC-MS bioanalysis instrumentation includes Applied Biosystems API 3000/4000/5000/6500™ LC-MS/MS systems, Tomtec Quadra™ 96-Well and Hamilton StarLET sample processing systems. Databases are locked after QA review and can be transferred electronically and securely directly to the client in various formats. Drugs and metabolites are analyzed from a wide variety of biological matrices. The laboratory can process over 15,000 samples per month.
LC-MS bioanalysis lab projects are assigned to and managed by experienced Principal Investigators with support from teams consisting of Project Managers, Project Coordinators, Senior Scientists and Chemists. The project teams ensure your methods are properly validated, and that study samples are accessioned, analysed, and reported in a timely and cost effective manner.
Our scientists and experts deliver reliable results on-time for any project, including sample preparation in LC-MS bioanalysis. These projects range from small preclinical studies and escalating dose studies through Phase I and large Phase II-III clinical programs.
Advanced LCMS Experience
- Liquid/liquid, solid-phase extraction (SPE) and protein precipitation in standard and 96-well formats
- High throughput automated liquid handling for high volume studies
- On-line processing using Cohesive Technologies Aria™ systems
- Analysis of ocular drugs in ocular tissues
- Analysis of peptides and pegylated drugs and related metabolites
- Hydrophilic interaction and ion exchange chromatography
- Chiral analysis
WORKSHOP: How to Build an Inhaler (RDD 2023)
PRESENTATION:E&L Strategies (3rd Annual Extractables & Leachables Conference)
TALK: Medical Device Extractables & Leachables Studies
TALK: ID and sensitivity issues during E&L studies
ARTICLE: Glycosylation Analytical Approaches for Antibody Therapeutics
APP NOTE: Rapid Determination of Low/Trace Level Benzene in Pharmaceutical Excipients and Finished Products
ARTICLE: Importance of Aligning a Pharma Audit Scope with the Correct Standard
TALK: mRNA Analytics: Capping Efficiency, Sequencing, Poly-A Tail, dsRNA
Bioanalysis Services Brochure
Trace Metals Bioanalysis and Biomarker Quantification
White Paper Downloads:
Biomarker Development and Validation
Bioanalysis Of Pegylated Species In Human Plasma By NMR