LC-MS method development and validation expertise for Good Laboratory Practice (GLP) bioanalysis studies since 1990
Bioanalytical LC-MS method development for quantitative determination of drugs and their metabolites in biological fluids is crucial during drug development. The need for efficiently generated, regulatory compliant bioanalytical data is reliant on fit-for-purpose methods being developed and validated by experienced LC-MS scientists.
Our bioanalysis LC-MS teams are recognized for the ability to efficiently develop and validate routine and non-routine methods in a wide variety of matrices, and to rapidly employ these assays in a GLP-compliant, high throughput sample analysis environment.
As pioneers in applying this technology to quantitative analysis for Good Laboratory Practice (GLP) studies, our extensive background and expertise combined with a high level of commitment to customer service, have established Intertek as a premier bioanalytical LC-MS resource for the pharmaceutical industry.
LC-MS method development expertise includes:
- Liquid/Liquid, SPE and Protein Precipitation in 96-Well and Standard Formats
- Hydrophilic Interaction Chromatography (HILIC)
- Ion Exchange Solid Phase Extraction (SPE) and Chromatography
- Chiral Analysis
- Analysis of Drugs in Ocular Tissues
- Analysis of Peptides and Pegylated Drugs and Metabolites
- High Throughput Automated Liquid handling Using Hamilton Microlab StarLET Systems
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Bioanalysis and Biopharmaceuticals Webinar Series
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- Drug tolerance in immunogenicity testing
- Comparability studies for biosimilar antibodies
- Bioanalysis and immunogenicity assays for biosimilars
- Regulatory considerations for nonclinical development of antibodies
- Potency testing for a biosimilar antibody