Bioanalytical Assay Development

for LC-MS/MS quantification assays with MRM measurements

Alphalyse provides bioanalytical assay development for analysis and quantification of specific peptides and proteins in biological samples.
Applications:

• Pharmacokinetics (PK) and Toxicokinetics (TK) in pre-clinical animal studies, and in human clinical trials
• Protein biomarker validation and measurements in animal and human biological fluids
• Vaccine and protein biologics manufacturing; in-process control and batch documentation
• Monoclonal antibody development; manufacturing process documentation, pre-clinical and clinical bioanalysis

The development time for quantification assays based on LC MS/MS and MRM measurements is normally 2-4 months. The assays are specific for the peptide analytes, and do not require time-consuming immunization, antibody purification and ELISA development.

The developed assays are qualified for intended use, towards ICH guidelines, including linearity, measurement range, precision and accuracy.

Assay Validation

The quantification assay may be further validated by Alphalyse if the sponsor intends to use the assay and measurements in regulatory documentation to EMEA and FDA. The validation will follow the EMEA Guideline on Validation of Bioanalytical Methods. The validated assay can be used for measurement of pre-clinical and clinical samples in compliance with the OECD Principles of GLP.