Plan the analytical work with the animal study.
MuriPhys connects study design, dosing and sample collection with bioanalytical support, including coordination with specialist partners. Scope is agreed around the analyte, matrix, assay readiness and intended use of the data.
Bioanalytical workstreams
- Method development, transfer and study-appropriate qualification or validation.
- Quantitative analysis of small molecules and other suitable analytes.
- PK/TK sampling plans, sample handling and exposure analysis, including non-compartmental analysis where appropriate.
- Plasma, serum, CSF, urine and tissue matrices, as agreed for the selected method.
- Metabolite identification, profiling, metabolic stability and pathway characterization using an appropriate platform.
- Tissue distribution and biodistribution study coordination.
- Specialist protein, immunogenicity or molecular assays when included in the project scope.
Select the method for the question.
LC-MS/MS and high-resolution mass spectrometry address different analytical needs. The analytical platform, sensitivity, calibration range, sample preparation and data analysis are defined with the laboratory performing the work. Molecular biodistribution assays, such as PCR-based methods, are scoped separately from mass spectrometry.
Analytical platforms and specialist workstreams
Discuss triple-quadrupole LC-MS/MS, UPLC separations, high-resolution QTOF and automated sample preparation with the performing laboratory. Manufacturer and configuration requirements, including Waters, SCIEX or Thermo systems, are confirmed for the proposed method.
Protein, immunoaffinity-enrichment and anti-drug-antibody workstreams require appropriately scoped methods. PCR-based post-AAV biodistribution is planned separately from LC-MS bioanalysis.
Define responsibilities and deliverables.
Agree on the performing laboratory, method status, sample requirements, shipping and storage conditions, analysis schedule and report package before the study starts. Any regulated or GLP work requires an explicitly agreed scope and an appropriately qualified performing laboratory.