Small and large molecules bioanalysis
Our bioanalysis teams provide precise and timely data using state-of-the-art facilities and instrumentation, expertise in a variety of technologies and methods and scientific experience in regulatory aspects.
Our support to Pharmacokinetic / Toxicokinetic study assays includes method development, validation and sample analysis to measure drug and metabolite concentrations for samples in plasma, serum, cerebrospinal fluid (CFS), urine and tissues. Our comprehensive services can be performed on small molecules and large molecules including: monoclonal antibodies, oglionucleotides, peptides and proteins.
All these activities are performed using:
- LC-MS Assays (UPLC with triple quadrupoles and Q-TOF platforms)
- Ligand Binding Assays (ELISA, RIA, Gyrolab xP, MSD platforms)
- Hybridization assays
- Enzyme Assays
Methods are validated following international guidelines (FDA and EMA).
All bioanalytical activities are performed with the use of automated sample preparation and a validated LIMS system to manage all bioanalytical data.
Aptuit has the capacity to store up to approximately 250,000 samples.
The bioanalytical group also supports CYP identification, CYP inhibition and PPB studies using qualified/validated methods.