BIOANALYSIS

Pharmacokinetic
Swiss BioQuant AG specialises in top-notch bioanalytical testing. The most modern analysis technology (LC-MS/MS) and equipment is used, which allows routine tests that extend into the lower pg/mL concentration range. The capacity allows for approx. 1500 samples daily.

Our bioanalytical service is focused in the following fields:

• Method development for biological matrices (plasma, urine, CSF, etc...)
• Method validation according to the ICH M10 Bioanalytical method validation and FDA guidance  - Bioanalytical method validation
• Bioanalysis for non-clinical studies: PK and TK studies in plasma, urine, tissues etc.
• Bioanalysis for clinical studies: Bioavailability, bioequivalence and interaction studies

Drug-Protein Binding

Swiss BioQuant employs the following methods to determine unbound drug concentration in plasma, serum, or tissue:

• Equilibrium dialysis
• Ultrafiltration
• Ultracentrifugation

The drug-protein binding can be performed using plasma or tissue sample which is first spiked with the test item at one or more concentrations and then incubated for a prescribed period of time. Alternatively incurred samples from clinical or toxicology studies can be used instead. The unbound concentration is then determined using one of the above mentioned assays followed by LC/MS/MS analysis. Equilibrium dialysis can be performed with the RED device.
Protein binding can also be assessed for individual proteins such as:

• Human serum albumin
• Human α1-acid glycoprotein
• Human sex hormone binding protein

Nanoparticles / Liposome Drug analysis

Liposomes as drug delivery systems exhibit different distribution and pharmacokinetics than free drug molecules. As for all other drug applications validated bioanalytical methods should be available when evaluating the pharmacokinetics and bioavailability of a liposome drug.
Additional validation work and stability investigations
Separation of capsulated and unencapsulated drug

• A second assay needs to be validated, one for the encapsulated drug and the other for the unencapsulated drug.
• A more sensitive method is required for the unencapsulated drug and even more challenging for the free non-protein bound drug.
• Additional QC samples with encapsulated drug to investigate matrix effects.
• Freeze-and-thaw cycles may change the free drug concentration.
• Bench top stability (release) of the liposomal drug in matrix.

Dried Blood Spot Analysis

Long time experience with dried blood spot analysis for antimalarials and other drugs. The analysis of dried blood samples (DBS) offers an innovative option for sample collection and analysis in bioanalytical research. This method enables easy, cost-effective handling and transportation of samples with minimal storage conditions.
In addition, DBS technology reduces the need for larger blood samples and reduces the risk of infection. The precise quantification of analytes in small sample quantities makes dried blood analysis particularly valuable for clinical studies and therapeutic monitoring.