Unilabs has a long track of successful assay development and deployment in support of our sponsors:
- Bioanalytical partner for the first registered European gene therapy drug.
- Safety parameters, PK, and PD in a clinical study of the respiratory drugs.
- Bioanalytical partner for orphan drug replacement enzyme study.
- Testing of immunogenicity directed towards viral vectors (AAV).
- Central laboratory services for clinical studies in dermatology studies.
- Multiple clinical trials of arthrosis applying CR techniques.
- Histopathology partner in a study involving screening of prostate cancer.
Download case studies below
Development of high sensitivity bioanalysis assay.
Development, Validation, and Application of a High Sensitivity On-Line Extraction LC-MS/MS Method.
The method was demonstrated to be sufficiently accurate and precise, and to have sufficient selectivity, to reliably allow the determination of the parent, M1, and M2 in human plasma samples over the examined range. The sub pg/ mL LLOQ has provided high-quality PK data from early clinical studies, enabling the rapid progression of the clinical program.
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Development of quantitative peptide bioanalysis method.
The quantitative bioanalysis of peptide drugs is very challenging. Extremely low concentrations after administration are seen due to the high potency of this class of compounds. The methods have been validated in rat and human milk and qualified in rabbit milk. The pg/mL LLOQ has provided high-quality PK data from early preclinical clinical studies, enabling the rapid progression of both programs.