VelaLabs has proven expertise in supporting preclinical and clinical trials and in-vitro studies that demand specialized analytical services with results important for the evaluation and interpretation of e.g. bioequivalence, pharmacodynamics, immunogenicity or pharmacokinetic studies.
Whereas for drug product or drug substance characterization well-defined buffers facilitate assay set-up, analysis of samples contained in various biological matrices like blood, serum or urine is more complex and challenging. Furthermore, regulatory bodies require that the influence of the particular biological matrix on the test results needs to be investigated.
VelaLabs offers a broad analytical portfolio ranging from ELISA, electrochemo-luminescence approaches, FACS, PCR, and cytokine pattern analysis (LUMINEX & MSD) technologies to Surface Plasmon Resonance (SPR) based methodology.
An example for SPR is to monitor the generation of Anti-Drug Antibodies (ADAs) and the subsequent characterization of such ADAs regarding isotype and their neutralizing potential.
Our approach in this case consists of the steps screening assay, confirmation assay, titer determination (if mandatory) and finally an (cell-based) in-vitro neutralization Assay.