05/08/2026
Expertise Areas in Biopharmaceutical Quality Control
As a laboratory specialized in quality control and bioanalytical testing, our expertise focuses on the rigorous evaluation and characterization of complex biopharmaceuticals to ensure their potency, safety, and consistency. We master the analytical methodologies applied to three critical categories:
1. Monoclonal Antibodies and Biosimilars: Specialists in the potency analysis and functional characterization of therapeutic antibodies (such as anti-EGFR, anti-CD6, anti-CD20, anti-HER2) and their biosimilars. We perform assays ranging from specific binding quantification to cell-based bioassays that verify the mechanism of action (MoA), which are essential for comparability and batch release.
2. Therapeutic Proteins (Cytokines & Growth Factors): Experts in assessing the biological activity and stability of immunomodulators like cytokines, growth factors (rhEPO, G-CSF), and their analogs (IL-2 muteins), ensuring they meet critical quality specifications.
3. Immunotherapies and Vaccines: We have extensive experience in the preclinical analysis and quality control of vaccines (such as CIMAvax-EGF®) and immunotherapies, including the evaluation of their potency and immune response in relevant biological models.
