About us

We are a laboratory focused on the development, validation, transfer, and execution of routine bioassays in pharma & biotech industries. We have both an in vitro and in vivo testing platform to evaluate your products according their MoA.

Our team have over 30 years of experience in the industry working with the Center for Molecular Immunology.  We have developed assays for biosimilars, growth factors, cytokines, monoclonal antibodies, and cancer vaccines. Our laboratories have been inspected by several regulatory agencies. We have an experienced and highly qualified staff that allows us to provide analytical services under GMP & GLP standards and following the guidelines issued by International Council for Harmonization (ICH).

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.