Bioassay

Human Cell Line Activation Test for skin sensitization testing.

Cell-based potency determination via cAMP detection using validated TR-FRET methodology designed for biosimilar development, batch release testing, and stability evaluation under GMP conditions.

Flow cytometry based analytical method for measuring antibody binding to spike protein after transfection, suitable for batch release and stability evaluation under GMP conditions.

Potency testing for veterinary pharmaceuticals under veterinary Good Manufacturing Practice (GMP) license according to Art. 88 of Regulation (EU) 2019/6.

Customized, product-specific potency assays in accordance with US FDA, EMA, and ICH standards for market release and compound ranking.

Potency testing services for veterinary biologics under veterinary Good Manufacturing Practice (GMP) license according to Art. 88 of Regulation (EU) 2019/6.

A panel of assays designed to help mitigate off-target interactions and achieve optimal specificity from new biotherapeutic drugs, including monoclonal antibodies and recombinant proteins.

Determination of biological activity of G-CSF (Filgrastim) using a validated method according to the European Pharmacopoeia with GMP-certified execution.

Preclinical nephrology disease models for efficacy and safety evaluation.

Potency and functional assay services for human Growth Hormone (hGH).

Cell-based potency determination assay using BAF3 cells with overexpressed huEpoR receptors, measuring ATP production after receptor activation for GMP-compliant batch release and stability evaluation.

Analytical testing services using advanced instrumentation including Waters Alliance HPLC devices for bioanalytical method development, validation, stability assessment, and dose formulation analysis.

Potency and functional assay services for Erythropoetin (EPO).

Cell-based potency assay service for the determination of biological activity of recombinant human Growth Hormone using the NB2-11 cell line.

Immunotoxicity testing services using the ITOX3-Panel.

Characterization of monoclonal antibodies, hormones, and cytokines using in vitro and in vivo platforms to identify dose, mode of action, and mitigate off-target interactions.

Immunophenotyping and flow cytometry analysis services including T, B, and NK cells detection, cellularity index calculation, and in vivo analysis in rats.

Determination of biological activity of erythropoietin by quantitative reticulocyte counts in flow cytometry according to the European Pharmacopoeia monograph.

Standardized safety assay formats for chemical and cosmetic products supporting the development and manufacture of pharmaceuticals and specialized healthcare products.

Complement-dependent cytotoxicity (CDC) potency assay service for Rituximab using Ramos cells.

Flow cytometry and microtiter plate-based ADCC bioanalytical testing services for therapeutic antibodies, featuring purified and genotyped natural killer effector cells and comparative potency testing.

Qualitative and quantitative analysis conducted under both GMP and non-GMP conditions using high-sensitivity HPLC equipment.

Skin sensitization testing service following OECD guideline 442B utilizing a non-radiolabelled 5-bromo-2-deoxyuridine (BrdU) ELISA method for measuring lymphocyte proliferation.

KeratinoSens assay for skin sensitization testing.

Local Lymph Node Assay (LLNA) services for skin sensitization testing.

Buehler skin sensitization assay for chemicals.

Direct Peptide Reactivity Assay for assessing skin sensitization potential.

Local Lymph Node Assay for chemical skin sensitization testing.

Custom fluorescence-activated cell sorting (FACS) bioanalysis services.

Custom cell proliferation and signal transduction assays for cosmeceutical characterization.

Custom cytotoxicity evaluation services for cosmeceutical products.

Acute oral toxicity testing service.

Dermal irritation testing service for chemicals.

Dermal toxicity testing service for chemicals.

Skin irritation and corrosion testing using Reconstructed Human Epidermis.

Eye irritation testing service for chemicals.

Eye irritation testing using Reconstructed human Cornea-like Epithelium.

Custom bioactivity assay development for cosmeceutical products.