Study & Technical sheets

Bioassays

Quality Assistance is specialised in the development and/or optimisation, validation and transfer of a very wide range of potency assays.

Luminex

Multiple biomolecules quantification in biological fluids

Cytokine Release

Comparison of multiplex and simplex assays

PEGylated Proteins

In addition to all the analytical tests proposed for proteins, Quality Assistance has developed specific methods for the analysis of PEGylated proteins.

In-use stability studies

Absolute quantification of proteins by ICP/MS

Fast and accurate assay of single proteins by isotope dilution ICP/MS without the need of reference substance

Flow Cytometry

Flow cytometry is a technology that simultaneously measures and analyses multiple physical characteristics of single particles as they flow in a fluid stream through a beam of light.

High Performance NCE Bioanalysis

High Sensitivity and High Throughput Bioanalysis of New Chemical Entities (NCEs)

Batch testing

Comprehensive range of physicochemical, biological and microbiological QC testing

Elemental Impurities

We offer consultancy for risk assessment and state-of-the-art expertise to perform the required analyses.

Bioanalysis

We offer methods to characterise the PK and immunogenicity of your product.

Capillary electrophoresis

Capillary Electrophoresis has become a method of choice in R&D for molecular characterisation and in Quality Control for the release of therapeutic molecules.

Peptide Mapping

The method of choice for fine characterisation of proteins

Analytical Development

Sound expertise for the development, transfer and validation of analytical methods

Protein aggregation

Protein aggregation is a major concern for biotherapeutics as the aggregates may compromise the safety and efficacy of a drug product.

Immunogenicity

Centralized solutions for the assessment of the potential immunogenicity of your product

Immunoassays

Expertise in developing, validating and performing a wide spectrum of different antibody-based assays for different stages of (bio)pharmaceutical product development.

Stability studies

We are able to support you on the long term for stability studies related to clinical trials application, product licence application and post-approval monitoring.

Glycosylation

Quality Assistance analytical platform for the Physicochemical characterisation of Glycosylated Proteins