Biacore technology offers label-free assays that provide precise and reliable concentration and kinetic measurement. This can be applied through all stages of product development, from discovery to quality control.
Quality Assistance is specialised in the development and/or optimisation, validation and transfer of a very wide range of potency assays.
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
Determination of the over time stability of the post-diluted drug product
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 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)
Comprehensive range of physicochemical, biological and microbiological QC testing
We offer consultancy for risk assessment and state-of-the-art expertise to perform the required analyses.
We offer methods to characterise the PK and immunogenicity of your product.
Capillary Electrophoresis has become a method of choice in R&D for molecular characterisation and in Quality Control for the release of therapeutic molecules.
The method of choice for fine characterisation of proteins
Sound expertise for the development, transfer and validation of analytical methods
Protein aggregation is a major concern for biotherapeutics as the aggregates may compromise the safety and efficacy of a drug product.
Centralised solutions for the assessment of the potential immunogenicity of your product
Expertise in developing, validating and performing a wide spectrum of different antibody-based assays for different stages of (bio)pharmaceutical product development.
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.