Quality Control

The Quality Control platform is in charge of analyzing material produced at all stages of a project : raw material, incoming product, in-process samples, drug substance, drug product, stability samples and environmental monitoring samples.

The Quality Control team works in close collaboration with the Manufacturing and Regulatory Support teams to help prepare the production campaigns and provide relevant documentation for the release of the products.

Our skilled scientists ensure the development of standard or custom controls (see Analytical R&D). Analytical methods are developed/transferred and validated according to ICH guideline. Quality controls commonly proposed are:

Identity

• SDS-PAGE
• IEF
• Western-Blot
• HPLC
• LC-MS
• peptide mapping
• N-terminal sequencing

Purity

• SDS-PAGE
• RP-HPLC
• SEC-HPLC

Purity (process)

• residual DNA
• endotoxin level
• host cell proteins / ELISA
• antibiotic assay
• residual chemicals
• bioburden

Concentration

• RP-HPLC
• ELISA
• Bradford assay
• BCA assay
• enzymatic assay
• absorbance 280nm
• quantitative LC-ES-MS/MS
• quantitative amino-acid analysis
• bioassay

Microbiology controls: cell ID, cell purity, cell viability, plasmid retention
Molecular Biology controls: plasmid ID, plasmid copy number, DNA sequencing