Analytical Capacities and Quality Control

Biomay offers assay development and validation as well as product stability testing in addition to analytical release testing and in-process controls normally included in contract manufacturing arrangements at Biomay. All methods comply with Ph. Eur. standards and a certified QP is responsible for the release of drug substances or products. 

The following analytical methods are used 

• Electrophoresis: SDS-PAGE (coomassie / silver stain), Agarose Gel Electrophoresis
• Chromatography: RP-HPLC, AEC-HPLC, HP-SEC
• Spectroscopy: UV-VIS, Mass Spectrometry, Circular Dichroism, Dynamic Light Scattering
• Immunochemical methods: ELISA, Western Blot, Dot Blot
• Microbiological methods: bioburden, viability, plasmid retention, phenotypic identification
• Host Cell Impurities: Endotoxins, E.coli host cell DNA, E.coli host cell protein
• Other (bio)chemical methods: DNA sequencing, restriction mapping, N-terminal sequencing, peptide mapping, raw material testing