Analytical Development

MABION offers analytical development services integrated as part of a comprehensive development and manufacturing program, but also as standalone services.

Services offered

•    Development of analytical methods for release
•    Development and execution of characterization methods
•    Extended characterization of reference material
•    Comparability studies
•    Purification and characterization of minor species (isomers, impurities
and degradants)
•    In-process support during process development
•    Validation of any analyttical method, incl. bioassays

Analytical Methods

Purity

•    SDS-PAGE (CS and SS)
•    IEF
•    Densitometry
•    Ion-exchange HPLC
•    Size-exclusion HPLC
•    Reversed-phase or hydrophobic interaction HPLC
•    Host cell protein (HCP) ELISA
•    Residual DNA, the most sensitive – fluorescence based method
•    Endotoxin

Primary Structure

•    Western blot
•    ELISA
•    Peptide mapping for detailed primary sequence analysis by LC-MS/MS
•    Characterization of post-translational modifications by LC-MS/MS

Carbohydrate Analysis 

•    Monosaccharide composition analysis
•    Detailed glycan structural analysis by ESI-MS/MS

Functional Assays

•    Cell-based bioassays, incl. CDC, ADCC, apoptosis, proliferation
•    Binding ELISA
•    Binding flow cytometry, quantitative
•    Fc dependent functions ELISA

Protein Mass

•    High-resolution intact protein mass measurement by LC-ESI-MS

Conformational Analysis

•    Circular dichroism (CD)
•    Fluorescence

Aggregation Analysis

•    Size-exclusion chromatography FPLC, HPLC

Physical Properties

•    pH
•    Conductivity

Process Residuals

•    HPLC, ELISA, or LC-MS/MS, including surfactants, methotrexate
•    Protein A
•    Host cell protein (HCP)
•    Residual DNA
•    Endotoxin
•    Particles