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
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