Synergy Bioscience has the expertise in developing analytical methods for a wide range of drug products, including chemical molecules and therapeutic protein molecules.
Analytical Chemistry
Services offered
- Development of analytical test methods for release testing.
- Development of chemical characterization test methods
- Comparative test studies
- Purification and characterization of isomers, impurities, and degradants
- In-process support during process development
Analytical Methods
Purity
- SDS-PAGE or capillary electrophoresis-SDS
- Isoelectric focusing (gel-based cIEF or imaged cIEF)
- Ion-exchange HPLC
- Size-exclusion HPLC
- Reversed-phase or hydrophobic interaction HPLC
- Host cell protein (HCP) ELISA
- Residual DNA
- Endotoxin
Primary Structure
- Western blotting
- N-terminal Amino Acids sequencing
- 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
- Sialic acid quantitation
- N-linked glycan profiling (fluorescent HPLC and CE-LIF
- Detailed glycan structural analysis by Orbitrap LC-MS/MS
Functional Assays
- Cell-based bioassay
- Binding ELISA
- Surface plasmon resonance (BIAcore) and isothermal titration calorimetry (ITC)
Protein Mass
- High-resolution intact protein mass measurement by LC-MS/MS
- Intact protein mass measurement by UHPLC
Conformational Analysis
- Circular dichroism (CD)
- Fluorescence
- Fourier transform infrared spectroscopy (FTIR)
Aggregation Analysis
- Dynamic light-scattering (DLS)
- Size-exclusion chromatography with multiangle laser light scattering (SEC-MALLS)
- HIAC liquid particle counting system
Physical Properties
- PH
- Osmolality
- Residual moisture percentage & water content by Karl Fischer measurement
Process Residuals
- Process residual analysis by spectrophotometric assay
- HPLC or LC-MS/MS
- Host cell protein (HCP)
- Residual DNA (qPCR)
- Endotoxin
- Residual Solvents by Headspace GC-FID or GC-TCD
