Biologics
Biological API, in-processing materials and finished products are very different from traditional drug substances and products. They include polysaccharides, peptides, proteins (enzymes and antibody product), oligonucleotides and lipids. The method development, material characterization and test in quality control are all unique. With our extensive experience and expertise supporting the biopharmaceutical industry, you can rest assured you’re in good hands.
Biopharmaceutical Characterization Services
We offer product development and testing for:
- Oligonucleotide products, early API quality control, compatibility studies, analytical method development and validation, release testing and stability studies
- Enzyme products, early API quality control, compatibility studies, analytical method development and validation, enzymatic activity test, release testing and stability studies
- Polysaccharides, early API quality control, characterization of composition and sugar mapping, compatibility studies, release testing and stability studies
- Protein/peptides, raw material testing, identification by chromatography, ligand affinity, characterization by peptide mapping, amino acid composition, product formulation compatibility, release testing and stability studies
The following tests can be also offered:
- Amino acid sequencing
- N-terminal sequencing
- Peptide mapping by MS
- Glycosylation analysis
- Aggregation analysis
- Amino acid composition
- C-terminal sequencing
- S-S Bridge analysis
- Electrophoretic profiles
- Post-translational modifications