Protein Analysis
We offer in-depth expertise in GLP and cGMP protein analysis.
Intertek services for protein and glycoprotein analysis are offered in line with the requirements of ICH Q6B Guidelines.
Structural Characterization and Confirmation:
- Amino Acid Composition by Ion Chromatography
- Amino Acid Sequencing
- Peptide Mapping using MALDI or Electrospray MS
- Disulphide Bridge (S-S bridge) Maps using MALDI or Electrospray MS
- N-Terminal Sequences by LC-MS/MS Sequencing of Peptide Fragments from Digests
- C-Terminal Sequences by LC-MS/MS Sequencing of Peptide Fragments from Digests
- Post Translational Modification Studies using a Broad Range of Digest Strategies and LC-MS/MS (including enhanced scan techniques)
- Isoform and Impurity Studies using PAGE, SDS-PAGE, IEF, CE, HPLC
- Spectroscopic profiles (including for higher order protein structure)
- Extinction Coefficient Determination
- Molecular Weight
- Basic Activity Assays e.g. Sandwich ELISA, Western-Blot
- Glycosylation Studies by Enzymatic Glycan Cleavage and Fingerprinting by IC or MALDI-MS
- Product related impurity analysis
- Process Residuals Analysis
Advanced Protein Analysis Services
- Comparability Studies for Biopharmaceuticals
- Biopharmaceutical Process and Product Related Impurities Analysis
- Advanced Glycosylation Studies using Multiple Cycles of Selective Enzymatic Cleavage and MALDI-MS to build up a detailed picture of branching
- Studies of Conjugated Products (e.g., Protein-Toxin Conjugates) using LCMS and LC-MS/MS to determine Loading and Binding sites
- Viral Proteome Studies to support the characterization of Viral Products used in Vaccine and Gene Therapy products
Related Pharmaceutical and Protein Services
Request more information to see how Intertek can help your organization with Protein Analysis.