Biopharmaceutical Product Analysis
We provide a comprehensive biopharmaceutical product analysis service to support you in ensuring the identity, purity, stability and quality of your products.
Biopharmaceuticals are complex drugs that require robust scientific data to support submission and, comply with regulatory requirements. The quality and safety of a new biopharmaceutical, a biosimilar or a biobetter product can be impacted by the protein structure, post-translational modifications, physicochemical properties, aggregation, stability and impurities.
Our expert teams have a wealth of experience in protein characterisation, host cell DNA quantification, host cell protein quantification, glycosylation profiling and carbohydrate determination.
Using state-of-the-art equipment and data analysis software, we can determine molecular weights of intact protein molecules. We also conduct peptide mapping of digested proteins for use in protein identification, quantification, sequencing, disulphide-bridge analysis, as well as post-translational modification (PTM) analysis.
Host Cell DNA and Protein
Our expertise can help to ensure that in-process contaminants have been removed, thereby avoiding issues of immunogenicity and toxicity from host cell DNA and protein. We are experts in developing process-related contaminant assays using PCR techniques for DNA and, ELISA techniques for protein.
Glycosylation and Monosaccharide Determination
We can help define the important glycosylation features of your novel biosimilar or biobetter to support pre-clinical and clinical studies, regulatory submission and batch release. Using technical experts, we build up a complete picture of your biopharmaceutical’s glycosylation: structures of individual oligosaccharides, relative amounts, monosaccharide analysis and sites of attachment.
- Peptide mapping
- Post-translational modification analysis
- Intact mass analysis
- Host cell DNA and protein quantification
- Method development and validation
- Glycosylation profiling
- Monosaccharide analysis
Techniques available include:
- Liquid Chromatography-Mass Spectrometry (LC-MS)
- Sodium Dodecyl Sulphate-Polyacrylamide Gel Electrophoresis (SDS-PAGE)
- Capillary Electrophoresis (CE)
- High Performance Liquid Chromatography (HPLC)
- Fast Protein Liquid Chromatography (FPLC)
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Western Blotting
- Quantitative Polymerase Chain Reaction (QPCR)