Protein Aggregation State Characterization
Intertek provides protein aggregation analysis for all stages of product development.
Protein aggregation, either by physical association or by the formation of covalent bonds, can have serious implications for the clinical safety and efficacy of a protein therapeutic. Such aggregates can form at any stage of the development or manufacturing process. Efficacy or loss of activity can be severely compromised by aggregation, especially if the active site(s) become masked due to aggregation behaviour. Intertek services are offered in line with the requirements of the ICH Q6B guidelines.
Advanced Analytical Techniques
- SEC
- SEC-MALLS
- SEC-Viscometry-RALLS
- Dynamic Light Scattering
- Zeta Potential
- Electron Microscopy (TEM and SEM)
- CE (CZE, MECC, Gel CE, cIEF)
- Gel Electrophoresis (Native, SDS-PAGE, IEF)
- Circular Dichroism*
(*CD data is generated with a partner laboratory - Intertek includes the QA audit for formal regulatory studies).
All techniques above are available as part of a cGMP compliant program. Intertek also has access to a UK Consortium that helps develop technology to address detection of aggregation states in biopharmaceutical processing. We are equipped to handle Class I and Class II Biological Agents (e.g., live viral vectors used in vaccines and gene therapy products).
Related Services
Request more information to see how Intertek can help your organization with Protein Aggregation State Characterization.