Protein Aggregation State Characterization

Protein aggregation state characterization supporting all stages of product development to assess the extent of aggregation of proteins in solution

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 where aggregates include dimers and higher multiples of the desired protein product. Potency or efficacy can also be severely compromised by aggregation.

Our experts apply a range of analytical techniques in order to identify and quantify the aggregates in solution. We are experienced in the selection of suitable techniques to address the wide range of aggregation problems that can arise during formulation development and the manufacture of protein pharmaceuticals. Intertek services are offered in line with the requirements of the ICH Q6B guidelines and conduct studies in accordance with either Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP).

Protein Aggregation Analytical Techniques:

  • Size exclusion chromatography (SEC, SEC-MALLS, SEC-Viscometry-RALLS)
  • Dynamic light scattering (DLS)
  • Zeta potential
  • Electron microscopy (TEM and SEM)
  • Capillary electrophoresis CE (CZE, MECC, Gel CE, cIEF)
  • Gel electrophoresis (Native, SDS-PAGE, IEF)
  • Circular dichroism (CD)

All techniques above are available as part of a cGMP compliant program. Intertek is equipped to handle Class I and Class II Biological Agents (e.g., live viral vectors used in vaccines and gene therapy products). Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.

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+44 161 721 5247