Intertek pharmaceutical services provides a range of advanced techniques and expertise to address bio-pharmaceutical aggregation of products, from the development stage onwards. Biopharmaceutical aggregation, either by physical association or by formation of covalent bonds, can have serious implications for the clinical safety and efficacy of a biopharmaceutical medicine. These aggregates can form at any stage of the development and manufacturing process.

Efficacy or loss of activity can be severely compromised by aggregation, e.g. if the active sites become masked as a result of aggregation behaviour. Analytical assay is required to study the biopharmaceutical aggregation behaviour of the product.

As part of the suite of biological macromolecule characterisation techniques, Intertek ASG offers advanced techniques to address aggregation issues:

• 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)
• Analytical
• Ultracentrifugation*
• Circular Dichroism*
  *CD and AUC data is generated by a partner laboratory and following QA audit can be included in formal regulatory studies.

GMP Services:

• All techniques carried out in-house are available as part of GMP Studies.

Additional Resources and Expertise:

• Acces to a UK Consortium to help develop technology to address Detection of Aggregation in Biopharmaceutical Processing.
  

Class 2 Biohazard facility:

• Intertek ASG handles Class I and Class II Biological Agents such as live viral vectors used in vaccines and gene therapy products, as stated within the European Community Directive - Classification of Infectious Biological Agents by Risk Group (2000/54EC).

Biopharmaceutical Characterisation:

• Intertek ASG is highly experienced in the biophysical characterization of a diverse range of biopharmaceuticals and has undertaken detailed comparability studies. There is a regulatory expectation that “orthogonal” approaches will be applied such that conclusions for key quality attributes are based on multiple technologies to address primary structure, post-translational modifications, secondary, tertiary and quarternary structure.

• GMP Pharmaceutical Laboratories