Intertek ASG Laboratory, Manchester, UK

Biopharmaceutical Aggregation Studies

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. An adverse immunogenicity response to the product could take weeks, months or even a year to develop and so it is important to study aggregation early in the development process prior to clinical studies. Whilst not all aggregates break the immunotolerance it does depend on the type of aggregate, the dose, size and structure. Analytical assay is required to link the structure to immunogenicity.

As part of the biological macromolecule suite of characterization techniques, Intertek ASG can offer a number of advanced techniques to address aggregation issues:

Size Exclusion Chromatography (SEC)
SEC - Multi Angle Laser Light Scattering (SEC-MALLS)
SEC - Viscometry - Right Angle Laser Light Scattering (SEC-Viscometry-RALLS)
Dynamic Light Scattering (DLS)
Zeta Potential
Electron Microscopy
- Transmission Electron Microscopy (TEM)
- Scanning Electron Microscopy (SEM)
Capillary Electrophoresis (CE)
- Capillary Zone Electrophoresis (CZE)
- Micellar Electrokinetic Capillary Chromatography (MECC)
- Gel Capillary Electrophoresis (Gel CE)
- Capillary Isoelectric Focussing (CIEF)
Gel Electrophoresis
- Native
- Sodium Dodecyl Sulfate - Polyacrylamide Gel Electrophoresis (SDS-PAGE)
- Isoelectric Focussing (IEF)
Analytical Ultra Centrifugation (AUC)†
Circular Dichroism (CD)†

GMP Services

All techniques carried out in house are available as part of GMP studies.

Class 2 Biohazard Facility

Our Class 2 Biohazard facility allows studies on live viral vectors used in vaccines and gene therapy products. Intertek ASG has the capability to handle Class I and Class II Biological Agents, as stated within the European Community Directive - Classification of Infectious Biological Agents by Risk Group (2000/54EC).

Collaborative Projects

As part of a multi-disciplinary UK consortium of partners including Avecia, Intertek ASG, Lonza, Paraytec and the University of Bradford has recently been awarded research grants by the Technology Strategy Board and the Engineering and Physical Sciences Research Council. Intertek ASG, working with the University of Bradford, will apply a range of existing technologies to the study of aggregation states in materials supplied by the consortium partners.

For more information see: