Particle Analysis in Pharmaceutical Applications

Protein Aggregation Detection

Traditionally, particles found in parenteral (or injectable or intravenous) drug formulations have been contaminants such as glass, fibers or dirt. The origin of these particles can vary, but the major sources are packaging materials, manufacturing processes and formulation components. 

However, the introduction and rapid growth of MAb drugs has created a new and different type of particle formed by protein aggregation. Particles formed by protein aggregation range in size from nanometers to hundreds of microns. In the MFI size range of operation, protein aggregates are near-transparent, irregular in shape, fragile and easily deformed. In addition, protein aggregation is not a static phenomenon so particle size and morphology will change in response to age, handling and storage conditions. In fact, the shelf life of many protein-based parenteral drug formulations is determined by their propensity to form aggregates. 

For these reasons, protein aggregates pose a significant challenge to the instrumentation technologies traditionally used for particle analysis in parenteral formulations. 

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Here are some additional useful links on protein aggregation:

• Protein Aggregation and Bioprocessing 
• Protein Aggregation and Immunogenicity Focus Group
• 2007 Colorado Protein Stability Conference