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Aggregation Analysis & Structural Assessments

Life Sciences / CDMO/CRO Services / Biologics / Analytical Characterization / Aggregation and Structural Assessments

Structural Assessments and Proactive Aggregation Monitoring

During early drug development, it is critical to determine if your biologic protein is prone to self-association. Protein aggregation can cause activity loss of the drug substance and post immunogenicity risks on administration, threatening your drug development process. Formulation, processing, and contact material changes have the potential to trigger aggregation, but routine aggregate analysis and monitoring helps detect issues before they compromise progress.

While reversible associations present transient interactions, irreversible aggregation poses permanent challenges. High protein concentration and formulation conditions such as pH and ionic strength shift the equilibrium toward forming irreversible aggregates. Our early assessment of your biologic protein’s propensity for aggregate formation enables you to implement analytical techniques that ensure efficient and effective formulation development.

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Protein Aggregation Analysis

Secondary Structure
  • Near UV and Far UV Circular Dichroism
Thermodynamic Stability and Unfolding
  • Tm and Tonset by DSC
  • Tm and Tonset by DSF
  • Tagg by DLS
  • Surface hydrophobicity by HIC
Soluble Complexes/Aggregates
  • Dynamic Light Scattering (DLS)
  • Nanoparticle Tracking Analysis (NTA)
Subvisible Particles
  • Micro Flow Imaging (MFI)
  • Light Obscuration by HIAC
  • Light Microscopy

Integrated Laboratory Services 

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.