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Biological Information
Aggregates

Characterising Biological Aggregates

Characterisation of protein aggregates involves analysing size, morphology, and distribution using techniques like dynamic light scattering (DLS), Surface Plasmon Resonance (SPR) and Flow Imaging Microscopy (FIM). This helps understand aggregation mechanisms, assess stability, and ensure safety and efficacy in pharmaceuticals, reducing immunogenicity risks and optimising formulation and storage conditions.

Dynamic light scattering (DLS)

Dynamic light scattering (DLS) characterises protein aggregates by measuring their size distribution in solution, providing insights into aggregation state, stability, and polydispersity, crucial for pharmaceutical formulation and quality control.

Surface plasmon resonance (SPR)

Surface plasmon resonance (SPR) characterises protein aggregates by measuring binding interactions and kinetics on sensor surfaces, providing insights into aggregation behavior, affinity, and stability, crucial for therapeutic protein development and quality assurance.

Flow Imaging Microscopy (FIM)

Flow Imaging Microscopy (FIM) characterises protein aggregates by capturing high-resolution images in a flowing sample, allowing precise analysis of size, shape, and concentration, essential for assessing protein formulation stability and quality.

Case study

A biotech firm faced challenges with protein aggregation affecting drug stability. Utilising ViewSizer 3000, they analysed aggregates across a wide size range, obtaining precise size distribution and concentration data. Results guided formulation adjustments, enhancing drug stability and efficacy.

The instrument’s multi-wavelength light scattering accurately detected and sized particles, providing real-time visualization. This enabled informed decisions on storage conditions and formulation optimization. Ultimately, the ViewSizer 3000 facilitated robust quality control measures, ensuring the therapeutic integrity of the biopharmaceutical product.