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Aggregation Kinetics Analysis

Aggregation kinetics analysis is a critical component of biopharmaceutical development, providing essential insights into the time-dependent aggregation behavior of therapeutic proteins, peptides, monoclonal antibodies, and other biologics. Aggregation can impact drug stability, efficacy, and immunogenicity, making precise kinetic analysis crucial for formulation optimization, quality control, and regulatory compliance. Our advanced analytical services offer precise, reproducible aggregation kinetics measurements to support pharmaceutical development and stability studies.

Illustration of steps involved in protein aggregation of a monomer. (STEMart Original)

Analytical Techniques

Dynamic Light Scattering (DLS)

DLS is one of the most commonly used techniques for monitoring changes in the size distribution of nanoparticles or macromolecules in solution over time. During aggregation kinetics analysis, DLS is employed to measure the hydrodynamic size of protein aggregates as a function of time and concentration.

What It Measures:

  • Hydrodynamic diameter (Z-average) of aggregates
  • Changes in aggregate size over time
  • Rate of aggregate formation and growth

Static Light Scattering (SLS)

SLS measures the intensity of light scattered by particles in solution, which is directly related to their size and molecular weight. In aggregation kinetics analysis, SLS is used to monitor the onset of aggregation by measuring scattered light intensity, which increases as protein aggregates form.

What It Measures:

  • Intensity of scattered light from aggregates
  • Molecular weight distribution of proteins and aggregates

Turbidimetry and Nephelometry

Turbidimetry measures the decrease in transmitted light due to scattering by aggregates, while nephelometry measures the intensity of light scattered at a specific angle. These techniques are highly sensitive for detecting the formation of aggregates, particularly in the early stages of aggregation when particles are small and colloidal in nature.

What It Measures:

  • The turbidity of the solution (light scattering) at different time points
  • The size of aggregates based on the amount of light scattered

Fluorescence Spectroscopy

Fluorescence spectroscopy utilizes intrinsic or extrinsic fluorescent markers to detect changes in the environment of the protein molecules, such as the formation of hydrophobic regions or the unfolding of proteins during aggregation. Extrinsic probes like bis-ANS or pyrene are used to report on aggregation, while intrinsic fluorescence (e.g., tryptophan emission) is used to assess conformational changes during aggregation.

What It Measures:

  • Emission spectra of fluorescence probes at various stages of aggregation
  • Changes in fluorescence intensity, wavelength shifts, and lifetimes

Microscopic Imaging (TEM, SEM, AFM)

Microscopic techniques such as Transmission Electron Microscopy (TEM), Scanning Electron Microscopy (SEM), and Atomic Force Microscopy (AFM) provide high-resolution images of the morphology and size of protein aggregates. These imaging methods allow for direct observation of aggregate structure and distribution in a biological formulation.

What It Measures:

  • Size, shape, and distribution of aggregates
  • Surface structure and morphology of aggregates (e.g., fibers, gels, and clusters)

Quartz Crystal Microbalance (QCM)

QCM is a surface-sensitive technique that measures the frequency change in a quartz crystal sensor as proteins interact with the surface. During aggregation kinetics analysis, QCM can be used to monitor the real-time formation of protein aggregates on sensor surfaces, providing insights into the kinetics of aggregation at interfaces.

What It Measures:

  • Mass changes at the sensor surface as protein aggregates form and adsorb
  • Time-dependent changes in the frequency of the quartz crystal oscillation

Regulatory Compliance and Quality Assurance

Our aggregation kinetics analysis services adhere to stringent industry standards and regulatory guidelines, ensuring high-quality, reproducible results for regulatory submissions and quality control. We comply with ICH Q6B, USP, and EMA guidelines for biopharmaceutical characterization, supporting clients in meeting global regulatory requirements.

Cooperate With Us

With extensive experience in protein aggregation behavior and biopharmaceutical characterization, STEMart employs state-of-the-art methodologies to investigate aggregation mechanisms and kinetics. Our expert team provides tailored solutions to meet the specific needs of the pharmaceutical industry, ensuring comprehensive data for formulation scientists and regulatory submissions.

For more information on our Aggregation Kinetics Analysis services or to discuss your specific biopharmaceutical project requirements, please contact us today.

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