Protein Aggregation Onset Temperature (Tagg) Analysis

Protein aggregation is a critical concern in biopharmaceutical development, as it can lead to loss of efficacy, increased immunogenicity, and compromised safety. Understanding the aggregation onset temperature (Tagg) is crucial for predicting the stability of biologics and mitigating potential risks during development and manufacturing. Our protein Tagg analysis service offers precise and high-resolution detection of the temperature at which protein aggregation initiates under thermal stress. By integrating advanced analytical techniques, we provide critical insights that support formulation optimization, stability assessment, and quality control of therapeutic proteins, monoclonal antibodies (mAbs), fusion proteins, and other biologics.

Aggregation Onset Temperature (Tagg)

The Tagg refers to the temperature at which proteins begin to form aggregates due to thermal stress. This temperature is a key indicator of a protein’s colloidal stability and plays a vital role in predicting its behavior under storage and physiological conditions. Unlike the melting temperature (Tm), which signifies protein unfolding, Tagg reflects intermolecular interactions that drive aggregation. A lower Tagg suggests a higher tendency for aggregation, making it essential for evaluating formulation strategies and optimizing storage conditions.

Our Advanced Tagg Detection Methods

Dynamic Light Scattering (DLS)

DLS measures fluctuations in the intensity of scattered light due to Brownian motion of particles in solution. As proteins begin to aggregate, their hydrodynamic radius increases, altering light scattering patterns.

Real-time monitoring, high sensitivity to small particle size changes.
Rapid screening of formulation stability, buffer optimization.

Turbidity Measurement (OD350)

As protein aggregates form, they increase the turbidity of the solution, which can be quantified by measuring optical density at 350 nm (OD350). Higher OD350 values indicate increased aggregation.

Simple, high-throughput, cost-effective.
Comparing formulation aggregation tendencies, assessing stress-induced aggregation.

Static Light Scattering (SLS)

SLS measures the intensity of scattered light at multiple angles, allowing for the quantification of aggregate formation and molecular weight distribution.

Provides aggregation kinetics, molecular interaction insights.
Stability studies, characterization of aggregation profiles.

Nanoparticle Tracking Analysis (NTA)

NTA tracks the movement of individual particles in solution and calculates their size based on Brownian motion. Providing real-time particle size distribution and concentration data by monitoring the emergence of aggregates as temperature increases,

Precise aggregate size and concentration measurement.
Sub-visible particle detection, regulatory compliance assessment.

Service Applications

Our Tagg analysis supports a wide range of biopharmaceutical products, including:

Monoclonal Antibodies (mAbs) - Ensuring thermal stability and aggregation control.
Recombinant Proteins - Identifying optimal storage and formulation conditions.
Fusion Proteins & Enzymes - Evaluating long-term stability for therapeutic applications.
Viral Vectors & Nanoparticle-Based Therapies - Ensuring structural integrity during manufacturing and storage.

Deliverables & Reporting

Clients receive a comprehensive analytical report, including:

Tagg values determined using multiple techniques.
Graphical data representation (temperature vs. aggregation profiles).
Interpretation of results with formulation recommendations.
Customizable study designs based on client requirements.

For more information on our Protein Tagg Analysis service or to discuss your specific biopharmaceutical project requirements, please contact us today.