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Tm (melting temperature) and Tagg (aggregation temperature) are essential parameters for understanding the thermal stability and aggregation behaviour of biopharmaceutical proteins, especially monoclonal antibodies (mAbs). Monitoring and optimizing these values during product development and formulation can ensure that the protein maintains its functional integrity and does not form aggregates that could reduce efficacy or increase immunogenicity. Together, these parameters help:

  • Assess product stability and shelf-life.
  • Guide formulation strategies and storage conditions.
  • Ensure batch-to-batch consistency.
  • Monitor stress testing and stability studies.
For biosimilars, both Tm and Tagg are critical in demonstrating structural comparability to the reference product. Therefore, these values play a key role in ensuring the safety, efficacy, and regulatory compliance of therapeutic proteins.

Tm indicates the point where the protein unfolds, while Tagg identifies the temperature at which the protein begins to aggregate. A high Tm typically correlates with a higher Tagg, suggesting that a stable protein is less likely to aggregate under thermal stress.

Aragen can provide the high through-put and seamless support to determine the Tonset, Tm & Tagg (266nm & 473nm) by using the cutting-edge technology i.e. DSF & SLS

  • 266nm ment for smaller aggregation
  • 473nm is for higher aggregation

For more details consult our Experts

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