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Reliable Solutions for Next-Gen Biotherapeutic Development

TA Instruments | Waters Corporation offers a suite of reliable solutions that are essential for ensuring desired product quality and guaranteeing safety and efficacy in the biopharmaceutical industry. Our Microcalorimetry, Thermal Analysis and Rheology solutions correspond to critical quality attributes (CQAs) that must be carefully measured for all kinds of biotherapeutics, including antibodies, cell and gene therapies, and vaccines. Biotherapeutics, unlike chemically synthesized drugs, can be heterogenous in nature and therefore require rigorous quality testing during development and manufacturing.

Characterization of biopharmaceuticals is accomplished with a panel of technologies to understand their basic chemical details:

  • Binding affinity, specificity, and stoichiometry (ratio) to the molecular target
  • Structure stability, and solvent environment stability.
  • Higher Order Structure (HOS)
  • Phase transitions
  • Viscosity and viscoelastic behavior
  • Residual moisture

Explore solutions from TA Instruments | Waters Corporation for biotherapeutics at different development stages. Click on each stage to learn how we can support your next-gen biotherapeutics.

Analytical Solutions for Biotherapeutic Characterization

Understanding cellular pathways is important for addressing key questions in life sciences and combating diseases. Target selection involves identifying a biological target (usually a protein or receptor) that plays a key role in a disease process. Choosing the right target is fundamental because it determines the success of subsequent drug development efforts. The correct target ensures that drugs act specifically on disease-related pathways and off-target effects can be minimized, enhancing drug efficacy and avoiding adverse effects. For instance, a drug targeting a cancer-specific protein is less likely to harm healthy tissues, improving patient safety and overall tolerability. A well-selected target increases the likelihood of therapeutic utility. 

Isothermal Titration Calorimetry (ITC) is a powerful technique used to study molecular interactions by measuring the heat exchanged during binding events. By quantifying heat, ITC provides insights into the driving forces behind interactions. Understanding the type and strength of interaction—whether it’s hydrophobic, electrostatic, or other types of interactions—is key. This knowledge enables researchers to design appropriate drugs achieving the desired therapeutic effects by targeting specific points within cellular pathways. 

Differential Scanning Calorimetry (DSC) measures the heat absorbed or released during thermal transitions, such as protein unfolding and complements ITC by focusing on the stability and structural characteristics of molecules. Knowing the stability of target molecules is essential for drug development. DSC allows scientists to design better therapeutics and understand differences between native and diseased states. Researchers gain a comprehensive view of molecular interactions by combining ITC and DSC data. 

Affinity ITC

  • Binding Affinity
  • Thermodynamic Driving Forces
  •  Stoichiometry

Affinity Range: low-mM, to low-pM
Automation: 96-well plate compatible

Nano DSC

  • Protein Stability
  • Complex Characterization – Binding
  • Nucleic Acid Melting
  • Phase Transitions
  • Heat Capacity

Temperature Range: -10 °C to 130 °C
Automation: 96-well plate compatible

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