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μ-DSC is highly effective to demonstrate biosimilarity, which is done by the direct comparison between the thermogram (a structural “fingerprint”) of the reference product and a biosimilar candidate. In addition, it provides high data reproducibility and sensitivity to factors influencing thermal stability and conformational changes.
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Temperature stability is a critical parameter in drug product development, especially during formulation development or within biosimilarity studies. μ-DSC is the gold standard analytical method for thermal stability analysis of biomolecules. Additionally, ZentriForce Pharma offers static and dynamic light scattering (SLS and DLS) methods that, when applied during a temperature ramp, are fast formulation screening tools for thermal stability characterization.
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ZentriForce Pharma was founded as a service provider specialized in hydrodynamic techniques used for biopharmaceutical development. The focus lies on gene therapy products and biosimilarity studies. For further information follow the link to our company page
ZentriForce Pharma implemented a strict quality system to assure the highest tractability of results generated at our facility. We have a wide range of quality related standard operation procedures (SOPS) in place to assure the consistency and quality of our laboratory operations. Please follow the link to a description of our quality system.
ZentriForce Pharma is your expert in analytical services, with focus on hydrodynamic techniques. Please follow the link to find out about our analytical services.
ZentriForce Pharma offers a wide range of analytical techniques. Please follow the link to our analytical portfolio.
ZentriForce Pharma’ strength is not restricted to expertise in analytical services. Our scientist are also actively involved in the further advances in the theory of hydrodynamic techniques. Please follow the link to a detailed description of the theory behind our analytical services, including some of our own research.
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MicroCal Differential Scanning Calorimetry (μ-DSC) is a highly sensitive technique applied to study thermally induced transitions, such as phase changes and folding/unfolding of proteins. It is considered the gold standard for thermal stability analysis of biomolecules in protein engineering and in biopharmaceutical formulation development. Various advantages of μ-DSC include a high reproducibility, few restrictions concerning formulations / solvents and no need for markers or tryptophan in the analyte. It provides a direct and label-free measurement of biomolecular stability in solution.
During the heating of a biomolecule or mixture, several thermal events may occur simultaneously or sequentially, indicating the unfolding or melting temperatures of different domains of the same molecule. The µ-DSC thermograms register the respective midpoints (Tm) by measuring the heat capacity change as a function of temperature. The enthalpies can be derived from this plot. When considering a protein’s folding/unfolding process, the higher the temperature at which this event takes place, the more thermodynamically stable the molecule.
Conformational changes are easily accessible by μ-DSC thermograms. The variation in heat capacity as a protein unfolds is primarily due to the changes in hydration of side chains – buried in the protein when in its native state – that become exposed to the solvent when unfolded. Proteins with high temperature midpoints are less likely to denaturation at lower temperatures, therefore, Tm is a good indicator of protein thermostability.
In addition to stability, binding and drug delivery systems integrate μ-DSC wide range of applications. Upon binding of ligands and drug uptake, intra and intermolecular interaction changes, as well as the dynamic of the components, and can be investigated by monitoring the phase transition temperatures and enthalpies from the thermograms.
ZentriForce Pharma laboratories are equipped with a Malvern MicroCal Automated PEAQ-DSC. The instrument is optimized for liquid samples and measures the temperature dependence of the heat capacity. Changes in heat capacity are associated with material transitions. The system is equipped with an autosampler for hands-free operation and samples are loaded in standard 96-well plate format (with minimum volume 325 µL in well).
Our scientists have worked with a wide range of biopharmaceutical products. Our experience keeps your expenses low. The MicroCal PEAQ-DSC Automated system offers valuable stability data for biotherapeutics in discovery, development and manufacturing. We work with cutting edge instrumentation that offers high sensitivity, precision and reproducibility at low sample consumption (minimum 325 µl).
We provide detailed information for specific sample categories. Please follow the links in the related topics section on the left to find sample specific Micro-DSC information.
If your sample type is not mentioned in the topics section, feel free to contact us directly.
|Main Output||Tm (Transition midpoint); ∆Cp (Heat capacity change); ∆H (Enthalpy)|
|Typical sample concentration||0.01 to 10 mg/mL|
|Aditional Outputs||binding constants up to 1020M-1, Tonset|
|Sample Volume||325 µl (minimum in well)|
|Measurement type||well plate (96 wells)|
|Temperature range||2°C – 130 °C|