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Zentriforce Pharma Research GmbH 2024 – all rights reserved
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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μ-DSC provides a direct and label-free thermodynamic characterization of biomolecules in solution. Popular applications are stability studies during formulation development and biosimilarity studies, due to the “structural fingerprint” character of thermograms.
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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.
ZentriForce Pharma is always looking for motivated and dedicated employees. Check out our career page for further information.
The development of biopharmaceuticals poses many challenges, one of which is to ascertain stability, for example during formulation development and production optimization. μ-DSC investigates the influence of critical factors on sample stability, such as pH, ionic strength, and excipients.
Furthermore, characterization of the higher order structure of new biopharmaceuticals is essential to a successful regulatory submission. µ-DSC thermograms provide quantitative information on domain structures, as well as melting, unfolding or aggregation temperatures.
μ-DSC can easily access conformational changes and phase transitions. Some classic applications are for proteins and lipid/liposome-based drug delivery systems.
Please follow the link for a more detailed description of dynamic scanning calorimetry theory.
ZentriForce Pharma laboratories are equipped with a Malvern MicroCal Automated PEAQ-DSC, located in a Biosafety Level 2 (S2) laboratory. The instrument design is ideal for analysis of liquid samples in a regulated biopharmaceutical environment.
Multiple heating and cooling cycles may be performed with minimum sample consumption in the temperature range of 2°C – 130 °C. In addition, an autosampler provides hands-free operation.
Samples are loaded in a standard microplate format (96-well plate) and stored in temperature-controlled cooling stacks. The minimum sample volume required is 325 µL per well.
Moreover, the instrument conducts automatic cleaning protocols between each sample measurement to prevent sample carryover.
Our scientists worked with a wide range of biopharmaceutical products. Our experience keeps your expenses low. We work with cutting edge instrumentation that offers high sensitivity, precision and reproducibility at low sample consumption.
The MicroCal PEAQ-DSC Automated system offers valuable stability data for biotherapeutics in discovery, development and manufacturing.
| 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 |
Zentriforce Pharma Research GmbH 2024 – all rights reserved