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Differential Scanning Calorimetry (µ-DSC) Services for Biosimilarity Studies

Related topics:

μ-DSC is considered the gold standard analytical method for thermal stability analysis of biomolecules in protein engineering and in biopharmaceutical formulation development. Thermograms provide quantitative information on domain structures and interactions, as well as individual transition temperatures for all observed transition events.

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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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General topics:

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

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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.

Microcal Differential Scanning Calorimetry (μ-DSC) for Biosimilarity Studies

In comparison to conventional drugs, biopharmaceuticals are significantly larger and structurally more complex molecules. Their importance in the pharmaceutical market has grown immensely, and thus reliable methods of characterization are essential in order to gain regulatory approval for these products.

This does not solely apply to the development of new products. Biosimilars must be tested thoroughly against the innovator for similarity, including their thermal stability, a feature that is assessable via µ-DSC. Thermal stability is as unique as a fingerprint and is therefore very useful to identify a molecule or compare to another.

μ-DSC knows few restrictions concerning the formulations in which a molecule is tested and does not rely on molecule modifications, such as introduction of markers. With a high reproducibility it is applicable to batch-to-batch measurements and provides reliable high-quality data.

biological complexity
Selected conventional drugs (paracetamol and amoxicillin) and biologicals with increasing structural complexity and size are compared

Please follow the link to learn further about DSC theory.

Zentriforce Pharma Quality System

We know that μ-DSC measurements are relevant for your regulatory submissions. ZentriForce Pharma has established a laboratory quality system that closely follows guidelines provided by the WHO and the principle of “writing what you do and doing what you write”.

ZentriForce implements procedural, equipment and analytical SOPs. These ensure that equipment is correctly operated and meticulously maintained by qualified personnel only, that customer samples are handled by trained laboratory operators with utmost care and precision, and that confidentiality has highest priority in all aspects of our relationship with our customers. We are also more than open to audits of and the results we collected for you.

Please follow the link to a detailed description of our quality system.

μ-DSC Specific Services

Our scientists have worked with a wide range of biopharmaceutical products. Our experience keeps your expenses low. The automated MicroCal PEAQ-DSC 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 learn more. If your sample type is not mentioned there, feel free to contact us directly.

Intersted in Analytical Services ?

We are more than happy to assist you with your biosimilarity study.

μ-DSC Specifications

Main OutputTm (Transition midpoint); ∆Cp (Heat capacity change); ∆H (Enthalpy)
Typical sample concentration0.01 to 10 mg/mL
Aditional Outputsbinding constants up to 1020M-1, Tonset
Sample Volume325 µl (minimum in well)
Measurement typewell plate (96 wells)
Temperature range2°C – 130 °C
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