Differential Scanning Calorimetry

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Differential Scanning Calorimetry

Method Introduction

Differential scanning calorimetry (DSC) and Micro Differential Scanning Calorimetry (µDSC) are important and frequently used thermal analysis techniques to study the thermal properties of materials. The sample is exposed to a temperature ramp, and the difference in heat flow between the sample and a reference (e.g., formulation buffer) is measured as a function of temperature or time. µDSC operates on the same basic principle as DSC but is designed for higher sensitivity and smaller sample sizes. It can detect very small thermal events that standard DSC might miss.

Applications

DSC provides critical thermodynamic data for biopharmaceutical development, from early candidate screening to formulation and manufacturing therapeutic proteins, peptides, nucleic acids and lipid-based drugs.

  • DSC is an important and frequently used technique in lyophilization process development for determining the glass transition temperature of the maximally freeze-concentrated solute (Tg’). This value is important for optimizing primary drying conditions. DSC can also determine the glass transition temperature of the freeze-dried amorphous product (Tg) and is used to define storage conditions for the final drug product.

    DSC is a standard technique used during lyophilization, process and formulation development, frequently combined with freeze-drying microscopy (FDM).

  • µDSC is widely used to characterize therapeutic proteins’ thermal stability and conformational changes and other biopharmaceuticals. It measures the temperatures at which proteins unfold or denature, providing insights into their overall stability and folding integrity.

  • µDSC can detect and quantify the thermodynamics of interactions between proteins and small molecule ligands, such as drug candidates or inhibitors. This aids in understanding binding mechanisms and optimizing drug design.

  • µDSC studies biopharmaceutical formulations’ thermal behavior and phase transitions, helping identify potential incompatibilities between the drug and excipients that could impact stability.

  • Regulatory agencies require demonstrating analytical comparability when making manufacturing changes to biopharmaceuticals. µDSC is a key technique for comparing thermal unfolding profiles to ensure the higher-order structure is maintained.

  • For lipid-based formulations like liposomes, µDSC characterizes lipid phase behavior, drug-lipid interactions, and the release of drugs from lipid carriers, aiding formulation development.

Quality and Biosafety Level

We provide all our analytical services with the highest quality standards. Experienced scientists carry out each project, and a scientific reviewer comprehensively checks every report or data presentation.

We offer this technology with the following quality and biosafety levels:

R&D level

We offer this method under R&D. Our GRP system assures the highest-quality research standards.

Up to biosafety level 2

This method can be applied to nucleic acids, viruses, cells, viral vectors, including lentiviruses and more.

Analytical Method Development, Qualification and Validation

For common sample types, we can often apply standardized methods with little setup effort. However, when needed, our experienced analytical experts create or optimize custom methods tailored to your active pharmaceutical ingredient, product type and development phase.

Method Development

Our method development approach tailors sample preparation, method settings and data analysis to the needs of your project and sample.

We include representative samples and, where available, suitable reference standards and stressed/degraded materials, allowing our analytical scientists to design a highly suitable, stability-indicating, robust and repeatable method. Upon request, we will compile a detailed description of the method for your records.

Method Qualification

Method qualification is the initial assessment of an analytical procedure’s performance to show its suitability for its intended purpose.

During method qualification, our analytical scientists perform documented testing demonstrating that the analytical procedure meets criteria in several categories. Criteria may include factors such as repeatability, specificity and robustness. We compile a qualification plan and report, including all relevant data.

Method Validation

Under GMP conditions, method validation confirms that an analytical procedure’s performance suits its intended purpose. Depending on the method’s scope, a broad range of method characteristics, such as specificity, accuracy, precision, limit of detection/limit of quantification (LOD/LOQ), linearity and range, is considered.

During method validation, our analytical scientists perform documented testing demonstrating that the analytical procedure consistently produces a result that meets the predetermined acceptance criteria. We compile a validation plan and report that includes all relevant data.

Depending on the development phase, a fit-for-purpose validation approach can be offered, adjusting the validation required efforts in a phase-appropriate way to meet the method’s needs.

Method Verification

Compendial method verification confirms that a compendial method (e.g., from Ph. Eur. or USP) is suitable and reliable for its intended purpose under the specific conditions of the laboratory.

Unlike full method validation, compendial method verification is often considered a partial validation since the method has already undergone extensive testing and validation during its inclusion in the compendium. The extent of method verification depends on the type of method.

During method verification, our analytical scientists perform documented testing demonstrating that the developed analytical method performs adequately for the specific product or matrix being tested and within the specific laboratory where the method will be employed.

Talk to Our Experts or Request a Quote

Our expert team is ready to answer your questions and guide you to the services best suited to your program’s modality, stage and challenge. If your needs are well-defined, we’ll begin the quotation process.

Description

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