MicroCal PEAQ-DSC Manual for Stability Testing

The MicroCal PEAQ-DSC system offers sensitive, simple microcalorimetry for time and cost-effective stability testing and comparability analysis.

The MicroCal PEAQ-DSC is a manual instrument with an integrated cleaning device, which can be upgraded to an automated version upon request. Data generated provides critical guidance for biopharmaceutical development in protein engineering, (pre)formulation development, process development, manufacturing change control, and biosimilarity studies.

The integrated software streamlines workflows, facilitating non-subjective data analysis and performing qualification. The system ensures compliance with 21 CFR Part 11 and Annex 11 regulations, delivering high-integrity data and driving productivity in biopharmaceutical research.

Differential scanning calorimetry (DSC) is a powerful analytical tool for characterising the thermal stability of proteins and other biomolecules. The technique measures the enthalpy (ΔH) and temperature (T) of thermally induced structural transitions of molecules in solution.

This information provides valuable insights into factors that stabilise or destabilise proteins, nucleic acids, micellar complexes, and other macromolecular systems. The data is used to predict shelf-life of biomolecular products, including biopharmaceuticals, to enable batch-to-batch and biosimilar versus innovator molecule comparisons, develop purification strategies, characterise and evaluate protein constructs, and to rank the affinities of ligands to their protein targets in small molecule drug discovery programmes.

Key Features:

• Stability-indicating technique requiring minimal assay development
• Direct and label-free measurement of biomolecular native-state stability in solution
• Measurement of very tight binding constants, up to 10M
• Manual system with pipette and cleaning device

Powerful MicroCal PEAQ-DSC software minimises typical data analysis time, these include:

• PEAQ-Compliance system, available with Malvern access controller (MAC) to limit access to user-defined standard operating practices (SOP) and data analysis features. Data can be displayed using the report generator, with user details and the ability to sign using electronic signatures to facilitate the integration of the workflow into your company’s quality system and aid compliance with 21 CFR Part 11 and Annex 11 regulations. This is provided as an optional accessory.
• PEAQ-Performance automatically detects and validates system readiness for optimal performance
• PEAQ-Smart (including PEAQ-Finder) for SOP-based operation and data analysis. It provides new algorithms to detect even subtle peaks and shoulders, facilitating the automatic, non-subjective identification of multiple transitions, such as those seen in multi-domain proteins.
• PEAQ-Compare for the quantitative comparison of DSC traces for comparability studies, ideal for batch-to-batch and biosimilarity studies
• Network-ready email updates sent during the analysis to keep you informed of assay progress