MicroCal PEAQ-DSC systems deliver highly sensitive, easy-to-use microcalorimetry that reduce the time and cost associated with stability testing and comparability analysis. The MicroCal PEAQ-DSC is a manual instrument with a cleaning device.
Data generated by the MicroCal PEAQ-DSC provides critical guidance for biopharmaceutical development in protein engineering, (pre)formulation development, process development, manufacturing change control and biosimilarity and biocomparability studies.
The integrated software streamlines workflows, facilitates non-subjective data analysis, performance qualification and compliance with 21 CFR Part 11 and Annex 11 regulations, all delivering high integrity data and driving productivity in biopharmaceutical research.
Overview
Differential Scanning Calorimetry (DSC) is a powerful analytical tool for characterizing the thermal stability of proteins and other biomolecules. The technique measures the enthalpy (ΔH) and temperature (Tm) 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, to develop purification strategies, to characterise and evaluate protein constructs, and to rank the affinities of ligands to their protein targets in small molecule drug discovery programs.
The high-sensitivity MicroCal PEAQ-DSC system features automated data analysis to support the generation of high integrity thermal stability data and deliver compliance with regulatory requirements, while allowing easy integration into existing data handling and transfer systems.
Unattended operation of the instrument after sample loading frees operator time. This complete system requires no additional accessories, reagents or consumables.
Key Features
- Gold standard 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 1020M-1
- Manual system with pipette and cleaning device
Powerful MicroCal PEAQ-DSC software minimizes typical data analysis time and includes:
- PEAQ-Compliance: The system is available with Malvern Access Controller (MAC) to limit access to user-defined SOPs 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. 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
For more information about this product, please contact Malvern via the enquiries form.
