Below are the forthcoming shows that will exhibit Malvern’s pharmaceutical solutions. Conferences and Exhibitions 29...
MicroCal PEAQ-DSC Automated is a high-quality protein stability analysis instrument, designed for the regulated environment. This system delivers high-throughput, sensitive protein stability analysis, with low-sample consumption, in an automated, integrated platform for increased productivity.
All featured cell-filling and cleaning functions are fully automated and data generated provides critical guidance for biopharmaceutical development in protein engineering, pre-formulation and process development, manufacturing change control, and biosimilarity studies.
This machine can operate unattended for 24 hours, with the integrated software streamlining workflow and facilitating non-subjective data analysis. The system performs in 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 (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.
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 characterize and evaluate protein constructs, and to rank the affinities of ligands to their protein targets in small molecule drug discovery programmes.
The high-throughput, high-sensitivity MicroCal PEAQ-DSC Automated system features software that streamlines workflows through simplified experimental setup and flexible instrument scheduling. Automated data analysis supports the generation of high integrity thermal stability data and delivers compliance with regulatory requirements, whilst allowing easy integration into existing data handling and transfer systems.
Key Features of the device include:
- Stability-indicating technique requiring minimal assay development
- Direct and label-free measurement of biomolecular native-state stability in solution
- Standard 96-well plate format for high capacity and easy loading, with thermostatically-controlled storage of up to 6 plates
- Fully integrated autosampler enables unattended analysis of up to 50 samples per day
- Automated cell filling and cell cleaning functions permit unattended operation
- Measurement of very tight binding constants, up to 10M
Powerful MicroCal PEAQ-DSC software minimises typical data analysis time and includes:
- PEAQ-Compliance, available with Malvern access controller (MAC) to limit access to user-defined standard operation 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 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
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