Biomolecular stability analysis for the regulated environment - MicroCal PEAQ-DSC - 12 Pages

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Biomolecular stability analysis for the regulated environment - MicroCal PEAQ-DSC

Catalog excerpts

MICROCAL PEAQ-DSC Biomolecular stability analysis for the regulated environment

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INTRODUCTION TO DIFFERENTIAL SCANNING CALORIMETRY (DSC) WHAT IS DSC? Differential Scanning Calorimetry (DSC) is a powerful analytical technique which characterizes the thermal stability of proteins and other biomolecules. In solution, these molecules often undergo thermally-induced conformational changes, such as the breaking of non-covalent bonds leading to the unfolding of a protein. These types of structural rearrangement are detectable by DSC as they require the absorption of energy in the form of heat. Even in dilute solutions of protein, the new MicroCal PEAQDSC systems detect such...

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DSC analysis allows rapid identification of conditions that deliver optimum stability. The streamlined workflow and automated data analysis provided by MicroCal DSC systems accelerate screening of typical formulations and purification conditions, quickly delivering reliable results with minimum hands-on time, and driving productivity in research and development. MicroCal DSC instruments are found in many laboratory settings including those in the biopharmaceutical & pharmaceutical industries, contract research and manufacturing organizations, government institutions and academia. A choice...

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MicroCal PEAQ-DSC The MicroCal PEAQ-DSC system provides highly sensitive, easy-to-use microcalorimetry that helps reduce the time and cost associated with stability testing and comparability analysis. This is a manual instrument with a cleaning device, which can be upgraded to the automated version upon request. This complete system requires no additional accessories, reagents or consumables. The integrated software and automated data analysis support the generation of non-subjective, highly reproducible thermal stability data and help deliver compliance with regulatory requirements,...

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MicroCal PEAQ-DSC Automated The MicroCal PEAQ-DSC Automated system delivers high throughput and sensitivity, with low sample consumption, in an integrated platform for increased productivity. All cell filling and cleaning functions are fully automated, for walk-away operation. 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: • Screens up to 50 samples per day with unattended operation • Automated cell...

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The all-new MicroCal PEAQ-DSC software is available with an optional 21 CFR Part 11 compliance module. This makes both MicroCal PEAQ-DSC systems perfect for QC-type work, including root cause analysis and in-process measurements. Malvern has a wealth of experience working in cGxP environments. We understand the need for easy-to-use analytical systems that enable robust method development and transfer, with the support of 21 CFR Part 11 and also Annex 11 compliance tools and full lifecycle documentation. PEAQ-Compliance enables the control of electronic records via an audit trail and the...

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A further requirement for analysis in a regulated environment is instrument Performance Qualification (PQ), which includes regular checks on the system to ensure that it is performing within defined acceptance criteria. PEAQ-Performance, part of the MicroCal PEAQ-DSC software, is a new feature specifically designed to simplify these performance checks. Even if 21 CFR Part 11 compliance is not required for your DSC data, it is useful to frequently perform DSC analysis of a protein with a well-characterized DSC thermogram as a validation of instrument performance. Regular validation increases...

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PEAQ-Smart provides new and improved control and data analysis for faster experimental design and implementation. Embedded videos are included to give a visual overview of DSC experimental design and also guide maintenance of the system - these help users of every level proceed with confidence. In addition, a new PEAQ-Smart report designer is included. An SOP-Builder is built-in, to guide and accelerate experimental setup and provide the capability to perform rescans and downscanning for reversible denaturation studies. PEAQ-Smart provides a wide range of options for choosing buffer-buffer...

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DSC has excellent utility as a biophysical and higher order structure (HOS) analysis technique to investigate the comparability of protein samples. This has obvious value when comparing a biosimilar to a reference protein, but it is also very useful in establishing the comparability of batches of the same protein. For example, when substantial changes are made to the manufacturing process, a comparability exercise must be conducted to evaluate the impact of the change(s) on the product's critical quality attributes. DSC is commonly used as a HOS biophysical assay to show that the proteins...

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'Sample dependent; 2Typical results for ribonuclease (RNase) in 50 mM KAc buffer at pH 5.5, at 60°C/h with high feedback; ^Rescans of a stable buffer; 4Using ribonuclease (RNase); 5Range may be extended down to -10°C upon request

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WHY CHOOSE MALVERN PANALYTICAL? We are global leaders in materials characterization, creating superior, customer-focused solutions and services which supply tangible economic impact through chemical, physical and structural analysis. Our aim is to help you develop better quality products and get them to market faster. Our solutions support excellence in research, and help maximize productivity and process efficiency. Malvern Panalytical is part of Spectris, the productivity-enhancing instrumentation and controls company. SERVICE & SUPPORT...

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