Malvern launches MicroCal PEAQ-DSC for faster, more accurate characterization of protein and biomolecule stability

Top Quote The new MicroCal PEAQ-DSC microcalorimeter from Malvern Instruments resets the performance standard for characterizing protein and biomolecule stability. End Quote
  • (1888PressRelease) March 16, 2017 - Malvern, UK: This latest innovation in Differential Scanning Calorimetry (DSC) has been created specifically for the regulated environment and delivers essential data to guide biopharmaceutical development, from protein engineering, through pre-formulation and process development, to formulation and manufacture of the final product.

    The new system offers developers a quick stability assay to identify biotherapeutics with good stability potential and enables them to determine the conditions that maximize the shelf-life of a biotherapeutic. In manufacturing, it helps maximize yields of biotherapeutic compounds and supports the robust demonstration of batch-to-batch comparability or innovator to biosimilar comparability.

    MicroCal PEAQ-DSC delivers unattended 24-hour operation, together with streamlined workflows and automated data analysis to produce results in hours, driving productivity and efficiency gains in research and production. In addition, the system is network-ready, and has built-in automated cleaning and self-validation protocols that minimize downtime and ensure that all data reported is of the highest quality. Dedicated instrument standards are available so that performance can be validated throughout a series of runs.

    Importantly, MicroCal PEAQ-DSC is available with full documentation and software support for Analytical Equipment Qualification, in line with USP and FDA guidance, as well as a comprehensive package to aid technical compliance to FDA CFR Part 11 and EU GMP Annex 11.

    Ronan O'Brien, Head of Business Development - MicroCal at Malvern, said: "We are very excited to be putting such a capable tool in the hands of our customers. We have worked closely with users of our previous-generation DSC system to make sure that the MicroCal PEAQ-DSC supports a wide range of needs across the biopharma development cycle. As the importance of biopharmaceuticals continues to grow, we see customers searching for powerful analytical systems that can deliver data that genuinely informs development, formulation and process decisions, as well as supporting regulatory challenges. DSC has long been considered the gold standard for stability measurement but now, with the new MicroCal PEAQ-DSC, we believe we have redefined what is possible with this technique."

    MicroCal PEAQ-DSC is available in two versions: a standalone instrument that includes the DSC cell and a dedicated computer, or a fully automated system with the addition of a liquid handling robot. Either can be specified with the 21 CFR Part 11 software package.

    For more information about MicroCal PEAQ-DSC, please visit: www.malvern.com/MicroCalDSC
    Malvern, Malvern Instruments are registered trademarks of Malvern Instruments Ltd
    MicroCal is a trademark of Malvern Instruments Ltd

    High resolution image attached or available from Kapler Communications malvern ( @ ) kapleronline dot com

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    About Malvern Instruments
    Malvern provides the materials and biophysical characterization technology and expertise that enable scientists and engineers to understand and control the properties of dispersed systems. These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries. Used at all stages of research, development and manufacturing, Malvern's materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency.

    Our products reflect Malvern's drive to exploit the latest technological innovations and our commitment to maximizing the potential of established techniques. They are used by both industry and academia, in sectors ranging from pharmaceuticals and biopharmaceuticals to bulk chemicals, cement, plastics and polymers, energy and the environment.

    Malvern systems are used to measure particle size, particle shape, zeta potential, protein charge, molecular weight, mass, size and conformation, nanoparticle size and count, rheological properties and for chemical identification, advancing the understanding of dispersed systems across many different industries and applications.

    Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, Mexico, China, Japan and Korea, a joint venture in India, a global distributor network and applications laboratories around the world.
    www.malvern.com

    For press information, please contact:
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    1 Whiteside, Station Road, Holmes Chapel, CW4 8AA, UK
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    malvern ( @ ) kapleronline dot com

    Please send sales enquiries to: Alison Vines, Malvern Instruments Ltd
    Enigma Business Park, Grovewood Road, Malvern, Worcestershire, WR14 1XZ, UK
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