马尔文发布MicroCal PEAQ-DSC微量热仪：重新定义蛋白质和生物分子稳定性表征的性能标准

2017年2月底，马尔文仪器发布新型微量热差式扫描量热仪MicroCal PEAQ-DSC，重新定义了蛋白质和生物分子稳定性表征的性能标准。MicroCal PEAQ-DSC专为对检测环境要求苛刻的生物制药行业而设计，可为从蛋白质工程的预配制、工艺开发到最终产品的配方和制造提供必要的数据指导。

该产品配置的新系统为开发人员提供了一种快速稳定的测定方法，该方法可以识别具有良好潜在稳定性的治疗药物，从而在确定的条件下，最大限度的延长治疗药物的保质期。另外在生产制造过程中，该系统有助于最大限度提高产量，并为批量生产批次间的比对及生物仿制药可比性的革新提供强大支持。

MicroCal PEAQ-DSC可在无人值守情况下24小时自动操作，提供简化的工作流程和自动化数据分析，在数小时内便产生结果，大大提高生产率和提高研发生产效率。此外，该系统是可以联网的，并具有内置的自动清洗和自我验证协议，可最大限度地减少停机时间，这就保证了高质量报告数据。

马尔文仪器MicroCal业务主管Ronan O"Brien表示：“我们非常高兴能够将这样一个优秀的产品投入到我们客户手中。为确保MicroCal PEAQ-DSC在生物制药开发周期中能够满足广泛的需求，我们始终与上一代DSC系统的用户保持密切合作。随着生物制药的重要性不断增长，我们看到客户对这样的产品更加感兴趣：可以提供真实发展的数据、制定和过程决策、支撑监管等强大分析系统。DSC一直被认为是稳定性测量的黄金标准，但是现在，随着马尔文MicroCal PEAQ-DSC的上市，相信我们已经重新定义了这种技术的无限可能性。”

February 21 2017  -Ref No: PR3217

The new MicroCal PEAQ-DSC microcalorimeter from Malvern Instruments resets the performance standard for characterizing protein and biomolecule stability. 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.