药物生产

过程分析技术(PAT)

提高成品质量,降低药物生产风险

Optimize your manufacturing by implementing modern Process Analytical Technology

Process analytical technology (PAT) is defined by the United States Food and Drug Administration (FDA) as a system for designing, analyzing, and controlling pharmaceutical and biopharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP), which affect Critical Quality Attributes (CQA).

PAT initiative is an effort to facilitate the introduction of new technologies into manufacturing in the pharmaceutical industry. Today's competitive industrial environment requires drug manufacturing that continuously strives to improve product quality while reducing production costs. The goal of PAT is to enhance understanding and control this manufacturing process, which is consistent with the FDA's current drug quality system: quality cannot be tested into products; it should be built-in or should be by design (QBD).

In routine manufacturing, PAT enables continuous and real-time quality assurance (QA) to ensure consistently high product quality and performance, batch after batch. Structured product and process development, using experimental design and on or in-line process analyzers to collect data in real-time, can provide increased insight and understanding for process development, optimization, scale-up, technology transfer, and control. Process understanding then continues in the production phase when other variables (e.g., environmental and supplier changes) may possibly be encountered. Therefore, continuous learning over the life cycle of a product and applying those learnings is important.

PAT offers the pharmaceutical industry a framework for revolutionizing its R&D and manufacturing businesses, to produce value for both themselves and patients. The main benefits associated with PAT for companies include:

  • Reduced waste, right-first-time manufacturing, higher production asset utilization
  • Real-time quality assurance and validation
  • Increased movement toward a real-time product release
  • Reduced raw material, work-in-progress, and finished goods inventories by lean manufacturing processes
  • Increased robust product supply to the public·

Bruker offers a range of tools for PAT: namely NMR, FT-NIRRaman spectroscopy, XRD, and XRF spectrometry. NMR for PAT is independent of the sample matrix, needs no calibration, and can deliver data quickly and frequently. NIR, FT-NIR, and Raman provide a comprehensive range of PAT solutions based on vibrational spectroscopy. XRD is particularly suited to detect and anticipate form changes that may occur and adversely affect drug substance quality. XRF allows for rapid and accurate quantification of elemental impurities, providing immediate feedback.

Free eBook:

‘QdB & PAT for Dummies’ offers a simple and easy to follow guide on what Quality by Design (QdB) and PAT are, the regulatory framework supporting these approaches, as well as how leveraging these concepts can positively transform production processes and quality testing.

通过现代过程分析技术(PAT),优化药物生产

据美国食品药物监督管理局(FDA)的定义,过程分析技术(PAT)被认为是这样一套体系——它可测定关键工艺参数(CPP)(该参数可影响关键质量属性(CQA)), 进而对制药以及生物制药的生产工艺进行设计、分析和控制。

为了促使制药行业将新型技术引入到生产中,PAT技术油然而生。日趋激烈的行业竞争使得药物生产需要在降低成本的同时,不断提高产品质量。PAT的目标是深入研究并控制生产工艺。这一目标与FDA目前的药品质量监管体系是一致的,即药物质量应源于设计 (QBD),而非源于检测 (QBT)。

在常规生产中,PAT能够持续地对产品进行实时监控,实现质量保证(QA),并确保不同批次间的产品质量能保持一致。结构产品和工艺开发需通过实验室设计以及在线/近线工艺分析仪进行实时数据收集——这不仅有助于深化对工艺开发、优化、放大、技术转化和控制的理解, 还能即时反馈其它变量(如环境变化,供应商更替)对生产造成的影响。因此,在产品的生命周期中不断学习并学以致用,这对制药行业而言至关重要。

PAT为制药行业的研发和生产提供了一个夯实的框架,有助于其发展革新。这无论是对于厂商还是患者而言,都大有裨益。PAT为制药厂商带来的主要好处为:

降低废料数量,实现“一次准确”式生产,并提高生产原料利用率,

实现实时质量保证与验证

进一步走向“实时产品放行”

通过精简生产工艺,可减少原材料、在制品以及成品库存

提高产品供应能力及可靠性

布鲁克为PAT体系提供一系列测试仪器,即核磁共振(NMR)、傅里叶变换近红外光谱(FT-NIR)、拉曼光谱、X射线衍射(XRD)和X射线荧光(XRF)光谱仪。用于PAT的NMR不受样品基质的影响,无需校准,测试速度快且周期短。近红外、傅立叶变换近红外和拉曼光谱则为PAT解决方案提供了全面的振动光谱测量。而X射线衍射特别适用于检测并预测可能对药物质量产生不利影响的结构变化。X射线荧光则可快速准确地量化杂质元素,提供即时反馈。

支持

服务和生命周期支持

布鲁克致力于在整个购买周期内为用户提供出色的帮助,从最初的咨询到评估、安装以及仪器的全使用周期,现在均包含在LabScape服务理念当中。

LabScape维保协议、现场按需服务和实验室升级服务,旨在为现代实验室提供一种全新的维护和服务方式。