药物生产

过程分析技术

提高最终产物的质量,降低药物生产的风险

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 NMRFT-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.

现代化过程分析技术优化药物生产

美国食品和药物管理局(FDA)将过程分析技术(PAT)定义为通过测量影响关键质量属性(CQA)的关键过程参数(CPP)来设计、分析和控制制药和生物制药生产工艺的系统。

PAT倡议是为了促进将新技术引入制药业生产。如今,竞争激烈的工业环境要求药物生产在降低生产成本的同时,还要不断努力提高产品质量。PAT的目标是加强对这一制造过程的理解和控制,这与FDA目前的药品质量体系是一致的:不应该在产品中测试药物质量,它应该是内在的,或者是设计好的(QBD)。

在常规的生产中,PAT能够实现连续和实时的质量保证(QA),以确保一批又一批的产品质量和性能稳定。结构化的产品和工艺开发,使用实验设计和在线或联机工艺分析仪器来实时收集数据,可以为工艺开发、优化、扩大规模、技术转让和质控提供更多的洞察和见解。对过程的了解会在生产阶段继续,这时可能会遇到其他变量(如环境和供应商的变化)。因此,在产品的生命周期中不断学习并应用这些学习成果是很重要的。

PAT为制药业提供了一个革新其研发和生产业务的框架,以便为他们自己和病人产生价值。PAT给企业带来的优势包括以下几点:

  • 减少浪费,第一时间进行药物生产,提升生产资料利用率
  • 实时的质量保证和验证
  • 进一步向实时产品发布迈进
  • 通过精简生产程序,减少原材料、半成品和成品库存
  • 进一步提升对公众的药品供应能力

布鲁克为PAT提供了一系列分析解决方案:即核磁共振(NMR)、傅里叶变换近红外(FT-NIR)、拉曼光谱、XRD和XRF光谱仪等。用于PAT的NMR不受样品基质的影响,无需校准,并且可以快速、频繁地提供数据。近红外、傅立叶变换近红外和拉曼光谱提供了基于振动光谱学的全面PAT解决方案。XRD特别适用于检测和预测可能发生并对药物质量产生不利影响的形态变化。XRF可以对元素杂质进行快速准确的量化,提供即时反馈。

LabScape

布鲁克BioSpin 核磁共振和临床前成像产品的服务和生命周期支持

布鲁克承诺在整个购买周期内为客户提供无与伦比的帮助,从最初的咨询到评估、安装,以及仪器的使用寿命,这是LabScape 始终坚持的服务理念。

LabScape 的维护协议(Maintenance Agreements)、现场自选服务(On-site On-Demand)和实验室改进计划(Enhance Your Lab)旨在为现代实验室提供一种新的维护和服务方法。

LabScape-Remote Monitoring