Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi 110016, India.
Anal Bioanal Chem. 2010 Sep;398(1):137-54. doi: 10.1007/s00216-010-3781-x. Epub 2010 May 18.
The "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk Based Approach" initiative announced by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing facilitated adoption of process analytical technology (PAT) by the pharmaceutical industry. The potential for improved operational control and compliance resulting from continuous real-time quality assurance was highlighted as a likely benefit that would result from PAT implementation. A considerable amount of work has been done on this topic by academic and industrial contributors in the last decade. In this paper, we will start with a brief overview of evolution of PAT concepts and a review of their application in the wider pharmaceutical industry. The rest of the paper focuses on PAT applications for biotech processes with emphasis on developments in the last five years. It is our observation that while significant advances have been accomplished with regard to our ability to analyze/monitor key process and quality attributes in the biotech industry, much more needs to be done with regard to utilizing the collected data for subsequent control of the process, to achieve optimum yield and product quality. The latter is necessary to achieve the benefits that will result from PAT implementation.
美国食品药品监督管理局（FDA）于 2002 年 8 月宣布了“21 世纪制药现行良好生产规范（CGMP）——基于风险的方法”倡议，以改进和现代化制药生产，促进制药行业采用过程分析技术（PAT）。从 PAT 实施中可能获得的潜在改进运营控制和合规性的优势，强调了连续实时质量保证的潜在好处。在过去的十年中，学术界和工业界的贡献者在这个主题上做了大量的工作。在本文中，我们将首先简要概述 PAT 概念的演变，并回顾它们在更广泛的制药行业中的应用。本文的其余部分重点介绍 PAT 在生物技术工艺中的应用，重点介绍过去五年的发展。我们观察到，尽管在生物技术行业中我们已经在分析/监测关键工艺和质量属性的能力方面取得了重大进展，但在利用收集的数据来后续控制工艺以实现最佳收率和产品质量方面，还有很多工作要做。后者是实现 PAT 实施所带来的好处的必要条件。
