SBIR Phase I: PAT Software Platform for Process Analytical Technology Implementation

该小型企业创新研究I期研究项目旨在针对FDA过程分析技术（PAT）计划的需求建立新型软件平台的“概念验证”，该计划是创新药物开发，制造和质量保证的框架。PAT在三个层面上实施：过程理解;质量设计;以及监控，预测和控制。PAT的实施受到缺乏可重用和可扩展的PAT软件平台的阻碍，该平台可用于构建PAT分析工具，这些工具可与越来越多的商业分析仪集成和互操作。第I阶段计划旨在通过应用于PAT 1级工作流程（旨在开发过程理解），对PAT软件平台进行“概念验证”。该项目将使用原型PAT软件开发工具包（PSDK）来组装应用程序，以自动执行PAT 1级工作流程。将通过证明平台的准确性、识别、预测、性能和能力来确定可行性。第二阶段将扩大研究范围，以满足PAT 2级和3级的要求。最终目标是提供一个商业PAT软件开发工具包，允许客户组装自己的PAT应用程序，供研究、开发和工厂工人使用，以提高生产质量。拟议的PAT软件平台直接支持FDA的过程分析技术（PAT）计划，该计划是FDA 21世纪世纪cGMP的一部分，旨在帮助全球制药界达到由以下内容组成的“理想状态”：（1）通过设计有效和高效的制造工艺来实现和保证产品质量和性能;（2）产品规格是基于对配方和工艺因素如何影响产品性能的机械理解;以及（3）制造商能够实现持续改进和持续“实时”质量保证。PAT软件平台允许组装集成和可互操作的PAT软件应用程序，这些应用程序（a）为分析、监控、控制和预测（建模）提供通用环境，（B）促进软件、分析仪和存储系统之间的PAT数据交换，以及（c）提供单一环境，在该环境中挖掘和分析数据以提取过程知识。PAT软件平台将帮助制药公司降低验证和培训成本，最大限度地缩短部署时间，并提高PAT系统的可靠性。一个通用的PAT软件平台还将通过减少对定制接口代码的需求来帮助加速PAT被制药行业接受，定制接口代码的生产和维护成本高昂且耗时。

This Small Business Innovation Research Phase I research project aims to establish "proof-of-concept" of a novel Software Platform directed at needs of FDA's Process Analytical Technologies (PAT) initiative, a framework for innovative pharmaceutical development, manufacturing and quality assurance. PAT is implemented at three levels: Process Understanding; Quality by Design; and Monitor, Predict and Control. PAT implementation is hampered by the lack of a reusable and extensible PAT Software Platform, which can be used to construct PAT analysis tools that integrate and interoperate with an increasing number of commercial analyzers. The Phase I program is directed at "proof-of-concept" for the PAT Software Platform through application to PAT Level 1 workflow directed at developing process understanding. The project will use a prototype PAT Software Development Kit (PSDK) to assemble an application for automated execution of PAT Level 1 workflow. Feasibility will be established by demonstrating the accuracy, identification, prediction, performance, and capability of the platform. Phase II will extend the research to address requirements for PAT Levels 2 and 3. The ultimate aim is to provide a commercial PAT Software Development Kit that allows customers to assemble their own PAT applications for use by research, development and plant workers to improve manufacturing quality.The proposed PAT Software Platform directly supports FDA's Process Analytical Technology (PAT) initiative, part of the Agency's 21st Century cGMPs, directed at helping the global pharmaceutical community reach the "desired state" consisting of the following: (1) product quality and performance are achieved and assured by design of effective and efficient manufacturing processes; (2) product specifications are based on mechanistic understanding of how formulation and process factors impact product performance; and (3) manufacturers are able to effect continuous improvement and continuous "real-time" assurance of quality. The PAT Software Platform allows assembly of integrated and interoperable PAT software applications that (a) provide a common environment for analysis, monitoring, control and prediction (modeling), (b) facilitate the interchange of PAT data among software, analyzers and storage systems, and (c) provide a single environment in which to mine and analyze the data to extract process knowledge. The PAT Software Platform will help pharmaceutical companies reduce validation and training costs, minimize deployment time and improve the reliability of PAT systems. A common PAT Software Platform would also help accelerate PAT's acceptance by the pharmaceutical industry by reducing the need for custom interface code, which is costly and time consuming to produce and maintain.