Product lifecycle management (PLM) is a term that describes the ways in which manufacturers connect computer aided design (CAD) with engineering and manufacturing requirements in order to speed product development cycles, manage quality and cost, and track products through distribution and end of life. Rooted in the automotive and aerospace segments, it has been a technology category that has been unique to the discrete industries. But that’s changing as life sciences companies look to have better control over product lifecycles.
Specifically, the pharmaceutical industry is under pressure to accelerate drug design, shorten time-to-market and lower operational costs, all while abiding by increasing government regulations. In order to do all of this, everything must be connected—from process design to manufacturing execution to quality assurance and managing revisions. But many pharmaceutical companies have departments set up in silos while production is often outsourced, making it difficult to connect the digital dots.
认识到这个问题以及机会 - 包括西门子，达索系统和Oracle在内的许多PLM供应商正在为PLM提供工艺制造。而且，尽管这些提供商可能具有出色的文档管理和融合虚拟和物理模型的方式，但它们可能缺乏新移民的东西Neo PLMbrings to the table. And that is a completely different approach.
According to Cathal Strain, CEO of Neo PLM, the issue with existing PLM vendors is that they subscribe to the traditional model of “design, manufacture and service” with CAD at the core. “The problem there is that drugs and other process-based products cannot be designed using CAD applications, the technology at the very heart of discrete PLM.”
Since batch processing manufacturers don’t have anything analogous to the discrete world’s CAD, Neo PLM created it. According to Strain, it is the industry’s first digital process design and simulation tool that integrates directly with existing systems including manufacturing execution systems (MES), distributed control systems (DCS), data historians and even enterprise resource planning (ERP).
虽然总部位于康涅狄格州纽黑文的Neo PLM是一家初创企业，但该技术的开发实际上是在富斯（Pfizer）工作的许多年前开始的。劳勒（Strain）和他的团队正在设计一个位于商店地板上方的系统，并充当集成层，该集成层围绕该过程的数字定义统一系统。
Sitting between manufacturing operations and business management systems, the process design framework connects all aspects of the product lifecycle. During the design phase, life science companies can compare the impact of different processes and production scenarios to determine how to make the highest quality product at the lowest cost with the least environmental impact. There is no knowledge loss during technical transfers to shop floor systems. And during data analysis, execution data can be mapped back to the design in order to verify the recipe is being executed according to plan.
自从离开辉瑞和Neo PLM在2011年开始,Strain is catching the attention of large pharmaceutical companies as well as contract manufacturing organizations (CMOs). “We are getting traction by getting them to understand that process design should be the core of a PLM solution,” he said, noting other PLM players offer quality management and document-based approaches.
最终，药物制造商的增值是Neo PLM管理“实验室到患者”过程的能力。这包括绘制可能包括将制造业发送到CMO的整个药物开发阶段的过程。
“这里的中心主题是我们如何转移知识，因为产品从一个制造地点转移到另一个制造地点。技术转移是一个很大的话题，可以增强全球制造的能力，以满足监管要求的方式。”
This design-centric approach to process PLM unites scientists, process engineers and CMOs with a single version of the truth—something they’ve never had before.
