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.
Recognizing the problem—and the opportunity—many PLM vendors including Siemens, Dassault Systemes and Oracle are offering up PLM for process manufacturing. And, while these providers may have excellent document management and ways to blend virtual and physical models, they may be lacking something that newcomer Neo PLM brings 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).
While Neo PLM, based in New Haven, Conn., is a start-up, development of the technology actually began many years ago while Strain was working for Pfizer. Strain and his team were designing a system that sits above the shop floor and serves as an integration layer that unites systems around a digital definition of the process.
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.
Since leaving Pfizer and starting Neo PLM in 2011, 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.
Ultimately, the value-add for drug manufacturers is Neo PLM’s ability to manage the process from “lab to patient.” That includes mapping the entire process of drug development phases that may include sending manufacturing to a CMO.
“The central theme here is how we transfer the knowledge as the product moves from one manufacturing location to another. The technical transfer is a big talking point [as is] enhancing the ability to manufacture across the globe in a way that meets regulatory requirements,” said Strain.
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.