The life sciences marketplace is changing faster than nearly any other industry. Gone are the days when companies focus on a single treatment to drive their entire business. Today’s life sciences manufacturers are challenged to bring new treatments to the marketplace as quickly as possible—a trend that was magnified during the COVID-19 pandemic.
As a result, innovation is key today. And innovation requires technologies that enable flexibility. In a recent article in Processing magazine, Emerson’s Kristel Biehler shares how today’s life sciences innovators are unlocking speed to market through better decision making and faster technology transfer. Kristel explains,
“Supporting better decision making and faster technology transfer means rethinking the way data is handled across the product development lifecycle. It starts with building a culture of standardization using software tools supporting easier technology transfer across the drug development cycle.”
The challenge of technology transfer
For years, technology transfer has been one of the slowest parts of the treatment development pipeline. While most organizations have moved away from paper records to focus on digital documentation, critical information about treatment development and manufacture are still siloed in different systems. Typically, different areas of research and development use their own proprietary software packages and databases, which are, in turn, different from those used in manufacturing. Moving data between these groups often means performing complex conversions or custom configurations that waste time and money.
Software is the solution
Modern software has provided a solution to the technology transfer conundrum. Process and Knowledge Management™ (PKM™) can be used by every group across the development and production chain, electronically capturing every decision made. PKM software collects the data in a central location for easy collaboration between individuals and across functional groups. Internal calculation engines manage process parameters and calculations automatically, making information more intuitive and accessible.
Moreover, PKM software uses templates to drive standardization. As Kristel explains,
“Teams can use common definitions and keep them up to date over time. For example, using these templates, development teams can push changes to multiple recipes at one time, saving many hours of manual editing. Moreover, the PKM software tracks the changes, providing a clear audit trail and displaying how the change impacts each recipe.”
That standardization not only makes it easier to move a treatment through each stage of the development lifecycle, regardless of scale-up or differing equipment needs, but also makes it easier for to solve problems during and after manufacture. Kristel shares,
“If a new treatment has a problem after release, knowledge management across the lifecycle provides easy access to the data needed to quickly solve that problem. This is particularly important because when something goes wrong, everything is put on hold until the organization can provide a solution and its associated support data.”
Simplifying the move to manufacturing
The most complex and time-consuming technology transfer typically occurs as a treatment moves from R&D to manufacturing. The process can take months or even years when performed manually. But PKM software builds a bridge to close that gap. The most advanced PKM software offers easy integration with distributed control systems like the DeltaV™ DCS and manufacturing execution systems (MES) like Syncade. As Kristel explains,
“In a few short steps, the PKM system seamlessly pushes sequence of operation and parameters down to these systems, ensuring downstream teams know exactly what to purchase, and how to manufacture drugs based on the pre-established link from recipes to the execution system.”
Emerson has tested its PKM technology with the DeltaV DCS and Syncade MES and found that under the right circumstances, automating technology transfer in this way can help reduce a new treatment’s time to market from 10 years to 2.5 years.
To learn more about PKM technology, including ways that it helps support compliance and personalized medicine, you can read the article in full at Processing magazine. You can also see Emerson’s PKM technology on display at this year’s #EmersonExchange customer event from Oct. 24-28 in Grapevine, Texas. I hope to see you there!