Modular facilities are a key enabler of speed to market in life sciences. As organizations try to bring new therapies to market faster, those therapies require a wide variety of equipment—many of which are new to the process. These new machines must not only work together, but also must integrate seamlessly with existing process equipment and systems to keep production nimble.
In the recent Emerson Exchange Virtual Series life sciences forum on modular plug and play, hosted by Bob Lenich, Emerson’s global business director for life sciences marketing, a wide range of experts shared a glimpse into the future of biopharma. Panelists detailed how NAMUR’s MTP will drive speed to market by simplifying the infrastructure companies use to move from research and development to full-scale manufacturing.
The need for flexible facilities
A key part of the challenge of modular manufacturing is ensuring equipment works together interactively. Today, this takes a lot of time and effort, both to make sure any given setup is going to work, and to confirm that it’s going to connect into the existing system. And even when facilities get machines up and running together, they need to maintain them and ensure they continue to work together as processes, equipment, and even platforms continue to change and update.
Building a plug-and-produce environment
The plug and play initiative for life sciences manufacturing is a set of standards incorporating both data models for the most common unit operations in biopharma with a standard communication protocol (OPC UA) and a handshaking protocol developed by NAMUR (MTP). Together, these elements allow OEM equipment to communicate seamlessly and receive commands from a supervisory control system.
Gene Tung, executive director for manufacturing IT at Merck, explained,
By promoting these standards, we promote interchangeability of those unit operations as well as the ability for data to flow to higher-level systems for batch release, or for analytics or other purposes
Life sciences organizations using plug and play technology will use this standardization to speed their processes. As they spend less time reinventing the baselines of production, they can focus instead on improving quality, performance, and repeatability, all critical elements to increase speed to market. Burkhard Joksch, technology consultant for Sartorius Stedim Biotech added,
I think in the future MTP will be the standard to allow modernization of plants—this ballroom concept.
Increasing the speed of projects and speed of implementation will reduce or eliminate two key barriers to automation qualification. When the industry comes together to define common protocols that enable plug and play communication, life sciences companies will be able to take automation qualification off the critical path and deliver medicines faster. Gene commented,
In every facility startup I’ve been a participant in, automation qualification has been a critical step. And specifically, it’s those last few pieces of equipment that needed to be connected because they have important data for batch release.
Strong participation makes a strong standard
One of the key things that makes NAMUR’s MTP standard such a robust solution is the breadth of collaboration of many industry participants. Forum participants Gene Tung and Rex Polley, head of global automation at Lonza, expressed how contributions from end users, equipment manufacturers, and automation solution providers will help the solution take off as an industry standard. Rex added,
Pretty much any of the big names from the various biopharmaceutical companies either are currently or have been involved.
There are several pilots of MTP going on throughout the industry, and it won’t be long before organizations begin to adopt the technology to drive faster speed to market. Kelsey Hill, Emerson’s life sciences marketing manager explained,
It’s happening now. It’s starting to get rolled out and it’s only going to get faster from there.
Results speak for themselves
The engineering and time savings enabled by plug and play technology will translate into significant cost benefits. Gene explained,
This type of engineering—the automation, commissioning, development qualification—is critical path to the overall facility qualification. If your facility can be qualified faster because you’ve reduced time at a critical path step, you actually got your facility up in a shorter amount of time. And if you’re first to market, that translates to huge revenue benefits.
Emerson’s tests of MTP have shown engineering savings of 50% or more over what testers would traditionally take to integrate a piece of equipment.
To learn more about the way MTP is improving flexibility in pharmaceutical manufacturing, register for the Emerson Exchange Virtual Series and watch the forum in its entirety. Emerson Exchange content is available on demand to registrants.