The Module Type Package Wants All Your Equipment To Start Talking

A conversation with Scott Clark, Sanofi

The success or failure of robust Pharma 4.0 implementation hinges on, among other things, your equipment’s interchangeability within automation systems.

Experts, including Sanofi Head of Manufacturing Automation Systems Scott Clark, predict an impending future of movable process skids replacing built, static infrastructure. But for those modular components to work effectively, first, they must be plug-and-play.

Clark spoke at the 2025 Bioprocessing Summit about a standard, currently in development by the International Society for Pharmaceutical Engineering, called the module type package (MTP), which aims to guide process development teams.

We caught up with Clark after his talk for key takeaways. Here’s what he told us. Dialogue has been edited for clarity.

You spoke about Pharma 4.0 and this transition to modular manufacturing systems, specifically focusing on the module type package platform. Could start by describing the MTP and its intent?

Clark: So MTP means module type package and it's really a standard at its heart that allows us to modularize process equipment assemblies or process skids so they can be plugged into our automation systems and our platforms and then be immediately usable in the framework of your process flow.

Think of it as plug-and-play, much like a computer mouse is plug-and-play into your computer. It provides the ability to plug something like a filtration skid, for example, into your automation platform and immediately begin to configure it as building blocks or Lego blocks to create your process recipes.

We know that the International Society for Pharmaceutical Engineering (ISPE) is working on a process implementation guide. Where does that stand? When can we start to see some real guidance on how to actually put this into practice?

Clark: That's exactly right. The implementation guide for MTP is being published by ISPE. It's currently undergoing the internal reviews. It provides, currently, more than 18 different use cases, anywhere from a headless scale, for example — simple process equipment — right up to very complex process modules such as a lyophilizer, as well as even a line management system, which would integrate all the process equipment, steps, or units or skids that would be required from end to end to automate the bioprocessing process.

One thing that stood out to me, Scott, was you talked about why this excites you and why it matters to you. Can you talk about all the subject matter groups that are affected by this?

Clark: It impacts everyone who contributes to bringing medicines to life for our patients. One of my passions is to be able to consume and use that data to connect to our advanced data analytics and the AI capabilities we don't even know about yet. And our MTP standard allows you to contextualize the data at the lowest level so that data can be immediately known by the higher-level systems, which then allow our consumers and data scientists, for example, to utilize the data.

And that was really a light bulb moment for me — the additional ways and how important it is to be able to learn and understand the MTP standard so it can enable capabilities we don't even know about yet.

Some of the end users, if you will, or people who should know about MTP, would include, of course, process engineers and scientists, process development folks, and automation personnel.

Also, your qualification and validation personnel can leverage MTP to reduce their efforts by up to 60%. We also have data scientists and any other end consumers of that data who need to analyze how well a process is running, how to optimize it, and also how to bring medicines more quickly to our patients.

About The Expert:

Scott Clark, a chemical engineer, is head of manufacturing automation systems at Sanofi with expertise in manufacturing and quality systems and process optimization. At Sanofi, he focuses on new technology operationalization. Previously, he held leadership roles at Bristol Myers Squibb. Before that, he was a project engineer at Merck.