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Drugmakers look to a more flexible Pharma 4.0

Dave Perkon

A forum of industry veterans explored current challenges and possibilities, as well as future opportunities in the life sciences and pharmaceuticals manufacturing industries at the 2019 Emerson Global Users Exchange in Nashville, Tennessee.

"The automation industry is going through a big transformation process,” said Bob Lenich, life sciences marketing director at Emerson. “Industry 4.0 is an example. Life sciences manufacturing is transforming in a similar way with Pharma 4.0."

Market trends and business drivers such as cost pressures, uncertainty, market growth and more product classes feed the cost, feasibility, speed and quality of the products. The life-sciences industry also has embarked upon a digital transformation that is having an impact on flexible and continuous manufacturing.

Enabling technologies and capabilities are changing how life-sciences products are being manufactured. There are many opportunities and ways to accelerate the pipeline, and there are things that can be done to make it go more quickly from development to actual full-blown manufacturing.

Historically, the life-sciences industry has produced two things: product and paper. "Over the past few years, data is the new currency," said Lenich. "Now, they produce product, paper and data. Now, you need to take the data and do something with it, such as analytics. This is a growing activity that is exploding across the industry."

Global alignment of manufacturing standards

Derek Englert, lead of global automation at AveXis, provides development, implementation and deployment of a global automation solution across AveXis manufacturing network. “AveXis is a small-molecule manufacturer, and all our equipment is single-use,” he said.

From a DCS standpoint, we looked at our equipment and decided what could be standard across our five facilities. Most equipment is standard, but there are differences. We had control-module classes that we keep as global and maintain those across all of our sites. Phases and recipes will also be maintained across all of our sites. If the equipment modules are the same, we keep them as global but will use different equipment modules in each plant to account for differences in the equipment, but they must maintain the same interface to the phases. That means our control-module classes, phases and recipes are global."

Rex Polley, principal global automation engineer at Lonza, also commented on global alignment. "Lonza is a 122-year-old company with about 60 different plants, and it's important to note that we are a contract manufacturer. We do specialty chemicals up through large-molecule, small-molecule and cell and gene therapy. There is a lot of variety."

One of Lonza's large sites literally has a dozen plants in a campus with 55 DeltaV systems installed. "This one site is done with a single, global library, but a new plant has learnings that are fed back to the library where they can be maintained and fed back down," said Polley. "It's basically a single site acting as a global site."

A perfect standard is only perfect for one person, but good enough can be good enough for everyone," said Polley. "Sometimes it takes a lot of pushing to get people to understand that.” Even though it's not how one person would have done it, it will work and has worked.

Englert discussed the difficulties with decisions by consensus. "When you try to say, 'Here is how I'm going to approach this,' and then try to get all your stake holders at all your sites to agree, it goes nowhere. You do get conflicts as everyone has different backgrounds and has seen different ways that work. Again, you don't have to come up with something that is perfect; it just needs to work as well as possible," he said.

How AveXis approaches it is with a center of excellence where it has a team that takes in information from all the stakeholders, so people know their voices are being heard, continued Englert. "However, the team has the final decision on how it will be implemented," he said.

Automation enabling flexibility

In Englert's experience, he has often seen people who think automation reduces flexibility. "But automation can add quality and reduce paper," said Englert. "It really depends on how you automate the system, but paper can be very easy to change."

The executive leadership should clearly lay out what flexibility is needed, said Englert. "However, you cannot demand all the flexibility without any of the constraints," he said. "Meeting the business objectives is possible with automated systems."

Polley noted that as a contract manufacturer that has to fit a customer’s process into its facilities, Lonza's flexibility is inherent. "It's hard not to be flexible," he said.

"To non-automation people, it is necessary to explain the concept of templating, classes, instances of classes and aliasing in automation. Breaking these concepts down and putting them in non-automation terms for people allows them to quickly realize that automation can give them quite a bit of flexibility while still having structure."

AveXis has been unhappy with how some of their skids have been functioning, explained Englert. "They often have their own proprietary software system that we cannot touch," he said. "We can only interface to them through recipes. It limits what can be added and how to validate the system because you don't have full visibility.”

Because of that, AveXis is pulling some of its skids, removing the proprietary software and installing a DCS implementation. "These are currently lab-scale skids,” said Englert. "When it grows in scale, you need the flexibility in the process. The only way to do that is with a DCS."