Lonza - Collaboration and feedback: Driving software innovation in the pharmaceutical industry

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Collaboration and feedback: Driving software innovation in the pharmaceutical industry

PROJECT PARTNERS

Collaboration Driving the pharmaceutical

Collaboration and feedback: Driving software innovation in pharmaceutical industry

Robert Lutskus, Digital Operations Technology Director at Lonza on the company’s innovative approach to software development in the pharmaceutical industry to serve end users.

Founded in 1897 in Switzerland, Lonza has become one of the world’s largest healthcare manufacturing organisations, spanning five continents and building technological innovations in the fields of biologics, small molecules, cell & gene therapies and capsules & health ingredients.

oining us from Lonza is Digital Operations Technology Director Robert Lutskus, highlighting the company’s innovations in software development. To begin, he explains the collaboration behind the company’s successful production strategy.

“We approach our product strategy with a collaborative mindset,” explains Robert. “Our team members have worked in a huge scope of areas across the pharmaceutical industry, so when we develop our strategy we’re able to take a broad view.

“We’re always looking to see if there is an area of the market not being serviced effectively – maybe something is being done poorly, or needs to be executed on a larger scale. Once

we’ve identified that area, we sit down and look at how we can satisfy the demand, and where the industry currently is on that journey. From there, we map out what needs to be prioritised.”

A crucial element of ascertaining the state of the market, Robert explains, is listening to the end user.

“I think the value of this feedback cannot be overstated, particularly from our existing customers,” says Robert. “Each of our customers has their own specific needs, so we can look at that for a more personalised understanding of what the consumer is currently looking for. If we can see our customers saying that they wish certain processes would be easier, or a piece of software has bugs that need fixing, then that’s what we’re going to

focus on. Some of our best ideas come from our customers.”

Over the years, Lonza’s approach to developing these new products and offerings has shifted with the emergence of new technologies. With thirteen years behind him in informatics leadership roles, Robert’s understanding of how to implement these new innovations has been shaped by a well-developed understanding of the customer’s needs.

“At the beginning of this year, my role shifted to focus more on

strategic operational technology (OT),” says Robert. “However, prior to this I managed various aspects of the informatics portfolio, primarily MODA®, for around 13 years.

“Innovation from an informatics perspective is driven by the emergence of new technologies and evaluating the changing landscape. The industry is moving on from traditional, monolithic server-based hardware to cloud-native SAAS/SAS microservices.

“It’s crucial to strike a balance when implementing these new innovations. You can’t just flip the switch overnight.

“What we’ve been good at is innovating at a pace to ensure that we continue to serve our core market while keeping opportunities open for new markets.

“There’s an understanding that all of the cloud-based technologies that are coming onto the market are purely cloud-based. For us, the level of data risk to our customers with this model isn’t always acceptable. While offering a hybrid approach means there are increased costs, it satisfies our customers because we’re driving them towards exactly what they want – they don’t have to compromise.”

However, Robert emphasises that looking at this from an OT perspective requires an entirely different mindset.

“When we think about traditional IT, it’s about making sure your wifi works and your servers are on, things like that,” says Robert. “OT is a specialised and segregated subset of IT systems, focused on manufacturing and quality automation and systems.

“So from an infrastructure perspective, you’re spinning up a segregated network that the regular business users can’t access. This provides an additional layer of security, but it also means that there’s an additional layer of coordination required.

“My team is focused on strategically outlining what systems should be put

“Ultimately, the goal of any system in the pharmaceutical industry is to serve patients faster”
Robert Lutskus, Digital Operations Technology Director

in place, how they should be put in and how we should select them. We have a variety of sites within our business unit that we’re looking to align within the global business.

“So when you’re one business unit like us building a huge variety of products – from cell & gene therapy to biologics to media and software – you need flexibility to service these very different modalities and manufacturing technologies.

“We have to ensure that we’re selecting systems that are fit for use for us, and then also looking at road mapping what system we should select in terms of the value it’s bringing to the business.

“To assess this, we’re using the digital plant maturity model to see how digitally mature our plants are and how much paper is involved in the process. Our aspirational goal is to

be 100% paperless throughout our facilities. To work towards that, we’re working out what projects would be the most beneficial to begin the process of being completely paperless – for instance making our logbooks and batch records paperless with MODA-ES®, removes significant downstream handling of paper, simplifying and improving the quality of the release process.

“Ultimately, the goal of any system in the pharmaceutical industry is to serve patients faster. So the question we’re asking is: how can we achieve that, and what are the big bang items that will help that happen?

“Particularly in cell & gene therapy manufacturing, when a drug has been produced it will typically go into cryo until it can be released. If anything goes wrong, you’re putting patients directly at risk, so we need the controls in place to ensure that these processes are conducted safely and efficiently.”

With such high stakes, the company has to ensure they have high-quality partners, particularly when it comes to hardware.

“We rely on our partners for hardware production,” says Robert. “They create hardware that is

REVOLUTIONISING ENVIRONMENTAL MONITORING

LIGHTHOUSE WORLDWIDE SOLUTIONS COLLABORATES WITH INDUSTRY LEADERS

In the advancing world of pharmaceutical and biotech industries, the seamless integration of data is critical for success. Lighthouse Worldwide Solutions, a global leader in particle monitoring technology, has partnered with prominent Laboratory Information Management Systems (LIMS) providers, including Lonza, to redefine environmental monitoring (EM) through their innovative MODA-EM system.

A Collaborative Approach

This partnership is built on a shared commitment to excellence and innovation. Lighthouse Worldwide Solutions’ ApexZ portable particle counter is the cornerstone of this collaboration, seamlessly integrating with the MODA-EM system. The innovative unit has proven indispensable across numerous projects, offering reliable data collection through both wired and wireless connections. Industry giants’ trust in the ApexZ’s data accuracy and overall quality underscores its technical reliability.

Data Integrity at Its Best

Data integrity is non-negotiable in the pharmaceutical and biotech sectors. Companies rely on accurate, realtime data to make critical decisions. Lighthouse’s dedication to precision ensures that the data transmitted to MODA-EM is trustworthy and consistent, directly impacting product safety, regulatory compliance and operational efficiency.

Global Impact and Adoption

The partnership between Lighthouse and LIMS providers has set a new gold standard in the industry. The MODA-EM system has been widely adopted by major pharmaceutical companies worldwide, not just for its compliance capabilities but also for its ability to advance EM monitoring programs, reduce costs, and provide comprehensive insights into manufacturing operations in real-time.

A Future of Excellence

Together, Lighthouse Worldwide Solutions and pharmaceutical companies using the leading LIMS providers such as Lonza and LabWare continue to push the boundaries of what’s possible in environmental monitoring and quality control, ensuring that data integrity remains the cornerstone of pharmaceutical and biotech operations. But it doesn’t need to stop there. Lighthouse has been contacted to work with numerous pharmaceutical companies using a variety of LIMS providers, and the beauty of the ApexZ is that our API can integrate with them all.

Contact us today to learn how the ApexZ can transfer data to your Laboratory Information Management System Today.

“We have a variety of partners, all of whom excel at what they do. By allowing them to do that, we’re able to build a mutually beneficial relationship”

fit for use in their spaces – when we’re talking about the specifics of pharmaceutical manufacturing, there are very specialised instruments needed to produce these products.

“Rather than trying to recreate the wheel, we’ve taken an agnostic approach to partners. We have a variety of partners, all of whom excel at what they do. By allowing them to do that, we’re able to build a mutually beneficial relationship.”

One such relationship is with Particle Measuring Systems (PMeasuring).

“PMeasuring offers devices that are incredibly easy for the end user to manage,” says Robert. “These devices come in two different formats, offering a fixed particle measuring system and a portable particle measuring system. The fixed system runs alongside the manufacturing line to make sure

“Lonza facilitates learning by having incredible leaders in place. I’ve had the benefit of working with a lot of those leaders. The core of my team has been together for the better part of 14 years, and they’re all incredibly talented people”

there’s no risk of contamination, while the portable system does the same in other areas of a manufacturing space.

“By working collaboratively with PMeasuring, we’ve developed application programming interfaces (APIs) where we can control these devices so they send us the data in a secure and compliant manner.

“Climet has also been a strong partner for us, because again, they have the flexibility to let customers pick from a wide range of devices and can select which are best for them. This then allows us to develop a set of drivers

which can be used across a suite of devices.

“They’ve done a really good job of providing us with the ability to create something for every single device without significant overhead. Thanks to Climet, we just have to tweak configurations rather than reprogramming an entire interface which saves us a lot of time.

“They’ve worked closely with us to ensure joint customer satisfaction –we’ll go on calls together and walk customers through configurations, really helping them understand the

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strengths of the technology and how it can best be implemented.”

“Lighthouse has been a long-time collaborator, as well,” adds Robert. “They have developed a number of very popular and user-friendly portable particle counting devices, that we were able to integrate with early in its development lifecycle. They have worked collaboratively with Lonza and our mutual customers on incorporating user feedback for updates to the firmware. This relationship has allowed us to provide those mutual customers with a robust configurable interface.”

Another key partner for Lonza that Robert celebrates is life sciences

technology company Rapid Micro Biosystems.

“Rapid Micro Biosystems offers a Growth Direct system, which is a dual chamber incubator with a high-tech camera in it,” explains Robert. “With this system, once we’ve collected the samples they will automatically be incubated and read – so unless there’s something wrong with the samples, we don’t ever have to see them again.

“Before, when we were doing this manually, we had to put them in an incubator, retrieve them and key in each entry, either with a scanner or by typing them up. So this system has dramatically increased the level of

automation we have in our end-to-end process.”

Hardware like this combined with Lonza’s cutting-edge software brings new capabilities to the table, allowing the company to automate processes at new levels.

“We use this alongside our MODAEM® software, which automatically transfers the payload of the samples that we’re physically putting in the instrument,” says Robert. “This incubates them at the proper temperature and for the proper time, taking high-resolution pictures of the plates and doing early detection to see whether or not there are bacteria on it.

“Once it goes through, the software will then determine whether or not there’s going to be growth on that plate. If there isn’t, it discards that plate for you and if there is, it will notify you and pick back up the workflow autonomously.

“We’ve implemented the combination of MODA-EM® and Rapid Micro Biosystems at a number of Lonza facilities, which has driven a tonne of value – in terms of our end users and in terms of the ROI on our sites.”

As Lonza moves forward, Robert emphasises that the work achieved is a result of the team’s dedication to the company and commitment to learning.

“Lonza facilitates learning by having incredible leaders in place,” says Robert. “I’ve had the benefit of working with a lot of those leaders. The core of my team has been together for the better part of 14 years, and they’re all incredibly talented people.

“It’s one of those things where we’ve all grown together, and we’re all deeply invested in each other and the technology. That’s what makes us different. This has been all of our careers for a very long time, and we continue to want to see it be successful in whatever manner it needs to be.”

Learn more about Lonza here.

Turn over for Added Value with Robert.

ADDED VALUE

“I’ve been blessed in my career with some great mentors,” says Robert. “The original founder of MODA Technology Partners, Mike Goetter has been my direct manager three different times in three different roles. He’s someone who’s been invaluable in my career development, and taught me so much about the business.

“Another manager was Orla Cloak, who’s now the Business Unit Head for Bioscience. She’s an excellent mentor, and she helped me progress in my career in ways I hadn’t even considered before. Mike drove my technical development and helped me develop an understanding of the business, but Orla taught me how to become a better leader.

“My current manager Jay Housman didn’t know a lot about this space initially, because he comes from a background in digital marketing. When I first started working for him, I wasn’t sure what I what our relationship would look like and how it would benefit me, because he’s younger than me and from a completely different part of the industry, but he’s absolutely brilliant. Since I started working under him, I’ve learned more than I could even quantify.”

Lessons learned

“When I started at the University of Delaware, I decided to walk onto the football team,” says Robert. “I was short, and I was slow, but I participated in spring practices. I was given a set of activities for the summer to practise. I didn’t do them, it was evident I didn’t do

them, and I was immediately cut from the team.

“So I took that lesson and said ‘Alright, I’m never going to be outworked again. I’m going to overcome,’ I was never going to be a professional football player, but if I’d worked harder then I wouldn’t have ended up in the coach’s office on day one. Going forward, I’ve always tried to work harder, be more available and drive whatever it is that I’m working on.

“One day, when I was working at ImClone Systems, my boss sat me down, and she said ‘I love your work, but I would never hire you again.’ She told me that I don’t work with people, I work through people – that I get done what I need to get done at any cost.

“I had crushed so many relationships with my work ethic, and I realised that I needed to be different. After this, I went on what I jokingly called my apology tour, where I made contact with the people I had worked with during my time at ImClone and repaired my relationships, so that when I left, I left on very good terms with all of them.

“If I had never had that conversation with my former manager, I never would have understood the value of those former relationships. It completely changed my perspective. Now, I try to maintain relationships very differently now, and work in a new way. Not only has this helped me develop who I am as a leader, but also who I am as a person.”

Connect with Robert

bioscience.lonza.com

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