The organizer of the Paperless Lab Academy® Isabel Munoz Willery had the pleasure of interviewing Miguel Alvariño Gil, Manager Quality OpEX at Lonza. A long-awaited presentation on their automation project, now completed and ready to be shared with the audience.
They talked about the enormous impact the pandemic had on digitisation projects. They talked about the delicate aspect of hiring qualified staff when the business urgently needs to grow, and looked into the future and hypothesised about what the situation in the labs will look like from a digital point of view.
We share the interview here:
Q –> The Paperless Lab Academy® is celebrating 10 years, an opportunity for retrospection. If you look back 10 years, which technology and/or concept has enabled the digital transformation for laboratory processes?
A–> I would say that the pandemic had a huge impact. 10 years ago, everyone was focused on implementing a LIMS, and today everyone has one installed. I think today it’s all about systems interfaces, limiting the use of paper and human intervention.
The pandemic drove this drastically and was the biggest catalyst we had. Suddenly people were sent home and asked to work remotely and yet businesses were expected to function at their best. I am part of the ISPE robotics and automation work team. When we started 3 years ago, there were only 15 of us from Switzerland, Germany, and Austria, now we have to limit the number of participants when we organise events.
Q–>What has changed then? Have finally the top management realized there was something to be done regarding Digital Transformation?
A–>They have indeed realised that they would be in great trouble if they do nothing. The competition does not stand still, and they could fall behind very quickly. For instance, if there were reservations at first, working from home is now a fact of life. And it will stay that way. I myself now only go to the office 2 days a week. Before, it was neither accepted nor possible.
It is also a plus point for new applicants in job interviews. When they see the roadmap of our projects and know that they could have something to do with it, it is a strong introduction and positioning as a modern company.
Let me give you an example of the impact of the pandemic. In February 2020, I led the lab digitisation project, and we introduced the RMN lab project. It was the very first lab to be fully digitised. The methods and processes were pretty standard, so we decided to start with that.
At the presentation in February 2020, the comments were just “Oh nice”, “maybe” … A month later the question was, “What do we need to do to convert all the other labs?”
The fact is that the head of this laboratory could not come to his workplace during the pandemic for health reasons. However, since we had fully digitised his lab, he could access all the necessary information: raw data, weights, methods used…So he could work out the resource allocation remotely, he could lead the team, decide on analysis priorities, release results, and approve reports.
This lab would have been shut down if we had not been ready before the pandemic.
I have taken on a different role now, but the path is set and for everyone at Lonza, this is the way to go from now.
A–> In summary, you see a change in mentality that was accelerated by the pandemic, rather than by new technology or concepts.
Q–>Well, technology is a given. It comes down to the management team. Managers have a certain view, a certain strategy and even a different culture compared to another company, which leads you to focus more on one aspect or another.
For example, at Lonza, we will soon be doing software validation online. If you had told me that 5 years ago, I would have laughed out loud. That just happened because of the pandemic. Validation requires 2 people in parallel, which can be perfectly realised remotely from a computer which allows to see and record what the other one is doing. This is already happening with software validation, and it can soon be the case with validation of analytical methods.
Of course, no one has the capacity to be fully digitised today, and not everything needs to be digitised.
The processes with more return of investment will go first. Each company will have its own decision-making strategy based on quality, effectiveness, competitiveness, business revenue, … Some processes won’t be of much interest to invest into their digitalization, so there won’t be need to go for all.
One of my university friends with similar responsibilities works in a company that has gone through several acquisitions. 4 years ago, she managed to build a team to harmonize the 11 LIMS they had to maintain. They were able to identify the systems they wanted to work with and in the meantime new acquisitions with new LIMS came in. There will always be situations like this that one is confronted with. The point is to be ready to work for integration and harmonisation.
A–>Can you tell us a bit more about your career pathway?
Q–>My professional career started in quality control at Takeda. I then moved to the laboratory at Lonza, where I even worked as an analyst. When I moved to the laboratory digitalisation team, it was very useful to bring in my knowledge of laboratory processes.
In 2021, I moved to a group called Quality Innovation, now Quality Operational Excellence. We work to make the labs as efficient as possible.
There are three areas we work in: Lean Lab, Automation of test processes (bots with Power Apps, software analytics, data integrity, artificial intelligence…) and Automation and Robotics.
A–>How much do you interact with Manufacturing with those projects?
Q–>More and more. In the beginning these projects were self-sufficient, within the laboratory and for the laboratory. There is always a moment when we have to interact with operations, but not only. We now have a lot of interactions with environmental, health and safety, and with quality assurance and qualification.
Because nowadays we do not rely so much on standard equipment. Sometimes, for example, we work with robots that are brand new or have been specially developed for us.
We have learned a lot about qualifying this new type of equipment. We now have an addendum to the standard qualification of equipment that we can use.
A–>What does industry 4.0 means for you and your team at Lonza?
Q–>We do not talk so much internally about 4.0. It’s a nice concept, nice for the presentations, books, and theoretical definitions. Ultimately, you have to put it into practice. We knew we were going to grow a lot, build new plants, and we never expected to grow so much during the pandemic.
The main problem was that we realised we had to hire a lot of people without finding so many qualified people. So, we started to think about how we wanted to proceed in quality control and looked at different projects and areas that could be improved through automation.
Some projects were discarded because the technology was not yet available, others because as CMO we had to inform our clients to confirm their support and they were not always ready for innovative approaches.
So, we started with microbiology, because the methods are limited, about 15 standard methods from the pharmacopoeias. Thank you to all the knowledge we gained from this project, we are now confident that we can transfer this experience to other areas.
If we had started with a more complex and less standardised area, we would not be where we are today. Thanks to this “simple” project, we now know better how we want to proceed.
A–>Regarding your presentation at PLA2023 Europe ” End-to-End Automation, Digitisation of Bioburden Analysis in a GMP Environment”, what were the primary goals you wanted to achieve?
Q–>In my presentation, I will be very prosaic, because the goal was to overcome the need to hire a large number of qualified employees. The Swiss and German markets are saturated. It is impossible to get lab technicians on a constant basis. So, we worked out a project to limit the number of staff needed, purely out of cost avoidance.
At the beginning they were 3 separate projects, but then we realised that they had much more in common and we could work them out together. In the end we achieved much more than expected and eliminated every paper-based process.
A–>In your opinion, how far are you from fully digitised QC processes? is it your final goal?
Q–>Definitely not for everything. We are considering more and more projects for digitaslisation and automation, but as I mentioned earlier, there will always be processes that are not worth the investment.
Even a fully automated process cannot cover a punctual high demand of analysis. Investing in a second or third robot to cover such a selectively high demand is not worth the money.
The decision is always business-driven.
There are two main reasons why you decide to go digital: firstly, because of the business benefits and secondly, because otherwise you will be out of the market not only because of the competition, but also to comply with regulations.
A–>What do you foresee for the next 10 years?
Q–>I’ am sure that many things will change because new technologies will emerge. At Lonza, we have a roadmap of features that are already there and that we could install or test.
Some of them have not yet been introduced in the pharmaceutical industry. They are being tested at universities and may not come to market for 3 or 5 years, or at all. We keep a close eye on what is being tested. Ultimately, this topic of digitalisation and automation prepares you for everything that has to do with artificial intelligence. We have ideas, but we cannot predict where we will be in 5 years. It could look very different in terms of business intelligence.
What we are doing today was science fiction 10 years ago. In that sense, we are pioneers.
The automated mobile robots that do the sampling are mentioned extensively today. They collect the sample at the production site and pass it on to another robot that takes it to the lab. This is just a start, but things are happening. There are also many publications about the “Lab of the Future”. Probably not everything will be implemented or possible, but we are facing a huge learning curve. Any company that is not working in this direction will be left behind.
I see 5G as another important change. I think in the pharmaceutical world you could look forward to dedicated communication lines for quality control, operations, and quality assurance, which would make everything much more efficient.
