Almirall’s MES/MOM director Francesc Luque is spearheading a digital transformation of the company’s pharmaceutical manufacturing, shifting from paper-based and disconnected systems to a fully integrated, “smart plant” model. In a role he assumed in early 2023, the main shift has been consolidating the company’s “Integrated Factory” program and finalizing the definition of its Manufacturing Execution Systems (MES) and Manufacturing Operations Management (MOM) system.
The journey will be the focus of a presentation at AUTOMA+ 2024 in Zurich scheduled for November 18-19. Ahead of his talk, Drug Discovery & Development spoke with Luque about the company’s digital manufacturing journey and vision for the future of pharma production. In the following interview, Luque shares lessons from Almirall’s MES/MOM implementation, discusses success factors for digital transformation initiatives in pharma, and offers his perspective on emerging technologies finding growing adoption in pharma manufacturing.
Given your background with MES/MOM systems, how has Almirall’s approach to MES/MOM implementation evolved since you joined?
Francesc Luque
Luque: First, let me tell you that the MES/MOM Director role is relatively new in Almirall. The position was created following its strategy (digital transformation is one of the pillars).
Going to your point… The main evolution since I joined has been consolidating our Integrated Factory program; finalizing the definition of our MOM ecosystem; increasing standardization across our pharma plants, and defining an operative model (from “disconnected”/sometimes paper-based into connected/digital).
Also, promote functional rationalization and help in IT/OT convergence.
…And tell everybody why MES/MOM! Explain the importance of harmonizing the relationships among functions/departments by increasing seamless integration: e.g., Planning/Scheduling (APS system) with production tasks (MES) and Lab QC tasks (LES), etc.
Almirall’s vision is the integrated/smart plant—a “single screen” to perform operations according to each role (e.g., MES in production or LES in the case of QC) without the need for manual data transfers or the use of “paper”.
How do you integrate these systems with legacy infrastructure, and what measurable impacts have you observed on manufacturing efficiency and scalability?
Luque: If we take the example of how we evolve obsolete infrastructures/systems, we approach it from a functional point of view.
For instance, if our “old” logistic/warehouse management system performs GMP functions, such as calculating “holding times” or expiration dates for the material/batches it manages, this function is transferred to our validated ERP system and disabled in the original system.
In fact, we have a phased plan to “minimize” the functions performed by obsolete systems until they are completely replaced by our “new MOM” ecosystem.
Regarding the coexistence periods, we have adopted middleware solutions to integrate our old systems and provide standardized operative functions (not just an interface or protocol) to our MES/MOM solutions.
With this, we can make a transition, getting early benefits from the new systems and also gradually retire obsolete systems, minimizing impact/downtime.
You’ve emphasized the importance of smart manufacturing and Life Sciences 4.0. How has Almirall integrated these principles into automating quality control processes?
Luque: As I mentioned earlier, primarily through the modernization and ongoing implementation of integrated systems with continuous and “online” monitoring of our processes and critical parameters. In fact, Almirall has a CPV (Continuous Process Verification) program in place driven by our Quality Assurance Director (Miquel Romero), who is also a leader in this field.
Additionally, how do you maintain an optimal balance between automation and human oversight to ensure quality and compliance?
Luque: We understand that automation is an opportunity for our staff to evolve from a “surveillance or guard” role into an “excellence and continuous improvement” role in quality assurance and compliance; gaining knowledge and with safer, more efficient, and faster review processes, which increase our effective capacity by reducing release times and ensure supply to our patients.
What key success factors have you identified for effective digital transformation in pharmaceutical manufacturing?
Luque: I consider the human factor to be the most important and key factor. That is, identifying digital leaders within our factories (please note! don’t confuse them with IT staff).
A digital leader has knowledge of the processes; usually belongs to the functional team where the transformation is applied (e.g., Operations) and helps the rest of the team to follow and adopt the changes. Therefore, identifying and selecting the team that will lead the transformation is key!
On the other hand, good communication both internally and externally. Make your initiatives “sexy” and the company attractive: offer challenging projects and suitable conditions to attract talent to the initiative; both young and experienced; from the company or the outside.
It is also key to identify and involve stakeholders early: Production, IT… and QA (never forget them!!). Gather the right sponsors and agree on a good governance and communication plan.
Finally, defining a vision, mission, and objectives for the initiative; a plan and phasing appropriate to the situation of each company and metrics to evaluate the results.
In your view, what emerging technologies or trends do you anticipate will most significantly impact pharmaceutical manufacturing operations in the near future?
Luque: Today, we are very aware of the topic of Big Data; AI/Machine Learning as a global trend for all industries. There is no doubt that it is a powerful tool already applied in multiple industries, including pharmaceuticals (for example, in R&D processes to accelerate the research of new drugs). In the case of manufacturing environments, there are multiple examples applied to energy efficiency; predictive maintenance…
Anyway… let’s go to the “core” of your question; that is, GMP-regulated manufacturing processes: In this case, the adoption time will be intrinsically linked to acceptance by regulators and the validation of AI algorithms. Therefore, the “near future” may be not so near… we’ll see.
In this regard, Almirall has already developed some use cases using AI in manufacturing and actively participates in renowned forums (e.g., ISPE) in contact with regulators to accelerate the adoption and acceptance process by authorities.
In any case, before reaching this point, it is necessary to have a connected factory; and more importantly, transform/expand the skills of the personnel so they can benefit.
With your experience managing large teams and leading complex projects, how do you approach change management during the implementation of new digital manufacturing initiatives?
Luque: As I mentioned earlier… to me, the human factor is perhaps the most important key factor. How good is a digital transformation if there is no adoption nor tangible benefit for the people in our plants?
Here are some points (some from lessons learned, others maybe “by the book”):
- Identification within the operational teams of the key people who will be our “Digital Leaders” and best ambassadors.
- Ensure their dedication to the project, even if it means their replacement in routine tasks while they’re engaged.
- The focus of resistance is usually not found in shopfloor personnel (e.g., operators) or top management; resistance in factories is found in some technical and middle-management positions. These are the ones to identify and manage.
- Listen to our shopfloor personnel and technicians who use the systems daily. They must be at the center of our design. Let them participate in early “prototyping” phases if possible.
- Give thanks to those who help adopt changes and propose improvements. If possible, offer some kind of reward. Also, be patient with the people or groups that have difficulties; select the right “ambassadors” to support them.
- Organizing a communication strategy appropriate to the phase of the program.
- Communicate, communicate, and communicate; at all levels and with all available channels: a digital initiative is not an IT project. It is a project for the entire organization; this must be explained from the beginning and to everyone.
- Communication shall explain the evolution of the impacted roles while implementing the program.
- Use games (e.g., apps) to communicate changes and the reasons for the strategies (in general, we humans like to play).
- Don’t create false expectations (this is not always easy…). If something goes wrong or has introduced some complexity, admit it and see how it can be mitigated (if possible).
- A training program appropriate to each group. Reinforce knowledge and accompany during the learning curve.
- A mix of young talent and experience.
- Monitor and measure the transformation of routine tasks: from manual workflows to digital workflows. Communicate benefits (example: reduction of paperwork by xx%).
Given the increasing role of data science in manufacturing, how does Almirall tap data analytics within its MES/MOM systems to drive decision-making and optimize operations?
Luque: Nice topic… Within our industrial digitalization program, the extraction of data from MES/MOM systems into our DataLake is an intrinsic part of the program.
Its subsequent processing, contextualization, and availability back to the operational level or to the appropriate stakeholders is part of the strategy.
For example, one of the initiatives we carried out (called “digital worker”) has been the “digitalization” of the changeover process: including visual aids for the personnel preparing and adjusting machinery. The system also records the activities performed, in what order, the time taken, etc.
Thanks to the extraction of information from the system, contextualized with the manufacturing program and observing data derived from personnel behavior, our technical staff led by our operational excellence group has been able to identify several points of improvement and thus reduce format change times.
Filed Under: Drug Discovery and Development, Industry 4.0
