July / August 2022

Communities of Practice Profiles: Meet the PAT-LCS CoP

Marcy Sanford
Communities of Practice Profiles: Meet the PAT-LCS CoP

ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each other. Professional Communities of Practices for Emerging Leaders and Women in Pharma® provide the opportunity for members to network with colleagues from around the globe. Technical Communities of Practices offer networking opportunities and provide a connection to collaborate with international peers on topic-specific content. Pharmaceutical Engineering® is initiating an ongoing series of Communities of Practice profiles, starting in this issue with the Process Analytical Technology & Lifecycle Control Strategy (PAT-LCS) Communities of Practice.

The PAT-LCS Communities of Practice has more than 3,000 members and is led by a diverse steering committee, with representation from Central Europe, Turkey, Singapore, and North America. The group focuses on developing content to benefit members of ISPE in relation to the use and standardization of PAT, and the field of life-cycle control strategies. Members from the Steering Committee can often be found at ISPE’s Annual Meetings in Europe (see Figure 1) and the US presenting on their latest initiatives and outcomes.

The Communities of Practice contributes to conferences, often with separate sessions, and most recently has hosted the webinar “Unravelling Manufacturing Control Strategies: Maturity Model and Case Studies.” Members from the steering committee are also leading the team writing ISPE Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality Monitoring Systems, which, as the most recent output of the Communities of Practice, will include a control strategy maturity model it developed. Line Lundsberg-Nielsen, PhD, Managing Consultant, NNE, and Chair of the PAT-LCS Communities of Practice talked with Pharmaceutical Engineering® recently about the Communities of Practice. She said anyone who is interested in learning more about PAT-LCS concepts can benefit from joining the Communities of Practice. Lundsberg-Nielsen sat down with Pharmaceutical Engineering® to answer a few questions about the Communities of Practice.

Figure 1
Figure 1: Line Lundsberg-Nielsen, CoP Chair, and Steering Committee members Christian Wölbeling (center) and Eric Urau (right) at the 2022 ISPE Europe Conference.

What Are the Communities of Practice’s Areas of Focus?

As our name suggests, we focus primarily on PAT and the life cycle of control strategies in commercial manufacturing. We’re looking at advanced control strategies based on real-time PAT applications, modeling, and simulation tools and consider the evolution and application of the control strategy throughout the product life cycle as more product knowledge and process understanding are captured.

When the Communities of Practice was launched in 2005, it was purely focused on understanding the role of PAT and its applications for gaining process understanding versus applications for process control purposes. Following the trends of that time, the focus was particularly on small molecules; for example, active ingredient synthesis and tablet manufacturing.

The pharmaceutical industry since then has adopted many of the PAT concepts into daily routine and today it is very difficult to run a continuous manufacturing process without PAT as a tool for live monitoring of product quality and process performance. Different PAT analyzers installed in the process equipment combined with mathematical models are therefore being used extensively to control the output of a process step, typically monitoring critical quality attributes (CQAs) of the intermediate and/or finished product, providing a more efficient and faster quality control in contrast to analyzing samples in the laboratory. Many of the technologies we use are based on spectroscopy, such as NIR, MIR, and Raman, just to mention a few of the more popular ones.

Obviously, the knowledge and experience gained with small molecules has been translated to large molecule processes—so has the interest of the CoP. Currently this is one of the key drivers in the PAT portion of the Communities of Practice, as large molecule processes are of higher complexity.

The control strategy is important because it’s the recipe that tells you how to make your product, how to produce it, how to control it, and how to get the right product quality.

The LCS portion of the Communities of Practice was a logical extension of the existing working topics; as with the capabilities of PAT, additional focus was needed on the control strategy as a whole and how it can be maintained and improved throughout the product life cycle to accommodate for variations in, e.g., raw materials and wear and tear of process equipment and not only on the PAT technology. The scope and name of the CoP was therefore changed from PAT to PAT-LCS. This was also an attempt to support the—at that time newly born—ISPE Pharma 4.0™ initiative, where the control strategy plays a major role.

Why Is the Communities of Practice’s Work Important to the Pharmaceutical Industry?

The control strategy is important because it’s the recipe that tells you how to make your product, how to produce it, how to control it, and how to get the right product quality. What we want to do is to have an inline and real-time-based automated control strategy by applying data analytics and modeling tools to both PAT data and process data, so the process can be adjusted and optimized in real time, ensuring that patients always get the same high-quality medicinal product within the shortest time. We believe that by focusing on real-time control and improvement, the industry will be able to achieve this goal.

This is the direction that more companies are taking now. It has taken us many years to get where we are today, and there is still a lot to do to encourage and support those companies that have not started yet. Finally, we also need to make sure that the evolution is mutually recognized between the industry and regulators.

Figure 2
Figure 2: Opening slide from the “Unravelling Manufacturing Control Strategies: Maturity Model and Case Studies” webinar.

Tell Us about the Webinar the Communities of Practice Presented in March 2022

We were originally scheduled to present this research at the 2021 ISPE Annual Meeting & Expo, but most of the presenters live in Europe and were not able to travel to the conference. To share our work with the community, we decided to convert this into a webinar instead (see Figure 2), “Unravelling Manufacturing Control Strategies: Maturity Model and Case Studies.”

Control strategies are becoming more important, and companies must have many different strategies in place to secure robust manufacturing, including monitoring and review of manufacturing data to ensure product quality throughout the product’s life cycle. Our Communities of Practice examined the different impact areas and strategy implementation, how they are related, and determined the benefits of different strategies in terms of speed, efficiency, and agility. We then asked the question, “What are the capabilities required for applying these control strategies?”

In the webinar, we presented a life-cycle control strategy maturity model that can identify opportunities to improve new and existing product control strategies. The model links digital maturity and control strategy maturity to enable process robustness and product quality assurance in an efficient manner. The model includes different capabilities such as development approaches, digitalization, analytics including PAT, modeling, data analytics, control regimes, and release strategies.

Control strategy maturity has been discussed by different industries and organizations but never formulated in detail in the pharmaceutical industry. With this model, we have tried to bridge the different control strategy approaches and, in particular, link the FDA control pyramid, Pharma 4.0™ digital maturity, and the use of PAT and real-time release testing (RTRT).

What Do You Enjoy about Being a Volunteer with ISPE?

ISPE has been very important in developing me professionally. I have learned a lot from my ISPE connections, particularly when I’ve been able to work with colleagues from other pharmaceutical companies. When you can collaborate and discuss with others, you learn from them. Sharing knowledge is important because you cannot learn everything you need to be successful by yourself or just by reading articles or taking courses. When you are trying to solve a problem, it really helps to hear what others have done.

For example, through ISPE I met one of the PAT pioneers within a globally operating pharmaceutical company. At that time, I was working at a smaller pharmaceutical company, and I invited him to come and talk to our production and development senior management about what his company had achieved by applying PAT. This talk was an eye-opener and my senior management gave me the go-ahead to kick off a PAT program. I became responsible for implementing PAT and quality by design (QbD).

This connection through ISPE was an amplifier for my professional career. It is all about having a good network to work and share knowledge with, and I get that through ISPE.

One of the things I try to do is to support our emerging leaders in our Communities of Practice so they can get exposure by talking at conferences, writing, and presenting to expose them to members working in similar endeavors. I try to connect them with other people.

What Do You See as the Future of the Communities of Practice?

Right now, the Communities of Practice has strong momentum. One of the Communities of Practice Steering Committee members suggested we discuss PAT modeling and data analytics using Open Source software and new digitization efforts. We are hoping to kick off some town-hall-type meetings for the Communities of Practice members at large. We would love to see more robust conversations on our forum in ISPE Engage. We really encourage members to get involved, to ask their questions, and to propose content that they want us to focus on.

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