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Message from the Chair: Why Attend the 2023 ISPE Pharma 4.0™ & Annex 1 Conference

Jörg Zimmermann
Message from the Chair: Why Attend the 2023 ISPE Pharma 4.0™ & Annex 1 Conference

I have been active in ISPE for many, many years, but when I attended my first ISPE Pharma 4.0™ and Annex 1 Conference in Manchester back in 2019, I was surprised by how few people I knew. I realized that my network within ISPE was very much focussed on Aseptic, Manufacturing, and Quality, and not so much on Digitalization and Pharma 4.0™.

When we started planning for the previous conference in Vienna in 2022, people were still skeptical about it: will this really be worth it? Will people talk? Of course, they talked, and it was so fulfilling to see our concept work out. Connections were made, on a personal level and a professional level, and I would like to believe that the conference acted as an accelerator for many projects. Vienna was a great success, so we continue with this concept.

The preparations for the conference in Barcelona are now fully underway, and the program is shaping up nicely. We can see the connections between the topics, as Pharma 4.0™ and digitalization are more and more used in all aspects of our industry, while operations and aseptic processing do need the tools to bring them to the next level. By the time the conference comes, the latest version of Annex 1 will be in place, and we will hear implementation case studies.

Adapting production to the requirements of Annex 1 does mean hardware modifications for some operations, for example for the provision of steam-sterilization of indirect product contact parts (i.e., vibrator bowls) in isolators, but also the automation of lyophilizer-loading. Retrofit case studies will cover these technical aspects and will allow participants to take home learnings that they can apply to their jobs.

While highly automated processes are made even better, the more manual operations of ATMPs, advanced therapeutical medicinal products, or cell & gene therapy also need to improve to provide high-quality and compliant medicines to patients. This field is evolving rapidly, and by using the tools of quality risk management and contamination control strategy, we see big advancements.

Automation by using robots in processing steps previously overlooked, coupled with the availability of digital data is helping all areas of the industry, from operations to maintenance to quality. Using the data generated in an intelligent way can lead to best practices like predictive maintenance, therefore reducing time and cost.

RABS and isolators for fill-finish operations provide separation of the operators from open products and containers but need a high level of process knowledge and operator training. These days, training is being revolutionized by augmented reality and virtual reality tools. The ramp-up of new filling lines is often bottle-necked by the available time on the line to train the operators; wouldn’t it be great if most of that training could be done offline, in a virtual reality setting? Imagine if you could show the operators the effects their handling has on air flow within the barrier!

New methods like rapid microbial monitoring and testing are another field that is actively encouraged by regulators, leading to a paradigm shift. The industry needs to move away from traditional methods by building a bridge to new technologies, which give a completely different level of data quality.

The availability of data in the integration of ERP and quality systems is revolutionizing the way supply chains work. Batch-release times are cut, providing medicines to patients earlier. This also helps reduce the risk of drug shortages.

The conference in Barcelona will feature high-level, thought-provoking keynote presentations from C-suite industry executives and representatives of regulatory bodies like EMA. Parallel tracks will then provide a deep dive into the subjects of Pharma 4.0 and Aseptic Processing and Annex 1. Also featured are panel discussions that provide the possibility of questions directly from the audience.

As always, we have encouraged the local pharmaceutical industry to submit proposals for talks, and we are happy to share that there will be several local heroes presenting their projects from Catalunya and Spain. However, there will be speakers from the whole world of ISPE: from industry, from suppliers, and from regulatory bodies.

With a vibrant exhibitor area, plenty of networking breaks, and social events in the evening, the conference is going to be the place to expand your network and accelerate your projects.

There is no better way to round up the 2023 conference year than by attending the 2023 ISPE Pharma 4.0™ and Annex 1 Conference in Barcelona, Spain. I hope to see you there in person!

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