The three-day event, organized by at.las, is designed to provide these students with hands-on training in Good Manufacturing Practices (GMP), ensuring they understand the stringent quality standards required to guarantee the safety and effectiveness of cutting-edge medicines like cell and gene therapies. 

eyetec is proud to be a partner for this event, where Nele Van Crombrugge, one of our expert trainers, will deliver key sessions on GMP and sterile production. With her extensive experience, Nele will help students gain a deep understanding of how Good Manufacturing Practices practices have evolved and how they are applied in today’s pharmaceutical environment to ensure patient safety.

A journey through the history of GMP 

On the first day of the Summer School, Nele will provide students with a detailed look at the history of Good Manufacturing Practices (GMP), exploring the evolution of these practices from early challenges and tragedies to modern-day regulations. As Nele explains, “We’ll explore everything from the early days of medicine to the tragic story of a horse named Jim, whose contaminated antitoxin in 1901 led to the deaths of 13 children. This incident, together with other tragedies, spurred the creation of modern Good Manufacturing Practices (GMP) to ensure the safety of medicines. Understanding these pivotal moments in history gives students a deeper appreciation of why GMP is critical in today’s pharmaceutical industry.” 

This deep dive into GMP history will give students valuable context for understanding why Good Manufacturing Practices standards are vital to ensuring quality in every step of pharmaceutical production. 

Key aspects of GMP in sterile production 

In addition to the history of GMP, Nele will lead a session on the critical aspects of Good Manufacturing Practices in sterile production, with a particular focus on ATMP manufacturing. Instead of emphasizing memorization, Nele will teach students how to navigate GMP regulations and find the information they need to apply these practices effectively in real-world settings. 

Nele emphasizes: “The key takeaway for students isn’t to know everything by heart. What’s more important is that they understand how to navigate the Good Manufacturing Practices regulations and find the answers they need when they’re working in a GMP environment. It’s about being resourceful and knowledgeable, not just memorizing facts.” 

What students can expect 

Over the course of three days, students will participate in a mix of theory and practical exercises, all centered on Good Manufacturing Practices (GMP). They will gain hands-on experience applying GMP standards in real-world scenarios, covering topics such as: 

  • Aseptic process simulation & quality control 

  • Good Documentation Practice (GDocP) 

  • Material transfer and gowning in cleanroom environments 

  • Full ATMP production processes, including mRNA manufacturing 

Each session is designed to ensure students build a strong foundation in GMP and ATMP, preparing them to succeed in this highly regulated field of advanced therapies. 

Partners involved 

eyetec is proud to collaborate with Advipro, anicells, eTheRNA, MyCellHub, TRU Cleanroom Cleaning, and ViTalent, alongside at.las, the organizer of the event. Each partner brings unique expertise to ensure students receive comprehensive training in Good Manufacturing Practices (GMP), empowering them to meet the high standards required in pharmaceutical production. 

eyetec and our partners are eager to continue shaping the future of Good Manufacturing Process professionals. The skills students gain from this experience will not only benefit their careers but also contribute to the progress of the pharmaceutical industry as a whole. 

🎥 Relive the GMP Summer School 2023! 

Before we look ahead to this year’s event, take a moment to watch the aftermovie from GMP Summer School 2023. This video captures the hands-on learning, expert insights, and excitement of last year’s program.