The EU GMP Annex 1 is an enabler for the implementation of new innovations in sterile/aseptic manufacturing. Continuous Monitoring for Contamination Control Management, rapid microbial testing, automation with robots, Digitalization, validated and automated material transfers, and containment as barriers are some of the keywords for the Pharma 4.0 transformation. Regulatory agencies, industry, and solutions/innovation providers need to collaborate to enable this transformation for the highest safety of sterile pharmaceutical manufacturing.

Advanced Therapies Medicinal Products are on an increasing curve in the pharmaceutical market. These products are essential for patients. As for some products, the starting material comes from the patient, failing a batch is not an option. How can the industry deliver safe products to patients improving their processes and Annex 1 implementation and using more data management to have faster product release? This track will consider autologous and allogeneic Cell Therapy and Gene Therapies products.

If you have practices of these operations with the support of “aseptic” processes and using digital transformation with more data generated by the process control, you are welcome to share your experience related to the following topics:

• How to avoid cross-contamination
• Closed Processes
• Benefits of digital transformation, Pharma 4.0 in this area
• How to improve contamination prevention in these products with process control, process design, and facilities design
• How to improve process understanding by using digital methods
• How to support batch release for products with a short shelf life
• Could Artificial Intelligence and/or Machine learning be beneficial for such applications

This list is not exhaustive; we are excited to receive your proposal to build a robust track around ATMPs with the support of Annex 1 and Pharma 4.0.

The Digital Business Transformation requires Business Process changes supported by enabling technologies. Implementing these technologies alone is not the right answer to the challenges that our industry must face, but they are a key element of a wider solution, inclusive of revised business and compliance processes, and innovative and sustainable digital solutions.

New opportunities offered by emerging technologies are changing the game and making new scenarios possible, even the ones considered impossible a few years ago. Our goal is to deep dive into transformation by presenting Case Studies to achieve benefits from digital solutions. These case studies are based on the enabling technologies such as Smart Wearables, Collaboration Platforms, Generative AI, Machine Learning, Advanced Robotics, Augmented Reality, and Virtual Reality, as well as less mature technologies in our industry such as Blockchain, Speech and Gesture Recognition, Edge Computing, and Quantum Computing. This track will highlight practical applications of these technologies in industry case studies, including benefits, challenges, and lessons learned.

The integration of Pharma 4.0 strategies into facility design and construction requires a forward-thinking and transformative approach to pharmaceutical manufacturing. Embracing 'plug and produce' principles presents both opportunities for an integrated and interconnected facility, as well as challenges. It necessitates agile infrastructure capable of supporting modular and flexible production systems and interconnectivity. Case studies reveal that while implementation complexity is a hurdle, the benefits of enhanced efficiency, scalability, and compliance are compelling.

We plan to organise a 2.5-hour workshop session around Annex 1 implementation and discussions about where Annex 1 makes sense for the manufacturing of ATMPs with the support of Pharma 4.0. If you have already implemented new technologies to improve aseptic processes, we encourage you to submit a workshop proposal to discuss these points with conference attendees.

We will have a short presentation to set up the scene, followed by break-out sessions that will allow participants to find ideas to make proposals around the problem statement developed during the starting presentation. The programme committee is excited to read your proposal.