One year after the publication of Annex 1, 24th August 2023 Annex 1 for Sterile Products is now applicable. Now, 6 months later, we would like to examine what the challenges, opportunities, and threats are in the implementation of Annex 1 for ATMPs.

ATMPs are coming to the market with specific requirements, small batches, time to time one batch per patient. How to develop production to reach patients across the world with short shelf life and which type of organisation could support this kind of product for the benefit of patients? Drawing together ATMPs, Digital Transformation Pharma 4.0, and Annex 1, the session will allow the audience to hear how Annex 1 will affect ATMPs with the support of computerised systems. We expect this to be a stimulating conversation with plenty of information. The various presentations from the industry will cross-inspect topics related to Contamination Control Strategy (CCS), including automation of robotics systems in ATMPs.

Digitalization has reached the Life Sciences Industry accelerated by the Covid 19. The essential value of data as an asset has been broadly recognized to ensure not only connectivity and supply chain but also product lifecycle management. Digitalisation with its new dimension of leveraging data to increase performance, agility, customer centricity, prevent failures, etc. will advance our Pharmaceutical Quality System towards a new dimension of Quality 4.0. The ISPE Advancing Pharmaceutical Quality (APQ) guide series together with the new ISPE Pharma 4.0 baseline guide has been developed to support the industry in stepping up and accelerating towards Quality 4.0.

In our track you can expect the following interesting topics:

• Deep dive what are the principles and value of Quality 4.0 – finally for the benefit of patients
• See how the APQ guidance can help you advance your PQS to the right maturity level for the digital transformation
• Demonstration of several use-cases applying various innovative technologies in practical life, e.g., to support the definition of a Design Space, holistic control strategies to prevent deviations, to track regulatory changes.
• Get a feel for how the new Pharma 4.0 baseline guide helps your quality transformation
• Closing by an interactive panel discussion together with regulators, experts from operations and quality about Quality 4.0, their expectations, and requirements for Quality 4.0

Annex 1 has some challenges for existing facilities that need to be adapted or retrofitted, but also for new facilities to meet the requirements. This includes things like automated lyophilizer loading and sterilization, barrier systems, monitoring systems, filtration systems, and media. On top of that, there are quality system adaptations that are needed, for example on aseptic process simulations, aka media fills. All this has to fit into the overarching principle of the contamination control strategy, CCS. In this track, we will showcase examples of implemented retrofitting projects and modifications to quality systems. This will also include examples of the use of single-use systems and concepts to introduce PUPSIT, pre-use post-sterilization integrity testing of filters. Attendees will be able to take home lessons learned from projects that they can apply in their own facilities. Potentially, there will even be reports from regulatory inspections after August 2023, when Annex 1 comes into effect.

Learn about specific Pharma 4.0™ approaches, strategies, and solutions available today and in the near future, for optimizing the production life-cycle process from suppliers through manufacturing operations and final delivery of life-saving therapies to patients. The complexity of the global life science supply chain infrastructure, along with the likelihood of future unpredictable market disruptions, requires the agility to make real-time business decisions resulting in better patient outcomes. This will require optimization through the implementation of available Industry 4.0 technologies, applied to critical applications and use cases throughout the end-to-end production process. It will also require the ability to digitally integrate with key business partners, starting from strategy and planning through final production execution. Some of the highly relevant topics that will be covered in this track will include:

• Digital Supply Chain Strategies, Roadmaps & Solutions
• Digital Manufacturing Strategies, Roadmaps & Solutions
• Digital Partner Integration Strategies, Roadmaps & Solutions

The newly released Annex 1 is already having an impact on equipment. Vendors are innovating and owners of existing equipment are pursuing modifications sometimes at the boundary of technical feasibility. With such a focus on Contamination Control Strategy (CCS) learn how advanced manufacturing setup, specifically in equipment design can ensure your CCS is more straightforward and fact-driven. Learn how the market is responding to meet the new guidance. Topics like real-time environmental monitoring, advanced automation such as Robotics, asynchronous/frictionless motion systems, the options available for material and product transfers between zones and critical equipment as well as the processes to decontaminate, sterilize and set up direct and indirect product contact parts, and the expectations around Aseptic Process Simulations (APS) will be featured. This track will provide various case studies on new innovations together with expanded discussion between the audience and presenters.

The aim is to explore the potential of “enabling technologies” for Pharma 4.0TM projects. Even though we are all aware that technologies alone are not the answer to challenges that our industry must face, they are a key element of a wider solution, inclusive of revised business and compliance processes, innovative digital solutions and equipment, and as a key enabler, new organisation and culture.

New opportunities offered by recent and emerging technologies are completely changing the game and making new scenarios possible, even the ones considered impossible a few years ago. Our goal is to deep dive into innovative, but industry proven, ways of extracting benefits from Digital Solutions that combine one or more enabling technologies, like GxP Cloud, Smart and Wearable Devices, Collaboration Platforms, Big Data and Advanced Analytics, Industrial Internet of Things (IIoT), Artificial Intelligence / Machine Learning (AI/ML), Process Mining, Natural Language Processing, Image Recognition, Advanced Modeling, Advanced Robotics, Augmented Reality (AR), Virtual Reality (VR), Additive Manufacturing, Robotic Process Automation (RPA), but also the ones less mature in our industry, such as Biometric identification, Blockchain, Speech and Gesture Recognition, Edge Computing, and Quantum Computing. Each Use Case is reporting the problem, the solution, the benefits, whenever possible quantitative, the constraints, and the lesson learned.