The Virtual IoT Manufacturing System (VIMS) project aims to develop and industrialize a new, complete and integrated digital ecosystem (VIMS system/platform) for industrial and manufacturing environments. The core of the VIMS system combines an IIoT (Industrial Internet of Things) platform, along with all its data collected from the factories, advanced analysis techniques and Artificial Intelligence (AI) models with a Digital Twin (DT) of the factory or production line. Two use cases in the pharmaceutical sector out of this project are presented here. The first use case assesses the application of predictive calibration of the clean room environmental monitoring sensors (temperature, humidity and differential pressure) with the potential to change from periodic to condition-based calibration. The second use case is based on an application the planning team can use as a support tool for the production planning in order to get optimum options for the production batch scheduling.

Problem: Over-engineering costs a lot; however not meeting regulatory requirements costs much more. Target: To design a facility for biopharmaceutical HPAPIs that is: 1- Effective and comply with US & EU GMP and EHS regulations. 2- Efficient saving in both CapEx & OpEx. Methodology: 1- User requirements specifications. 2- Obtain BSLs for cell lines will be used. 3- Obtain and analyze products' toxicological data to estimate OEL & PDE. 4- Analyze process steps. 5- Conduct process closure analysis. 6- Apply quality risk management tools, eg: FMEA to assess different risks at different process steps. 7- Decide technical & procedural controls that are capable to reduce risks to an acceptable limit. 8- Cross check against EHS risk assessment to ensure that they are also controlled. 9- Decide primary and secondary containment measures based on risk assessment. 10- Reflect these controls on facility design & equipment URSs. 11- Verify suitability of chosen controls by quantitative risk assessment measuring carry over on equipment and residues in & outside production areas.

In this session, attendees will learn how modern IT Infrastructure Management practices and technologies can be effectively utilised to maintain IT Infrastructure in a state of continuous compliance. Utilising industry Good IT practices, service management tools and automation enables organisations to effectively manage their IT infrastructure more effectively than with traditional IT Qualification approaches.

mRNA is not just the basis of new COVID-19 vaccines. mRNA is also a versatile technology for the development and manufacturing of new medicinal product candidates such as cancer. As cancer is also a global health threat, BioNTech aspires to develop individualized cancer treatments. The manufacturing process behind mRNA-based cancer vaccine candidates is equivalent to mRNA-based the company’s COVID-19 vaccine. The vaccine manufacturing approaches mainly differs in the required quantity, e.g. a few microgram of mRNA for the individualized vaccine candidates compared to hundreds of kilograms for a pandemic supply. The new technology allowed not only developing a new COVID-19 vaccine in a record time but also to quickly ramp-up the manufacturing facilities to supply billions of doses. The presentation will reveal key elements that make mRNA such a powerful technology and that define the facility set-up of tomorrow already today, for both: individualized medicines as well as for large volume medical products such as vaccines against infectious diseases.

Following shortages of certified face masks typically used in the healthcare sector, innovative ways have emerged to combat the issue during the COVID-19 pandemic. These include increasing production from the original manufacturing sites, commissioning new production facilities locally, decontaminating single-use face masks for reuse, and developing reusable mask alternatives that meet health and safety requirements (EN14683:2019 and EN149:2001). This work presents a cradle-to-grave Life Cycle Assessment (LCA) study that compares selected mask-use options available for the UK healthcare settings. The analysis demonstrates that (1) the reuse options are environmentally preferential to the traditional "use then dispose" approach for surgical and respirator masks; (2) which reuse option has an overall environmental advantage is dependent on the actual lifespan of the masks; (3) both the manufacturing location and the material composition of the masks significantly affect the environmental performance of each mask use option, in particular for single-use alternatives.

This case study is a tutored project whose objective is to create a fictitious pharmaceutical laboratory and market a product, also fictitious. During this year 2021/2022, our group of 60 students has decided to focus on the strong potential of mRNA as a treatment for cystic fibrosis. We attend to this conference to present 2 aspects : how we developed our medication, Muscidarn, and the way to produce it.

There are so many promises of the 4.0 world. Why has the adoption in the pharmaceutical industry been so slow relative to other industries? Is it regulations? Is it processes? Is it mindset? This session is intended to dive into some aspects related to quality and, in particular, validation. We will explore efficient, more focused ways to approach validation in a world where digital is the focus and data is fundamental. How can we demonstrate fitness for intended use in this data driven world?