The essence of how science and technology contribute to our industry is the creation of new knowledge, and then utilization of that knowledge to enhance human lives, and to solve the various issues facing our industry. The whole arena of science and technology deals with five fundamental components: knowledge, skills and techniques, discovery, understanding and application. It is the interplay between science and technology that leads to advances in modern society. In this session, panelist will illustrate all five fundamental components of science and technology leveraging robotics to drive flexibility while reducing human interventions, digitalization and data minding for pinpointing product handling issues, and new take on BFS as it relates to Annex 1

Novel therapy methods require new approaches and manufacturing techniques, all with their own challenges. This session will examine how to overcome some of them through various examples and case studies. We will learn how a Virtual Reality Simulator can be used to train and monitor employees on targeted behaviors to avoid previously identified critical errors, the critical steps to take during a contamination event and how accurately identify the source of contamination, as well as cleaning processes for in lipid nanoparticle (LNP) delivery systems.

This session will explore the advancements and innovations in decontamination and single-use technology to comply with the newly revised EU GMP Annex 1. New gaseous hydrogen peroxide (H2O2) with lower percentages of peroxide have been shown to lessen downtime from off gassing following treatment and have improved material compatibilities. Furthermore, the development and validation of H2O2 cycles continue to see advancements with the use of enzyme indicators. The understanding of enzyme indicators and their possibilities continues to grow as more data about the influence of temperatures, storage conditions, timing of the reading, and degree of inactivation is gathered through experimental results. Lastly, the revised EU GMP Annex 1 maintains the importance of cross-contamination prevention and operator risk. Continued research and advancements in single-use technology show the advantages single-use presents for product loss and filling accuracy.

This is your opportunity to pose your most pressing quality and regulatory questions directly to a panel of respected FDA thought leaders in the aseptic processing space. This moderated and interactive discussion continues to be a much anticipated and highly rated session for this conference and is always informative; providing insights exclusively to conference attendees.