Advanced Biomanufacturing

Digital Transformation in Biomanufacturing

Biopharmaceutical manufacturing has recently vigorously embraced digital transformation to maximize productivity and efficiency. Compared to mature platforms such as synthetic medicine manufacturing, complex biological systems present both challenges and opportunities in the digital world. In particular, the breakthrough and unprecedented investment in artificial intelligence enables revolutionary interconnectivity within bioprocess systems. The collective impact of industrial-scale digitalization is profound and far-reaching. This session is intended to capture the current progress and future vision in digitalizing the next generation of biomanufacturing. We welcome topics covering advanced bioprocess modeling and monitoring, novel sensors and equipment automation, digital twin and digital control strategy, big data analytics and real-time decision-making, smart operation systems, and digital infrastructures (both software and hardware). We especially encourage insightful discussion regarding how ongoing research in AI and machine learning can evolve biomanufacturing. In addition, we look for examples of digital tech transfer, smart validation, and quality compliance, AI documentation (e.g. ChatGPT), and other digital components for manufacturing support.

Case Studies: Innovations in drug substance, drug product and device manufacturing

This session will focus on discussions of innovative approaches to biomanufacturing that are implementation-ready or being implemented into GMP manufacturing. The implementation of new technologies often involves overcoming challenges in the scalability, compliance and audit trail considerations, and stakeholder buy-in into the risk-benefit analysis. The case studies presented in this session will combine the technology development aspect with topics of facility fit, regulatory considerations, and tech transfer. The presentations will describe the steps towards implementation of the technology in GMP manufacturing and lessons learned from the project. The discussion will cover current technology gaps in manufacturing and opportunities for new technology introductions and solutions developed or co-developed with bioprocess vendors.

Novel Approaches in Tech Transfer, Scaleup, Process Analytical Technologies (PAT), and Intensified Manufacturing

The ever-changing landscape of the biopharmaceutical industry creates new opportunities and challenges in downstream processing. As a result, many organizations are exploring unique approaches to improve productivity, increase the probability of success in manufacturing, and overcome difficult tech transfers. With these drivers, this session will explore advances in process transfer, scaling of unit operations, intensified manufacturing, and Process Analytical Technology (PAT). We welcome abstracts related to the use of fundamental or engineering models to scale unit operations, digital workflows in process transfer and monitoring, and novel approaches for ensuring process-facility fit. Submissions on bioprocess intensification in the form of continuous, semi-continuous, hybrid or any other level of integrated processing are also encouraged, especially those focusing on closed systems. Finally, we hope to explore new developments in the field of PAT with an emphasis on GMP implementation, real-time control, and associated regulatory challenges. Throughout the topics of this session, case studies and the manufacturing application of novel approaches are of particular interest and will be prioritized in selection.