Bioprocessing 4.0

Five topics will be presented throughout five sessions.

Breakthrough Technologies for Continuous Manufacturing: Case Studies in Steady-State Manufacturing

Monday, August 14 from 2 – 6 pm PST in Foothill D (hybrid)

This session invites speakers to share case studies of the challenges and successes of integrated process design to enable second generations of processes and steady-state manufacturing processes. Whether designing for a new product introduction or a revamped process design, many factors need to be considered for system selection, facility fit, and optimization from traditional batch to steady-state manufacturing processing. These may include leveraging fundamental/engineering models to anticipate or bridge to current predict large-scale performance or novel approaches for process characterization. We seek abstracts that cover the broad range of development activities, focusing on the successes and challenges of fully integrated upstream & downstream processes for integrated processes designs for second-generation processes as well as case studies directly comparing batch, continuous, and/or hybrid modes (e.g. analysis of production cost and time). Submissions covering experiences and lessons learned from second-generation processes are also welcome.

Integrated Bioprocess Development: Case Studies in Integrated Process Design, Process Intensification, and Tech Transfers

Tuesday, August 15 from 8 am – 12 p PST in Foothill D (hybrid)

In the field of next generation manufacturing and interconnected bioprocessing, more companies are willing to adopt novel approaches. Due to many factors, each company finds themselves at a different stage of generating a viable system whether they are beginning to design an integrated process, understanding the technical issues that come with scale up/scale down, or advanced enough to undertake facility fit and tech transfer challenges. Assuring successful implementation in a facility can require new approaches to gain additional insight into scaling, simulation, and/or modeling. These may include fundamental/engineering models used to anticipate large-scale performance, as well as development of appropriate small-scale models used for process characterization and/or troubleshooting. We seek abstracts that cover this broad range of development milestones which starts with companies seeking to take initial steps into interconnected bioprocessing with case studies focusing on pilot scale proof of concept systems. For more maturely developed systems, we seek scale-up and scale-down and tech transfer topics, particularly for cases where challenges related to scaling and single or multi-facility fit were observed, and novel solutions or technologies were required.

Applying High-Throughput Approaches from Discovery Through Launch

Tuesday, August 15 from 2 – 6 pm PST in Foothill D (hybrid)

The evolving healthcare landscape, from the emergence of novel pandemics (e.g. COVID-19) to the growth of cell and gene therapies, has challenged traditional paradigms of biopharmaceutical discovery and development. Increased emphasis on resource efficiency and speed to market, challenges with recruiting and retaining a technically skilled workforce, and increased commercial drivers to reduce the cost of goods all provide pressure on both R&D and commercialization organizations to discover innovative therapeutics, and develop, characterize, and deploy right-first-time processes in record time with minimized resources. This session will focus on advances in high-throughput (HT) technologies and lab automation that accelerate and improve the robustness of biotherapeutic discovery, development, characterization, and launch. Advances in microfluidic technologies, automation, artificial intelligence, robotics, synthetic biology, and fundamental chemistry are front and center of these efforts. We are interested both in talks covering specific novel approaches, as well as case studies illustrating the application of these approaches along with associated challenges, risks, and lessons learned.

Digitization in Bioprocessing and Machine Learning

Wednesday, August 16 from 8 am – 12 pm PST in Foothill E (hybrid)

This session will focus on technologies and approaches that will enable next-generation manufacturing of biopharmaceuticals, including recent scientific advancements, showstoppers, and potential of the smart manufacturing tools. Topics that are pertinent to this session include digital twins of biopharmaceutical unit operations and processes, mechanistic modeling, real-time process monitoring, statistical process control, model-based control, and risk assessment. Case studies that illustrate the application of these concepts towards facilitating consistency in process and product quality attributes, enhanced productivity, reduced cost of manufacturing, and implementation of PAT would be of particular interest. We are looking for a mixture of talks focusing on the development of enabling technologies and case studies on analytics, automation, and control. Talks could also potentially cover hybrid modeling solutions that combine mechanistic and data-driven approaches, and other industry 4.0 concepts. Any constraints or challenges relating to technology implementation, regulatory considerations, and the subsequent impact on the widespread adoption may also be presented.

Breakthrough Technologies for Continuous Manufacturing

Session II: Wednesday, August 16 from 2 – 6 pm PST in Foothill E (hybrid)

It is a very exciting and dynamic time in the field of continuous bioprocessing. Over the past decade, incredible breakthroughs and advancements have made continuous biomanufacturing not just a possibility, but a reality. We are witnessing fully integrated continuous bioprocesses enter commercial readiness and implementation while at the same time pushing the boundaries of productivity. However, most conversations to date have focused on the conversion of “traditional” batch unit operations into continuous versions of the same operation for proteins. This session will focus on disruptive innovations in process technology that are enabled by continuous processing, beyond the current state of the art. How can we further intensify biologics production? Is the future still CHO? What types of separations can be performed with ICB that aren’t feasible in batch mode? How can we make biologics manufacturing more sustainable? We invite submissions that push the boundaries of innovation such as chromatography-free routes to continuous bioprocessing, the developments of novel continuous unit operations required for further process intensification, and the scientific approaches to address sustainability challenges. Application of strategies for manufacturing emerging modalities employing the concepts of continuous flow and integrated unit operation control strategies are also of interest — including exosomes/extracellular vesicles, viruses, viral vectors, virus-like particles, cells, plasmids, and nucleic acids.