Two different topics and general papers are being presented throughout four sessions.
Sustainability in Bioprocessing
Monday, August 14 from 8 am – 12 pm PST in Foothill D (hybrid)
Seeking innovations and updates in sustainable practices for bioprocessing or unique bioprocessed products that improve sustainability. Sustainability includes any practice that helps meet current needs without sacrificing needs of future generations. This includes improved use of limited natural resources as well as social and economic sustainability.
General Papers
Monday, August 14 from 10 am – 2 pm PST, virtual
In the last decade, technical advances in both upstream and downstream have led to the advent of integrated continuous biomanufacturing (ICB). Continuous manufacturing is becoming an attractive choice for process intensification of relatively stable products such as monoclonal antibodies and vaccines, in addition to the labile products for which continuous manufacturing (e.g., perfusion) has historically been used. Current ICB technologies and platforms promise to reduce manufacturing footprint, capital investment, and operational costs enabling flexible facility designs while increasing productivity and ensuring product quality consistency. This session will encompass advances in upstream perfusion and continuous processing, including advances in process development, process characterization, bioreactor engineering and cell retention devices, scale-up/scale-down model development, and cell line engineering/adaptation. Papers relevant to these topics are highly encouraged, including those focusing on process control and handling operational complexity, cell retention, ICB platform development, media development, bioreactor design, and process/facility economics.
General Papers
Monday, August 14 from 3 p m – 7 pm PST, virtual
The development and commercialization of biotherapeutics depends on successful upstream process development to identify the ideal protein candidates and its final cell line for commercial production, as well as cell culture media, bioreactor process conditions, and process control/monitoring. Enhancements in laboratory automation, DNA synthesis, and synthetic biology have led to rapid advances in the throughput and approaches taken in upstream process development. The application of technologies such as cell-free expression, microfluidics, and automated bioreactors has enabled the rapid design and testing of increasingly large numbers of protein candidates and production conditions in reasonable timelines. Advances in machine learning and other computational methods are being implemented on the multidimensional data sets generated during high-throughput upstream process development to drive process decision-making and generate cross-program learnings. This session will focus on developing and applying experimental and computational tools, workflows, and processes that increase our ability to perform therapeutic candidate development in a high-throughput, automated fashion. This session will explore advances in functional artificial intelligence-based algorithms for accurate sampling of property landscape, analytical characterization, and the rational design of biological materials and functions. Finally, this session will foster discussion on the use of community standards and initiatives to improve these processes as new ways to distribute and share data across the community.
Drug Products – Fill & Finish Featured Topics
Thursday, August 17 from 8 am – 12 pm PST in Foothill D (hybrid)
Succeeding downstream processing, drug product development involves several key areas to support commercialization of products: i. Formulation development: high-throughput screening strategies, formulation impact on modality stability; ii. Development of analytical techniques to evaluate modality quality from processing stresses; iii. Process characterization: freezing & thawing, mixing/dilution, bioburden & sterile filtration, filling techniques, container closures, packaging innovations; iv. Studies focused on simulating clinical stresses: IV bags, material compatibility, light sensitivity, temperature exposure, transportation stress; v. Strategies for accelerating drug product development processes to support accelerated timelines. Please join us in putting the spotlight on this critical part of drug production. We invite presentations relevant to any of these important topics.