Agenda March 16, 2027: Pre-Conference Day - PT (Pacific Time, GMT-08:00)
Tech transfer has re-emerged as one of the most persistent bottlenecks in bioprocess development and manufacturing. Whether teams are transferring internally, moving programs across global networks, onboarding new partners, or shifting supply chains in response to geopolitical and onshoring pressures, the process remains too slow, too manual, and too vulnerable to rework. Comparability requirements, documentation gaps, site-fit issues, and misalignment between sending and receiving teams continue to add risk and delay.
This half-day workshop will bring together development, MSAT, CMC, and manufacturing leaders to explore how companies are improving transfer readiness, reducing friction, and building more effective handoffs across sites and organizations. Through practical presentations and case studies, attendees will learn what strong transfer packages look like, how leading teams approach comparability and readiness by phase, and where digital tools can make transfer faster and more reliable.
Facing tighter capital budgets and mounting pressure to bring manufacturing online faster, the industry has adopted process intensification as its primary lever for extracting more output from existing equipment and footprint. It's best understood as a toolkit, not a single technology, and continuous processing is one of its most powerful tools, not the whole story.
This half-day workshop takes a technique-agnostic look at what's actually delivering results today: intensified fed-batch, high-density N-1 perfusion seed trains, continuous and multi-column chromatography, fully connected end-to-end processing, and the PAT and digital control systems that make all of it possible. Attendees will hear real case studies on where continuous processing has paid off, where a simpler intensification approach got the job done just as well, and how leading organizations are deciding which tool fits which problem - grounded in deployed, real-world implementations rather than aspirational roadmaps.
Organizations across bioprocess development and manufacturing are under pressure to act, but many are still wrestling with the same questions: Which use cases are actually delivering value? Why do so many digital initiatives stall? What data infrastructure is required before AI can work at scale? And how can companies move forward without investing in tools that become obsolete before they are fully deployed?
This half-day workshop will focus on practical, presentation-based examples of where AI and digital workflows are improving productivity, reducing documentation burden, enhancing process understanding, and enabling faster decisions. It will also address the less glamorous but essential foundations of digital transformation, including data access, standards, governance, and workflow integration across development and manufacturing environments. As tools mature, the workshop will also address the workforce side of this shift: how organizations are upskilling staff, retaining institutional knowledge from an aging workforce nearing retirement, and building "human-in-the-loop" workflows rather than simply automating around people.
Every track in this program is built around the same underlying tension: organizations are under real pressure to move faster, from early cell line and process development through scale-up, technology transfer, and commercial manufacturing, but speed that outruns risk management and quality creates rework, delay, and cost that erase any time gained. This opening plenary will set the frame for the rest of the conference by examining how leading organizations decide what genuinely needs to be locked down early versus what can safely be resolved later, how phase-appropriate control strategies are defined and defended internally, and what it actually means to build quality and risk management into a development program rather than layering it on at the end. Speakers will address the organizational, technical, and regulatory dimensions of this balance, and set up the practical, track-level conversations about acceleration, comparability, and manufacturability that follow over the next two and a half days.