Agenda March 17, 2027: Main Conference Day One - PT (Pacific Time, GMT-08:00)
This session will explore how teams are organizing screening data, historical knowledge, metadata, and analytics, including emerging bioprocessing ontology standards, so that prior work becomes more reusable and decisions become faster. It should remain practical and tied to day-to-day development impact.
Upstream development sessions must move beyond simple productivity stories and focus on the real levers that improve robustness and reproducibility. This session will explore media optimization, feed strategy, metabolism control, and nutrient management approaches that translate across scales and stages. It should emphasize practical gains in process performance and quality.
The harvest step is one of the most persistent DSP bottlenecks, especially as upstream intensification drives higher cell mass and density. This session will focus on clarification, solids management, centrifugation, depth filtration, and hybrid harvest strategies that can keep pace with upstream gains.
This session will focus on how organizations compress early timelines while preserving credible paths to scale, comparability, and approval. It will frame content around strategic outcomes like accelerating to first-in-human rather than around functions alone.
Cell therapy still often looks and feels more like a research workflow than a scalable bioprocess. This session will focus on bioreactor choices, surface-dependent growth strategies, cell expansion formats, harvest operations, and practical steps toward more industrialized manufacturing.
As biologics become more complex, host and vector engineering decisions are becoming more central to development speed and commercial success. This session will explore how teams are engineering cell lines to improve productivity, reduce product-quality liabilities, and better support expression of challenging molecules, including antibody-drug conjugates, radioconjugates, and multispecific formats that are seeing renewed industry investment. Talks should emphasize practical lessons and downstream impact.
This session will explore practical uses of AI, modeling, and automated analytics in process optimization, experimental design, monitoring, and process understanding. Talks should emphasize measurable value, not hype.
As more complex molecules move through pipelines, downstream teams are being pushed beyond standard mAb purification templates. This session will explore capture, polishing, impurity management, and platform evolution for multispecifics, fusion proteins, and ADC-related biologics, including the purification and drug-to-antibody ratio (DAR) control challenges created by newer, more stable linker chemistries.
Development speed increasingly depends on how intelligently organizations use platform knowledge, early manufacturability screening, and parallel workstreams. This session will focus on practical strategies for reducing experimental burden and shortening decision cycles without undermining scientific understanding, including how sponsors are responding to faster-iterating early-phase competitors who can generate clinical signal and move to follow-on studies more quickly. Tools to capturing and traferring platform knoweldge will be discussed.
Raw materials are one of the most consistent pain points for cell therapy. This session will examine material qualification, vendor variability, comparability between research and GMP-grade inputs, and how teams define phase-appropriate GMP in practice.
This session will focus on how organizations are redesigning CLD workflows to move faster with fewer experiments, fewer handoffs, and smarter use of prior knowledge. It should be especially relevant to senior leaders managing large portfolios.
A major advisor pain point was the lag in getting actionable product-quality data back during development. This session will focus on PAT, at-line analytics, autosampling, soft sensors, and integrated monitoring strategies that bring product-quality insight closer to real time. This shall aloinclude feedback control strategies, optimally using multi input and multipel output controllers. It should also tackle the evolving definition of PAT in biologics manufacturing.
This session will focus on where mechanistic modeling, digital twins, structured data, and smarter analytics are genuinely improving downstream development speed, process understanding, and lifecycle planning, and will hold speakers to a concrete standard: a named CQA, decision, or timeline outcome the model actually changed, not a proof-of-concept without a defined problem. A projection to Annex22 is included, in order to allow smooth validation strategies of thoe models and digital twins.
This session looks at what transfer-ready process and documentation packages look like when built in from the start, how tools like gap-assessment automation and digital batch records (the "one-click transfer" vision) are compressing traditional timelines, and why trust and communication between sites still decide success as much as the technical package does.
Gene therapy remains highly relevant when the content stays grounded in real process and economic challenges. This session will focus on vector production, purification, full-to-empty control, process consistency, and where cost and scalability are improving.
This session explores how teams are linking cell line selection, expression behavior, and early analytical data to downstream CQAs, manufacturability, and scale-up risk. It should bridge CLD, analytics, and CMC strategy.
This forward-looking panel will separate meaningful next steps from hype. This panel will focus on the technologies and workflow changes most likely to materially change CLD over the next five years, including automation, richer analytics, predictive tools, and better data integration. The emphasis should be on practicality and adoption.
Scale-up readiness is often shaped as much by internal trust and burden of proof as by technical readiness. This session will examine scale-down models, pilot-scale decision frameworks, readiness assessments, and process packages that improve transferability and organizational confidence.
As pipelines diversify, upstream teams are rethinking how far standard platforms can stretch. This panel will explore where platform upstream still creates major speed and efficiency benefits, where it introduces hidden constraints, and how teams decide when to customize. It is a strong bridge between technical work and strategic portfolio decisions.
High-concentration processing is both a technical and commercial priority, especially as more products move toward subcutaneous delivery. This session will address UF/DF limits, viscosity, membrane constraints, and concentration strategy, and will extend deliberately across the drug substance/drug product boundary — covering high-concentration formulation development, device and auto-injector readiness, and the handoff requirements between DS and DP teams that advisors identified as a consistently underserved topic at prior events.
Throughput and cost of goods came up repeatedly as core DSP concerns. This panel will focus on the tradeoffs between resin strategy, batch sizing, facility fit, cycle time, process complexity, and total cost, including the cases where sustainability goals and cost reduction now point the same direction (and the cases where they don't).
The most useful manufacturing strategy themes fit naturally here when applied to execution speed. This session will focus on digital batch records, documentation workflows, data integration, AI-assisted report generation, and knowledge retrieval approaches that reduce friction in CMC, transfer, and filings.
Technical and non-technical causes of delay: GMP slot shortages, assay failures, process surprises, transfer friction, short stability windows, comparability hurdles, documentation burden, data governance, defintion of holistic control strategies, and organizational silos. This panel will help prioritize the most avoidable sources of delay.
This session should focus on machine learning, image-based analytics, process prediction, data governance, and digital coordination tools that support complex, variable, and patient-linked products.