Agenda March 17, 2027: Main Conference Day One - PT (Pacific Time, GMT-08:00)
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.
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.
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.
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).