Comparability by design: What worked, what broke, what’s next

This workshop cuts straight to what works. Cabaletta Bio will present an implementation case study on automating rese-cel manufacturing on the Cellares Cell Shuttle™ platform, including split-apheresis runs, analytical method bridging, GMP readiness activities, and data demonstrating consistency versus historical manual performance that supported a successful IND amendment.

The session will then transition to a panel discussion and audience Q&A, moderated by Shon Green, bringing together perspectives from preclinical, clinical, and commercial-stage programs. Shon will surface the questions many early-stage developers face as they plan for scale, including what to lock in early, what to avoid, and how to build a comparability strategy that holds up through tech transfer and expansion. Panelists will include Yan Li of Cabaletta Bio, offering the clinical-stage perspective, and Cellares COO Ossama Eissa, drawing on experience commercializing two CAR T assets at Novartis and Legend Biotech in collaboration with J&J.

The discussion will focus on the decisions that matter most: when to start planning CMC and scaling, how early process improvements influence regulatory and investor expectations, and what “right-time” readiness looks like.