From Research To Reality: How Raw Materials, Media Composition, And Process Decisions Shape Advanced Cell Therapies

By Gonçalo Regalo, PhD, senior product manager, cell therapy

Autologous cell therapy manufacturing fails to scale when early process decisions aren't made with commercial production in mind. Serum-based media, long a standard in academic development, introduce a 'black box' of variability that makes it nearly impossible to correlate process choices with patient outcomes, a correlation regulators increasingly expect.

Moving to defined, serum-free formulations early reduces risk before it compounds. Cytokine selection matters too: IL-7 and IL-15 are gaining ground over IL-2 for greater phenotypic control, but lot-to-lot consistency of any recombinant protein is non-negotiable at scale. Platform choices carry similar consequences; preclinical work in plates and flasks won't predict behavior in stirred-tank bioreactors, and single-box solutions that feel convenient early can lock you into a platform that won't support later clinical stages.

Gonçalo Regalo, Senior Product Manager Cell Therapy, shares these and other scale-up considerations in the interview below.