Priya Baraniak

LS, Baraniak P, Bocquet C, Cap B, Delaney C, Hlucky T, et al. Thought leadership in cellular starting material: A review of summary themes from the AABB cellular starting material forums of 2021–2024. Transfusion. 2026. Barnes https://doi.org/10.1111/trf.70278 DATA AVAILABILITY STATEMENT The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

The biopharmaceutical industry currently finds itself at a precarious intersection of unprecedented innovation and antiquated validation. We have unlocked unprecedented capabilities in gene editing and cell engineering, yet the fundamental mechanism we use to determine if a drug is safe for humans remains tethered to the past. The industry standard, animal testing, is costly, ethically fraught, and often fails to predict human biological responses.

Biology may be complex, but in 2025 the industry proved it doesn’t have to be chaotic. From manufacturing CAR-T cells inside the patient to industrializing organoid platforms, the year marked a decisive move toward precision, standardization, and access, writes Priya Baraniak. The biopharmaceutical landscape looks fundamentally different than it did just twelve months ago.