Worth Reading: Q4 2025 — Biomanufacturing, Organoids, and the ALS Landscape
Five papers and one report that shaped our thinking this quarter — on closed-loop bioreactor control, vascularized organoids, and what the Answer ALS dataset is finally starting to reveal.
Papers and reports that shaped our thinking this quarter.
Closed-loop control of stem cell bioprocesses using machine learning — The most technically rigorous implementation of ML-driven bioreactor control we've seen. The approach to embedding real-time Raman spectroscopy as a process analytical technology input is directly applicable to our iPSC manufacturing workflows.
Vascularization strategies for thick tissue constructs: a comparative analysis — A useful synthesis of the field's current approaches to the pre-vascularization problem. Confirms our intuition that the microgel-based iEC approach is among the most scalable options.
Answer ALS: Multi-omic analysis of 1,000 patient iPSC-derived motor neurons — Disclosure: our lab contributed significantly to this biorepository. The scale of the dataset is starting to yield reproducible biological signatures that smaller studies couldn't detect. The mitochondrial biology story in particular is compelling.
FDA guidance on potency assays for allogeneic cell therapies — Not a paper, but essential reading for anyone building a GMP cell therapy program. The agency's thinking on functional release assays has evolved meaningfully.
Organoid intelligence: biocomputing with living neural constructs — Further out from our core work, but the questions it raises about what constitutes a regulatory boundary in living tissue models will matter for NAMs programs sooner than most expect.
Views expressed in this post are solely those of Dhruv Sareen in his personal and academic capacity and do not reflect the positions of any affiliated institution or organization. Full disclaimer
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