AUSTIN, Texas — February 23, 2026 — Cell therapy programs are not failing because of bad science. They are failing because context does not travel. That is the central argument from Kevin McMahon, a cell therapy manufacturing and CMC specialist at L7 Informatics, who contends that the industry's reliance on fragmented digital systems is creating compounding risk at every phase boundary, site transfer, and regulatory checkpoint.
McMahon argues that the consequences are predictable and preventable: delayed tech transfers, comparability studies that drag on far longer than they should, batch investigations that consume weeks rather than days, and CMC records that must be manually reconstructed before every submission and inspection. The root cause, he says, is not a lack of data. It is a lack of continuity.
"CMC is not paperwork, and it is not a gate you face at the end of development," said McMahon. "It is the backbone that makes a therapy repeatable, defensible, and commercially viable. The organizations that treat it as foundational infrastructure from day one are the ones that scale. The ones that treat it as a downstream burden face exactly that: delays, cost, and rework."
At the heart of McMahon's argument is the role of ontologies in solving what he calls the continuity problem. Formal, structured vocabularies that enforce consistent, machine-readable definitions across systems, sites, and teams, ontologies allow process context to travel with the data rather than being lost at system boundaries. Instead of each platform using its own terminology for the same concepts, an ontology ensures that a reagent, a process step, or a critical quality attribute means the same thing everywhere it appears across the product lifecycle.
McMahon also highlights KASA (Knowledge-aided Assessment and Structured Application) as a process modeling framework that structures knowledge for regulatory utility from the beginning of development. When processes are defined using structured, machine-readable terminology that captures not just what is done, but why, under what conditions, with what materials, and governed by what criteria, the byproducts are significant. Stability data becomes better controlled and searchable. Continuous Process Verification moves from a periodic retrospective exercise to a genuine ongoing capability. Tech transfers accelerate because receiving sites inherit a structured model rather than a narrative document to reinterpret.
"Imagine a world where your CMC backbone is not something you assemble before a regulatory submission," McMahon said. "It exists continuously as a living record of your program. You can pull a complete picture of your product and process history at the push of a button. Context is not lost at phase boundaries, not reconstructed during site transfers, not manually compiled before an inspection. That is not a fantasy. It is the outcome of building the right digital foundation from the start."
McMahon connects this foundation directly to AI readiness, arguing that data volume alone does not create value in regulated environments. Useful AI in cell therapy depends on whether data is connected to its meaning: which process version produced a result, which materials and lots were used, what conditions were in effect, and what decisions and approvals shaped the outcome. Without that context, AI is forced to operate on incomplete information. With it, AI can move from pattern detection to governed decision support.
L7 Informatics provides L7|ESP (Enterprise Science Platform), a unified digital platform designed to serve as this execution layer, enabling cell therapy organizations to carry process definitions, data standards, lineage, and governance from R&D through CMC and commercial manufacturing. Read the full article here: https://l7informatics.com/blog/cell-therapy-digital-continuity-r-and-d-cmc-manufacturing/
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About L7 Informatics
Founded in 2012 and headquartered in Austin, TX, L7 Informatics is redefining
digital transformation in life sciences with L7|ESP®, the execution layer that
unifies workflow orchestration and contextualized data across lab and
manufacturing. It enables organizations to flawlessly move from AI-ready
foundations to AI-actionable operations across R&D, CMC, manufacturing, QC,
diagnostics, and clinical environments. L7|ESP connects the dots between
disparate instruments, software, and teams by providing a single digital
scientific platform with flexible data modeling, extensive API integrations to
fit seamlessly into any ecosystem, and a full suite of built-in applications,
including LIMS, ELN, MES, Inventory, and Scheduling. For more information,
visit L7INFORMATICS.com.
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Jessica Tobey
L7 Informatics
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