AsAI-driven discovery floods the pipeline with candidates, L7 Informatics arguesthe constraint on speed to patients has moved from the lab to Chemistry,Manufacturing, and Controls, and that orchestrating the work across internallabs and external partners on one governed data model is how precision sciencescales.
AUSTIN,Texas, September 22, 2026 — Artificial intelligence is accelerating drugdiscovery faster than the systems meant to turn candidates into medicines canabsorb. According to L7 Informatics, that mismatch has exposed anew constraint on how quickly a portfolio reaches patients, and it sits inChemistry, Manufacturing, and Controls (CMC), the work that turns a researchmolecule into a reproducible, releasable product.
CMCis where timelines and cost concentrate, and it no longer happens inside onecompany's walls. A modern development program runs across dozens of externalpartners, including Contract Research Organizations, Contract Development andManufacturing Organizations, analytical laboratories, and fill-finish sites,often connected by little more than batch records re-keyed by hand,certificates of analysis sent as PDFs, and status tracked in email. AsAI-driven discovery pushes more candidates into that network, those documenthandoffs become a rate-limiting step.
Thecompany argues that adding more point tools makes the problem worse, becauseeach new system introduces another translation burden at the boundaries betweenthem and compounds integration debt. That view echoes industry analysts. In its2025 Market Guide for Laboratory InformationManagement Systems,Gartner observed that point solutions can expand laboratory capability whileadding technical debt, and pointed to unified platforms as an emergingarchitectural direction.
L7Informatics argues the industry must now shift to CMC-in-the-Loop: coordinatingthe work across R&D, Manufacturing Science and Technology, manufacturing,and external partners through a single, governed data model, so processknowledge and quality data follow each molecule from research through clinicalmanufacturing and technology transfer. Expressed in the ISA-88 and ISA-95standards used across process industries, a development recipe and a commercialmanufacturing recipe rest on the same structural foundation, which reduces thetranslation required at each partner boundary.
Theapproach also sets a standard for how AI operates in regulated work. People andAI agents work within the same governed environment, with attributableidentities, defined permissions, and a common audit framework, while agentsoperate under additional boundaries and risk-based validation appropriate totheir use. This is the foundation behind L7|ESP®, the company's agenticoperating system for precision science.
Regulatorsare moving the same way. The FDA's Knowledge-Aided Assessment and StructuredApplication program and its Pharmaceutical Quality/CMC data standards effortare shifting quality information toward structured, machine-readable formats,which favors organizations that capture quality data as structured records atthe point of execution.
"Foryears, the industry has asked how to automate the next instrument or the nextlab," said Vasu Rangadass, Ph.D., Founder and CEO of L7 Informatics."That question is useful, but it cannot address the larger problem. Thequestion that scales is how to orchestrate an entire scientific outcome acrossinternal labs and external partners under one governed model."
"AIdid not create this problem. It exposed one that was already there,"Rangadass added. "The silos and manual handoffs were tolerable whentimelines had slack. AI takes the slack away, and the missing coordinationlayer becomes the thing holding the pipeline back."
Thefull argument is available in Rangadass's article, "BeyondLab-in-the-Loop: Orchestrating CMC-in-the-Loop," at https://l7informatics.com/blog/orchestrating-cmc-in-the-loop/
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AboutL7 Informatics:
L7 Informatics delivers the foundationalsoftware infrastructure that connects data, intelligence, and operations for precisionsciences and healthcare. Its enterprise platform, L7|ESP, serves as an AgenticOperating System that unifies scientific workflows, equipment, and teams into asingle composable ecosystem.
MediaContact:
L7Informatics Communications