News
Foxborough, Massachusetts — October 6, 2026 — Stellix announced it is a founding member of the Digital CMC Consortium, a pre-competitive, 501(c)(6) nonprofit industry collaboration formed to modernize Chemistry, Manufacturing and Controls (CMC) across the life sciences industry. The announcement coincides with the Consortium’s public launch, which brings together eight founding organizations spanning pharmaceutical development, contract manufacturing, industrial automation, software, and consulting: Novartis, Pioneering Medicines, QbDVision, Rockwell Automation, Stellix, Takeda, Thermo Fisher Scientific, and ZS Associates.
CMC today still runs largely on static documents. Process knowledge is captured in reports that fragment across departments and systems, so every technology transfer between sites, or between a sponsor and a contract development and manufacturing organization (CDMO), begins by rebuilding an understanding that already exists elsewhere, a process that can routinely take six to 18 months. As discovery and clinical development accelerate, and as regulators including the FDA, EMA and PMDA move toward structured, machine-readable submissions, that gap has become a critical-path risk for the industry.
The Digital CMC Consortium addresses this by standardizing the business processes, knowledge, and the data models organizations need to share, without prescribing the underlying science, technology, or any single company’s way of working. Working in a pre-competitive format, member organizations share the cost, effort, and risk of building a common business process layer and a machine-readable data layer, so that process knowledge can move between companies and systems without being rebuilt each time. As a founding member, Stellix is contributing people, process knowledge, and working time toward the Consortium’s current workstreams, including technology-transfer business standardization, a lifecycle framework spanning research through commercial manufacturing, and alignment with existing standards bodies such as PDA, Pistoia Alliance, ISO, Allotrope, and ICH.
“Stellix’s role in this industry has always been to connect strategy, systems, and people so that progress in one part of an organization doesn’t stall at its edges,” said Tim Adkins, Secretary and Treasurer of the Digital CMC Consortium, representing Stellix. “The same is true across organizations. No single company can standardize an industry on its own, and no customer benefits when knowledge has to be rebuilt every time it crosses a boundary. Joining the Consortium as a founding member reflects our ecosystem approach: working alongside biopharma sponsors, CDMOs, technology providers, and regulators to build shared foundations, because that is what ultimately delivers better outcomes for our customers and, further down the chain, for the patients they serve.”
Stellix will continue to work alongside its fellow founding members and the Consortium’s Board of Directors as the organization publishes its outputs for industry-wide adoption.
About the Digital CMC Consortium
The Digital CMC Consortium is a pre-competitive not-for-profit industry collaboration organized around a singular goal: the end-to-end digitalization of Chemistry, Manufacturing, and Controls (CMC). The Consortium unites biopharmaceutical organizations, CDMOs, consulting firms, and technology innovators to establish open digital standards across drug development and manufacturing, laying the foundation for the AI era in CMC. Upgrading this legacy infrastructure removes a major bottleneck, accelerating the delivery of life-saving therapies to patients who need them urgently. Learn more at digitalcmc.org or https://www.linkedin.com/company/digital-cmc-consortium.
About Stellix
Stellix closes the gap between digital vision and real-world execution, helping organizations in the life sciences and other critical industries build adaptive operating models and digital foundations for AI-enabled operations. We stay accountable for achieving our customers’ desired outcomes over time, so innovation compounds into sustained operational advantage. Through the one-of-a-kind Stellix Experience Center and Future Lab, customers can see, test, and benchmark how connected systems and adaptive operating models perform under real-world conditions before scaling into production.
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