The initiative will develop digital standards for technology transfer, knowledge sharing and AI-enabled tools across the drug development lifecycle.
Rockwell Automation, Inc. announced it is a founding member of the Digital CMC Consortium, a not-for-profit, pre-competitive industry collaboration focused on advancing digital standards and infrastructure to accelerate drug development.
Pharmaceutical companies face growing pressure to accelerate development timelines and manage rising costs while meeting complex regulatory requirements. Yet Chemistry, Manufacturing and Controls (CMC) activities, which define how a drug is developed, manufactured, tested and controlled to ensure quality, remain a longstanding bottleneck in drug development due to manual, document-based workflows and a lack of process standardization. As therapies become more complex and personalized, CMC activities must evolve into structured, digital systems that accelerate technology transfer and enable seamless knowledge sharing and data-driven decision-making.
The Consortium brings together industry leaders across the CMC ecosystem — pharmaceutical organizations, biotechnology firms, contract development and manufacturing organizations (CDMOs), technology providers and consulting experts — to address these shared challenges through a coordinated, outcomes-focused approach. Founded by visionary leaders from companies such as Rockwell Automation, Novartis, Thermo Fisher Scientific, Takeda, Flagship’s Pioneering Medicines, Stellix, ZS Associates and QbDVision, the Consortium harnesses collective expertise to solve industry-wide challenges no organization could tackle independently.
Following its first year of collaboration and proof-of-concept work, the Consortium is advancing toward broader industry adoption. Its immediate focus includes digital technology transfer and structured knowledge exchange between sponsors and CDMOs. Longer term, the Consortium aims to connect digital capabilities across the full CMC lifecycle, including knowledge management, automated content authoring, digital twins and artificial intelligence.
For more information, visit digitalcmc.org.
