A new industry consortium is aiming to overhaul one of pharma’s most persistent digital bottlenecks: Chemistry, Manufacturing, and Controls (CMC).

 

The Digital CMC Consortium launched as a pre-competitive collaboration bringing together biopharmaceutical companies, biotech firms, CDMOs, technology providers, and consulting organizations to drive the end-to-end digitalization of CMC.

 

The group was founded by leaders from Novartis, Thermo Fisher Scientific, Takeda, Flagship's Pioneering Medicines, Stellix, ZS Associates, QbDVision, and other industry organizations. Its goal is to transform traditionally static CMC knowledge into reusable, interoperable digital assets that can improve development speed, quality, and operational and regulatory confidence.

 

The Consortium is combining existing industry guidelines with new standards designed to address gaps that have slowed digital adoption. It is also developing the tools and code needed to turn those standards into practical, digital-first workflows that companies can implement immediately.

 

“The pharmaceutical industry has already been successful in digitizing discovery and clinical trial workflows. Now we have the opportunity to bring that same level of transformation to CMC," said Consortium Chairman, and Chief Business Officer with QbDVision, Mike Stapleton. 

 

“Global supply chains and modern regulatory frameworks have grown increasingly complex. By uniting, we can solve the interoperability challenge and build the structured, contextualized data foundation required for AI: ultimately, we will enable businesses to work together in the seamless, digital ways we expect in our everyday lives.”

 

While pharmaceutical science continues to advance, CMC operations remain heavily reliant on manual, document-based processes, with PDF tables often treated as the source of truth. The Consortium argues that replacing this legacy infrastructure with structured, interoperable data could remove a major bottleneck in therapy development and help accelerate the delivery of medicines to patients.

 

“We’ve come together to cooperatively build the future of CMC and to encourage implementable, end-to-end digital standards that are ready now,” said Achim Frauenschuh, Co-Chair of the Consortium, and Associate Director Science and Technology Drug Substance Development at Novartis. 

 

“By sharing the cost of building pre-competitive digital foundations, as well as pooling the skills and knowledge that no single company has in-house, members gain immediate access to structured data models, standardized templates, and implementation guidance, helping them put standards into practice and directly achieve ROI.”

 

Following its first year, the Consortium, a 501(c)(6) not-for-profit organization, is now moving from proof of concept toward industry-scale adoption. Its initial priority is frictionless technology transfer between sponsors and CDMOs, targeting both ecosystem-wide and internal operational challenges.

 

The longer-term ambition is broader: connecting the digital CMC lifecycle through technologies including digital twins, knowledge management, automated content authoring, and artificial intelligence.

 

The Consortium also plans to act as a unified industry voice with health authorities, developing standards designed to support both internal operations and regulatory submissions.

 

With work already underway on digital technology transfer and structured knowledge exchange, the Consortium is positioning early members to help define the CMC standards and infrastructure that could shape the industry over the next decade.