A new industry consortium launched today aims to tackle one of biopharma’s persistent digitalization challenges: bringing chemistry, manufacturing and controls (CMC) processes into a standardized, interoperable digital environment. This launch is a pre-competitive collaboration involving pharmaceutical and biotech companies, contract development and manufacturing organizations (CDMOs), technology companies and consulting firms.

The group was established by leaders from Novartis, Thermo Fisher Scientific, Takeda, Rockwell Automation, Flagship Pioneering Medicines, Stellix, ZS Associates and QbDVision. Its objective is to develop common digital standards and infrastructure that can turn CMC information into structured, reusable data rather than leaving critical knowledge embedded in documents and static files.

While digital technologies have transformed areas such as drug discovery and clinical development, many CMC processes continue to rely heavily on documents, spreadsheets and PDF-based information exchange. That approach can make it difficult for organizations to share manufacturing and development information consistently, particularly when projects move between sponsors, CDMOs and other external partners.

The Digital CMC Consortium is seeking to address that problem by combining existing industry guidance with new standards where gaps remain. It also plans to develop implementation tools and code intended to help companies incorporate those standards into their existing workflows.

“Pharmaceutical science has already benefited from significant digital transformation in discovery and clinical development,” says Mike Stapleton, Chairman of the consortium and Chief Business oOficer at QbDVision. “CMC now has an opportunity to undergo a similar transition.”

Stapleton says the complexity of global supply chains and regulatory requirements has increased the need for organizations to exchange information in a more standardized way. He also pointed to structured, contextualized data as an important foundation for applying AI to biopharmaceutical development. Rather than treating individual documents as the definitive source of CMC information, the consortium envisions knowledge that can be represented as structured digital assets and reused across organizations and stages of development.

The consortium is initially concentrating on technology transfer between drug sponsors and CDMOs, an area where differences in data formats and processes can create substantial friction. Work is already underway on digital technology transfer and structured knowledge exchange.

“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,” said Achim Frauenschuh, Co-chair of the consortium and Associate Director of Science and Technology Drug Substance Development at Novartis.

Although technology transfer is the immediate priority, the consortium’s broader roadmap extends across the CMC lifecycle. Potential applications include digital twins, knowledge management, automated content generation and artificial intelligence. Establishing standardized data structures could help connect these technologies to the underlying scientific and manufacturing information generated during drug development.

The group also intends to engage with health authorities and establish a common industry position around digital CMC standards. The goal is for standards developed for internal operations to be sufficiently robust to support information used in regulatory submissions.

For an industry increasingly focused on using AI to accelerate drug development, the effort highlights a fundamental issue: sophisticated algorithms still depend on accessible, standardized and well-structured data. By creating common digital standards before companies attempt to scale AI across CMC operations, the consortium is positioning data interoperability as an infrastructure problem that needs to be addressed at an industry level.

The consortium is inviting additional organizations to participate in its work as it moves toward broader implementation of digital CMC standards. The consortium operates as a 501(c)(6) nonprofit organization and says its first year of work has moved the initiative beyond proof-of-concept activities toward broader industry adoption. For more information, visit the https://www.digitalcmc.org website.