Pre-Competitive Industry Consortium
Uniting the Industry Around Digital CMC Standards
Uniting in a pre-competitive format, we build and integrate business processes and data specifications to modernize the CMC ecosystem, replacing static boundaries with interoperable digital models built for the age of AI.
The Challenge
Our Grand Challenge: Unifying the Industry to Accelerate CMC.
~10 years
Average timeline required to bring a therapy through traditional CMC workflows to market.
CMC workflows remain on the critical path to approval and launch, facing increased pressure as scientific discovery accelerates. While bringing a therapy to market has historically taken nearly a decade, keeping pace with modern science requires a foundational shift in how manufacturing knowledge is structured and shared.
Modernizing CMC requires starting with a unified understanding across both the business process layer and the data layer.
Because no single company or vendor can solve an ecosystem-wide challenge alone, the Digital CMC Consortium brings domain leaders together in a pre-competitive format to build open, standardized specifications that keep critical therapies moving forward.
Global, Usable Standards
An Enhanced, Digital Knowledge Standard Ready for Adoption.
To eliminate friction in technology transfer, the Digital CMC Consortium delivered tangible tools within its first six months. Designed for seamless system-neutral exchange, our specifications harmonize the data that moves across organizational boundaries while leaving your proprietary science, internal systems, and custom workflows completely intact. Phase 1 proof-of-concept deliverables designed to demonstrate measurable operational efficiency gains.
6
Months to first output
2
Standardized digital specifications
8
Cross-industry aligned organizations
Our Contributors
Powered by Industry Leaders
The Mission
Connecting People and Knowledge to Modernize CMC
Ecosystem-wide change requires a unified approach to how teams collaborate and share knowledge. The Digital CMC Consortium leverages collective industry expertise to create open business process models and machine-readable standards. By actively ushering in new ways of working, we empower organizations to eliminate redundant effort and achieve operational efficiency.
Prioritize patient outcomes
Streamline manufacturing handoffs to shorten the timeline between discovery and patient delivery.
Eliminate handoff friction
Unite to replace fragmented handoffs with standardized business processes, giving the industry proven frameworks that skip trial and error and enable direct collaboration.
Unlock organizational agility
Maximize resource potential, allowing teams to scale operations, reduce rework, and navigate regulatory pathways with confidence.
Standardize Interfaces, Preserve Flexibility
Standardize shared knowledge models and interfaces required for seamless handoffs, without prescribing science, technology platforms, or company-specific ways of working.
The Future of CMC
Governed Knowledge Foundations for Advanced Automation and AI
AI is not the starting point; it is the end benefit of disciplined knowledge structuring. We build FAIR-aligned standards that ensure traceability and seamless handoffs, laying the necessary foundation for automation and qualified predictive models.
Automate
Cross-organization data handoffs and repetitive tasks
Analyze
Interconnected manufacturing and process knowledge
Predict
Process & quality outcomes
Optimize
Cycle times, resource utilization, and time to market
Assembling Expertise
Uniting Domain Leaders Across the Ecosystem
We bring together forward-thinking organizations and subject matter experts from across biopharma and technology to build shared standards. We are open to everyone, and members will actively shape the future of digital CMC while gaining access to Consortium deliverables, including standardized templates, machine-readable data models, and implementation guidance.
Pharma, Biotech & CDMOs
Companies advancing therapies from development to commercial manufacturing or strengthening CMC capabilities.
Consulting & Regulatory Experts
Organizations providing strategic, operational, or regulatory guidance.
Technology & Data Partners
Companies focused on cloud, automation, and digital infrastructure.
Health Authorities & Industry Organizations
Regulatory bodies, other global health and industry organizations, institutions, and associations contributing research and industry perspectives.
Manufacturing & Site Leadership
Operational executives driving facility fit, scale-up, and site performance.
Development & MSAT Experts
Scientists and engineers standardizing product and process knowledge and operations.
Data & Technology Leaders
Architects leading enterprise data strategy, analytics, and system integration.
Regulatory & Quality Leaders
Quality directors establishing data integrity and accelerating review timelines.
Join Us
Shape the Future of Digital CMC
Share a few details about your background and organizational focus. Our leadership team will get in touch to discuss membership options and upcoming initiative roadmaps.