Compressing Tech Transfer Timelines Through Digital CMC Standardization

As advanced modalities progress into late-stage clinical and commercial manufacturing, technology transfer has emerged as a central operational challenge. Even when underlying science and platform processes are mature, transferring process knowledge between sponsors and CDMOs is often slow and inefficient. Reliance on document-centric CMC workflows—spreadsheets, slide decks, and static PDFs—creates fragmentation, inconsistent version control, and limited visibility across teams. These conditions extend onboarding timelines, strain CDMO capacity, and increase compliance risk, particularly during high-stakes transitions such as tech transfer and preparation for PPQ.

Digital CMC platforms address these issues by shifting the system of record from documents to structured, validated data. They unify process definitions, risk assessments, platform knowledge, and development history within a single data model. This enables standardized workflows, real-time collaboration, and automated traceability that are difficult to achieve with manual systems. Changes to process parameters can be managed centrally, reducing redundant reviews and minimizing the risk of outdated information propagating into batch records or regulatory submissions.