Quality by Design (QbD) is the dominant framework for robust, science- and risk-based process development in the (bio)pharmaceutical industry, especially in an era where product pipelines are more complex, modalities are more diverse, and regulatory pressure to deliver safe, effective therapies as fast as possible is relentless.
On the company’s side, timelines are more demanding, resources are limited, and the costs of rework or delays in process development show up in budget overruns, slower time to market, supply shortages, and lost competitive advantage.
Quality by Design helps organizations move beyond empirical and tacit knowledge toward structured and deep process understanding, designing quality into the product and process from the start. However, while many companies have embraced QbD in principle, few have managed to implement it in a scalable way. Many still document QbD outputs in static documents and disconnected spreadsheets, making it difficult to leverage that knowledge across all stages of the product lifecycle.
This is where digitalization comes into play. When QbD frameworks are implemented in a digital, structured environment, they become a dynamic backbone for CMC development with knowledge that can easily be shared. In turn, organizations can capture and reuse process knowledge across sites, products, and lifecycle stages, setting costly activities such as tech transfers up for predictable and scalable success.
From early formulation through scale-up, process characterization, tech transfer, and process performance qualification (PPQ), organizations invest heavily to consistently deliver the intended product quality at commercial scale. These activities are resource-intensive, time-consuming, and highly specialized.
Beyond direct development costs, numerous indirect costs arise from gaps in process understanding or weak knowledge management, including:Every missing piece of process understanding, undocumented rationale, or inconsistency between sending and receiving sites comes at a price. Investing in robust, well-managed process knowledge is a strategic necessity to streamline CMC development and improve pharmaceutical tech transfer efficiency.
The result is that QbD, which is meant to be a living, evolving framework for process understanding, becomes stuck in static, scattered documents. To unlock its full value, QbD must become truly digital.
Digitalizing QbD is about much more than scanning documents or moving them to the cloud. It means transforming QbD from document-based outputs into structured, connected data that can be queried, analyzed, and reused across the lifecycle.
At the heart of this approach is a centralized QbD knowledge backbone that serves as a single source of truth for product and process knowledge, presented in a structured, version-controlled, collaborative, and traceable way.
ValGenesis iCMC™ is a smart digital solution that redefines CMC development and technology transfer by unifying process design, analytical development, and end-to-end risk management into a single, structured platform. Grounded in QbD and quality risk management (QRM) best practices, iCMC helps teams accelerate process optimization, ensure regulatory compliance, and reduce costs through centralized knowledge, intelligent automation, and scalable collaboration.
Viewed from a lifecycle perspective, digital QbD creates a digital thread that strengthens an organization’s foundation for managing changes, expansions, and long-term improvements.
One way to appreciate the difference digital QbD makes is to compare two tech transfer scenarios.
The sending site compiles a large tech transfer package that includes risk assessments, process descriptions, and control strategies in the form of static documents. The receiving site receives a static snapshot of the process but struggles to understand how the pieces fit together. Key rationales are scattered across files and email threads. Clarification calls multiply as engineers try to interpret ambiguous ranges or reconcile conflicting versions of documents. When PPQ begins, unexpected deviations emerge because some process sensitivities were not clearly communicated or fully understood.
The sending site shares access to a live QbD knowledge base with the receiving site. SMEs at the receiving site can explore CQAs, CPPs, correlation analysis, and risks interactively, drilling into the experiments and data behind key decisions. They identify potential challenges specific to their equipment and utilities early and adjust plans accordingly. When changes are needed, impact analyses are performed using the same digital backbone, ensuring that nothing critical is overlooked. As PPQ runs, results feed back into the QbD framework, refining process understanding.
In both scenarios, the science is fundamentally the same. The difference lies in how that science is captured, shared, and used. In the manual, static scenario, knowledge management becomes a bottleneck. In the digital QbD scenario, knowledge becomes an enabler, reducing deviations, accelerating PPQ, and shortening the time to consistent commercial manufacturing.
If the honest answers reveal gaps, now is the time to act. Start by assessing your current QbD practices, define a vision for digital QbD that fits your organization, and explore solutions that can help you build that digital backbone. The result is fewer surprises, smoother tech transfers, and a shorter path from development to patients.
Download the Industry Insight, Transforming Pharmaceutical Development: Combining Digital Platforms and QbD Principles, to learn more about how ValGenesis enables CMC development through the application of digital QbD frameworks.