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.
The True Cost of Product and Process Development
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:- Failed engineering or validation batches can delay launch timelines by months.
- Incomplete or poorly documented CMC development rationale fuels deviations, CAPAs, unplanned investigations, and repeated experiments to “rediscover” decisions made years earlier.
- Inefficient tech transfer processes, driven by fragmented process knowledge, can delay new site readiness and constrain the supply chain.
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 Current Reality: QbD Trapped in Static Tools
Quality by Design offers a structured way to build process knowledge. This is achieved by defining the Quality Target Product Profile (QTPP), which then drives the identification of critical quality attributes (CQAs). The next step is to understand which process parameters and materials influence CQAs, leading to the definition of critical process parameters (CPPs) and critical material attributes (CMAs). Risk assessments and Design of Experiments (DoE) often support this work. This workflow produces a scientifically justified control strategy that ensures consistent quality.
Quality by Design is not a one-time exercise; it is a lifecycle approach enriched as more data are generated and analyzed to continuously improve the control strategy, resulting in multiple benefits:
- A systematic, science- and risk-based framework for development decisions
- Deeper process understanding and increased robustness
- Greater regulatory flexibility, including the potential to operate within an approved design space and manage post-approval changes more efficiently
- Clear documentation of the impact of process parameters on product quality and the controls used to maintain that quality
- Poor traceability of decisions: It is difficult to trace the rationale behind many development decisions.
- Version control and misalignment: When documents are copied, revised, and circulated, different teams and sites may end up working from slightly different document versions.
- Knowledge loss: When subject matter experts (SMEs) change roles or leave the organization, much of the historical rationale goes with them.
- Manual, error-prone retyping: Data are often repeatedly re-entered across multiple systems and documents, introducing the potential for errors and inconsistencies.
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.
What It Really Means to Digitalize QbD Frameworks
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.
Digital QbD as a Foundation for High-Confidence Tech Transfer
Tech transfer in the pharmaceutical industry sits at the intersection of development and commercial manufacturing, and it is here that digital QbD delivers some of its most tangible value. When CMC development is grounded in a digital QbD framework, tech transfer teams inherit a structured, searchable view of CQAs, CPPs, CMAs, risks, and supporting data. Instead of searching through lengthy reports to piece together process understanding, they can quickly access the information most relevant to transferring and scaling the process.
During tech transfer, digital QbD supports:
- Risk-based planning, with activities, resources, and timelines prioritized based on the risk profile of the process.
- Faster alignment between sending and receiving sites (or between sponsors and CDMOs) because everyone is working from the same knowledge base.
- Smoother PPQ, with fewer surprises and deviations because the behavior of the process is better understood and more transparently communicated.
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.
Comparing Tech Transfer Approaches
One way to appreciate the difference digital QbD makes is to compare two tech transfer scenarios.
Scenario 1: QbD Conducted in a Document-Centric Way
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.
Scenario 2: QbD Digital From the Start
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.
Bringing QbD Into the Digital Era
Quality by Design was introduced to shift the industry from reactive quality control to proactive, science- and risk-based process design. That promise can only be fully realized when QbD is digital, connected, and reusable across the product lifecycle. Document-centric approaches trap valuable knowledge in static artifacts. On the other hand, digital QbD frameworks turn it into a strategic asset that strengthens development, tech transfer, and commercial manufacture. For organizations under pressure to deliver therapies faster, more reliably, and in compliance with increasingly demanding regulatory expectations, digital QbD is no longer optional. It is a foundational framework for fast, predictable, and inspection-ready tech transfers.
To determine your next steps, ask yourself:
- Where do your QbD processes live today?
- How quickly can you trace a process decision back to its experimental evidence?
- How easily can your tech transfer teams and receiving sites understand the rationale behind your decisions?
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.
Quality by Design (QbD) Digital Transformation Process Digitalization
Margarida Ventura
Senior Consultant in Delivery
