Design Once, Deploy Anywhere: Why Digital Modularity Is a Turning Point for Bioprocessing
The bioprocessing industry stands at a crossroads. As the push toward more agile, decentralized, and sustainable manufacturing models accelerates, legacy approaches to single-use system (SUS) design are showing their limits. Traditionally, every system—whether for upstream, downstream, or fill-finish operations—has been designed in isolation, often locked to a specific supplier’s ecosystem, with little opportunity for reuse or standardization.
This bespoke design paradigm introduces significant delays, validation burdens, and compliance risks—particularly as regulatory expectations rise and global manufacturing networks expand. What the industry needs is a modular, digitally-enabled approach to system design: one that prioritizes interoperability, traceability, and reuse.
Why the Industry Is Moving Toward Modularity
Modularity in this context refers to the use of standardized, interchangeable building blocks in process design. It’s not just a mechanical concept—it applies to digital design artifacts, workflows, and documentation.
The drivers for modularity include:
Design Reuse: Modular systems enable reuse of validated assemblies and subassemblies across projects, reducing development time and improving consistency.
Change Management: When a modular component needs to be updated or replaced, it can be done without redesigning the entire system—critical for maintaining validated states.
Process Scalability: Modular components can be adapted across scales (e.g., from clinical to commercial), simplifying tech transfer and reducing risk.
Supplier Flexibility: With a common taxonomy and defined interfaces, systems can be designed in a supplier-agnostic way, improving sourcing options and supply chain resilience.
This approach isn’t just about operational efficiency—it directly impacts the reliability and reproducibility of manufacturing processes.
The Digital Infrastructure Behind Modularity
For modularity to work in practice, especially in highly regulated environments, it requires robust digital infrastructure:
1. Rules-Based Design Verification
Systems must be built with embedded logic that verifies compatibility (e.g., pressure ratings, flow rates, material compatibilities) at the point of design. Tools like The Forge apply these principles to prevent errors before they occur—mitigating rework and ensuring regulatory compliance from the outset.
2. Neutral Taxonomy and Metadata Standards
A neutral taxonomy allows components from different suppliers to be described in a consistent, function-based manner. This is essential for enabling cross-supplier interoperability and for effective digital comparison and selection.
For example, two filters from different suppliers may differ in branding and minor specifications but serve the same function within a system. A neutral taxonomy abstracts these to functional descriptors, facilitating interchangeability and simplifying qualification processes.
3. Digital Libraries and Repositories
A centralized repository of pre-qualified components, assemblies, and full system templates enables design reuse and traceability. With version control, audit trails, and metadata tagging, these digital libraries support both compliance and knowledge retention across projects.
Regulatory Context: Aligning with Quality by Design and Data Integrity
Regulators are not only open to these ideas—they’re increasingly expecting them.
ICH Q8(R2) emphasizes the importance of design space and knowledge management, both of which are enhanced by modular approaches.
FDA guidance on single-use systems (e.g., for biologics manufacturing) stresses the need for robust supplier management, traceability, and risk assessment—areas where digital modularity excels.
Annex 1 of EU GMP underscores the critical role of risk-based design, especially for sterile manufacturing systems.
Moreover, digital modular design platforms support ALCOA+ principles of data integrity (Attributable, Legible, Contemporaneous, Original, Accurate, and more). With real-time audit trails and structured metadata, designs are not only compliant—they are verifiable and transferable.
Practical Implications for Bioprocess Teams
For engineers and quality teams, the implications are concrete:
Faster design cycles: Pre-qualified components and templates reduce design time.
Easier validation: Reused assemblies with documented performance simplify PQ/QA processes.
Cross-functional alignment: A shared digital platform aligns process engineers, quality teams, procurement, and operations.
Global scalability: Standardized, modular designs facilitate deployment across sites with minimal rework.
Where The Forge Comes In
The Forge by Vulcan Bioworks is built from the ground up to make digital modularity not just possible, but practical. It combines rules-based design verification, a neutral taxonomy for supplier-agnostic compatibility, and real-time e-commerce integration—enabling teams to design, verify, source, and scale single-use systems faster and with greater confidence.
Whether you're looking to accelerate tech transfer, simplify validation, or build a global design library, The Forge equips you to design once—and deploy anywhere.
Conclusion: Toward a More Resilient and Scalable Biomanufacturing Model
The promise of modularity isn’t new—but until recently, the tools and infrastructure needed to support it in bioprocessing have been lacking. Today, with digital platforms that enforce rules, manage taxonomies, and integrate with supply ecosystems, modularity is not only possible—it’s rapidly becoming essential.
In an era where speed, compliance, and sustainability must coexist, digital modularity offers a new path forward: one that turns every validated design into a reusable asset and transforms every project into a faster, more reliable process.