Single-Use Design Redefined: Webinar Transcript Summary
Introduction
Welcome, and thank you for joining us today. We’re excited to introduce you to The Forge, our single-use design tool that streamlines the development of bioprocess assemblies. This project has been years in the making, and our goal is to build a strong user community that helps us refine and enhance it over time.
About Vulcan Bioworks
Vulcan Bioworks is an engineering company bridging the gap between the next generation of biopharmaceutical processing needs and fit-for-purpose single-use solutions. The biopharma industry faces increasing demands for efficiency, adaptability, and standardization, yet traditional approaches to single-use design often create unnecessary complexity and inefficiencies.
Through innovative products and novel strategies, we enable the efficient manufacturing of mindfully single-use products, helping to catalyze the revolution of precision medicine. The Forge was created to streamline single-use system design, reduce redundancy, and provide a neutral, intelligent platform for standardization—without limiting the flexibility required for groundbreaking therapies.
The Challenge: Lack of Standardization in Single-Use
The industry faces a challenge: how do we achieve standardization in single-use design? Many organizations want to simplify and reduce SKUs, yet there is an ever-growing demand for new, custom designs. The Forge was developed to address this challenge by providing a flexible, standardized approach to single-use design.
The COVID-19 pandemic highlighted critical supply chain inefficiencies. While there was an ample supply of raw materials like bag film, tubing, and connectors, once assembled and irradiated, these components became locked into specific designs and couldn't be repurposed. This led to widespread shortages and delays.
A fundamental issue in single-use processing is the lack of a common language. Each company—sometimes even separate sites within the same company—uses different terminology and specifications, making standardization nearly impossible. Our approach with The Forge is to tackle this problem at its root: by creating a neutral taxonomy and digital design verification system.
Introducing The Forge
The Forge is a web-based, free-to-use design tool that helps users create and validate single-use assemblies efficiently. Key features include:
Neutral Taxonomy: A standardized language for components and assemblies.
Rules-Based Verification: Ensuring compatibility and compliance with industry best practices.
Real-Time Comparison: Matching new designs to existing validated assemblies.
E-Commerce Integration: Rapid prototyping and procurement of custom assemblies.
Let’s walk through a demo of The Forge in action.
Live Demo: How The Forge Works
Users select components from an intuitive menu-driven interface.
Color-coded indicators help ensure compatible connections (e.g., 3/8" tubing only connects with 3/8" barbs).
Common elements like gaskets, caps, and clamps are auto-suggested for efficiency.
A rules engine prevents incorrect component combinations, reducing design errors.
Once an assembly is complete, users can generate a BOM, spec sheet, or export a CAD file.
Through integrated e-commerce functionality, users can immediately order prototypes.
This entire process, which traditionally takes weeks or months, can now be completed in just minutes.
Beyond Design: SKU Management & Library Standardization
One of the most exciting capabilities of The Forge is library management:
Many companies have thousands of slightly different SKUs with no easy way to consolidate them.
The Forge introduces the Single-Use Genome, a digital framework that allows users to compare new designs against existing validated assemblies.
Users can see whether a proposed design is an exact match, a near match, or a completely new assembly.
This approach promotes reuse of existing designs rather than unnecessary customization, improving supply chain efficiency.
Standardization Through Customization
Rather than imposing a fixed set of standards, The Forge enables users to define their own best practices while aligning with industry-wide methodologies. This bottom-up approach allows for continuous improvement and organic standardization without disrupting validated processes.
We believe this method will finally solve the long-standing challenge of standardization in single-use bioprocessing.
Supply Chain Visibility & Regulatory Compliance
Another major advantage of The Forge is real-time supply chain tracking:
Users can analyze "where-used" data to see where specific components are deployed across multiple sites.
This level of visibility helps optimize inventory, prevent stockouts, and streamline procurement.
The system also integrates with ERP and QMS platforms for enhanced traceability.
By linking designs to supplier specifications and regulatory data, companies can ensure compliance with global bioprocessing standards.
Q&A Session
Q: Is the e-commerce functionality available in the free version?
A: Yes. Users can design an assembly and purchase it directly. If components aren’t immediately available, a "Request a Quote" option allows for sourcing.
Q: What tubing sizes are currently supported?
A: We support 1/8", 1/4", 3/8", and 1/2". More sizes will be added based on customer feedback.
Q: Can multiple sites within the same company share a reference library?
A: Yes. The Forge supports single-tenant environments, meaning companies can set up shared databases that provide visibility across multiple locations.
Q: How can suppliers add their components to The Forge marketplace?
A: Suppliers can collaborate with us to integrate their standards and preferred components into the tool. This enables seamless supplier-to-customer engagement.
Q: What about over-molded connections and custom junctions?
A: We are actively expanding support for over-molded T’s, Y’s, and complex junctions. We welcome supplier partnerships to further develop this functionality.
Q: Does The Forge require special hardware?
A: No. It is cloud-based and accessible via any web browser. Users can design assemblies on desktops, laptops, or tablets.
Q: How does The Forge handle intellectual property and data security?
A: Enterprise accounts operate on secure, private servers. Free users can export designs without linking any identifying information.
Final Thoughts & Next Steps
We invite you to explore The Forge and see how it can transform your single-use design process. Here’s how you can get started:
Try It for Free: Visit our website and start designing today.
Enterprise Solutions: For organizations looking to digitize their libraries and standardize designs, we offer customized implementations.
Supplier Partnerships: If you’re a supplier looking to integrate your components into The Forge, we’d love to collaborate.
Rapid Prototyping: Our platform enables instant prototyping and purchasing to accelerate development timelines.
For more details, visit our website.
Thank you all for attending! We look forward to continuing the conversation.