Case Study
Erbi Breez™
About the Work
Erbi Biosystems, a venture-funded start-up, developed a micro-scale, automated, closed-loop, and continuous perfusion cell culture platform called the Breez™. Erbi's groundbreaking innovation mimicked larger-scale bioreactor systems but reduced the time and costs necessary for operation. The team at Erbi Biosystems turned to Build by Boyd to help design and procure a custom assembly process, establish necessary inspection and quality control procedures, and scale up a long-term manufacturing operation.
Process Development & Validation
Drawing PackageTooling & Fixturing
Assembly Process
Manufacturing
Complex AssemblyInspection & Quality
Process Optimization
Supply Chain Management
Material SourcingAlternate Supplier Qualification
Supply Chain Management
Process Development & Validation
The Erbi Breez™ project required the team at Build by Boyd to develop a drawing packet with complete tolerances and dimensional call-outs necessary for commercial manufacturing. We then optimized the assembly process, including the development of custom components and fixturing to improve efficiency and ergonomics. With these process developments complete, we successfully transferred the process into our commercial operation for long-term manufacturing.
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Manufacturing
After our Process Development & Validation work, the team at Build by Boyd transferred the assembly process into a Class 7 Cleanroom under GMP protocols. We quickly scaled up our manufacturing capacity to meet the market demand and establish a long-term stable supply of the product. Once the assembly process was operating at scale, we pursued cost reduction and process optimization efforts to reduce the cost of goods sold, improve efficiency, and increase overall capacity.
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Supply Chain Management
The Erbi Breez™ assembly has more than seventy components from twenty different suppliers. Our supply chain management team was engaged early in this program so that we could qualify and add these suppliers to our approved supplier list (ASL). As the program transitioned into commercial production, the team at Build by Boyd worked closely with Erbi to develop and maintain an accurate demand forecast. We collaborated with suppliers to pipeline the required amount of raw materials and ensure the stable, on-time delivery of the product.
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Outcomes
Erbi Biosystems and Build by Boyd successfully transferred the Erbi Breez™ products into commercial manufacturing and then optimized the process for future scale and innovation. These efforts positioned the product for future growth with additional capacity and opportunities for innovation into new applications in cell and gene therapy markets. Ultimately, Erbi Biosystem's successful market entrance and expansion led to their acquisition by a large strategic.
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Process Optimization
Manufacturing Scale-up
Acquisition by Strategic Partner
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