Single-Use Solutions For Research And Process Development

By Robert Hendrix, Staff Engineer, Systems Design, Thermo Fisher Scientific; Kayla J. Spivey, Content Specialist III, BioProduction, Thermo Fisher Scientific; and Levi M. Larsen, Market Intelligence, Analyst III, BioProduction, Thermo Fisher Scientific

Single-use technology (SUT) has been a long-standing choice for biopharmaceutical manufacturers striving to reduce the time and cost needed to bring their products to market. While the promise of reduced costs, flexibility, and faster pathways to market has continued to grow, the industry’s appetite for single-use materials continues to increase. The traditional approach taken in single-use design has driven biopharmaceutical manufacturers to leverage risky single-source supply chain strategies for the design and sourcing of complex, optimized, custom single-use solutions, to meet a wide range of process-specific applications, even when unnecessary. This has been further complicated by design philosophies that, born from historical constructs, are not reflective of the recent gains by improved manufacturing processes for single-use manifold subcomponents. The perils associated with complex, one-off, limited-application, or sole-sourced products were why many supply chains failed to meet customer demands during the SARS-CoV-2 crisis.

Can supply chain assurance be maintained while offering an array of possibilities to achieve complex process designs? Our standardized and modularized single-use design approach allows us to deliver on both flexibility of design and supply chain assurance. The following case studies present the potential power of a modularized and standardized single-use manifold design approach. Since modularization is able to impact a wide variety of business-critical areas including supply chain optimization and robustness, quality improvements by human factor engineering principles, and technology transfer efficiencies, what benefits would a modularized and standardized single-use design approach give to your organization?