Value Of Standardization Modularized Manufacturing Strategies For Single-Use Technologies

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

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? This white paper presents the potential power of a modularized and standardized single-use manifold design approach offered by the mAb Process Playbook Modular Manifold Library. 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?