How To Build A Process For Scale And Efficiency: Tips For Designing A Single-Use Manifold For Advanced Therapies

By Jay Collins, Product Manager, Single-use; and Chris Hofmann, Single-use Design Engineer, Charter Medical LLC

When creating a scalable process for cell and gene therapy production, developers must have an early understanding of how the components of a single-use system can be designed to streamline the journey to commercial scale.

Therapy manufacturing processes, designed with a high degree of flexibility, ultimately enhance process efficiency, reduce risk, and cut costs. Single-use manifolds, comprising bags and other components, introduce flexibility to the manufacturing process by enabling the transfer of final or in-process fluid into multiple bags simultaneously within a closed system. Customizable manifolds bring a variety of process benefits to advanced therapy manufacturing, including scalability, safety, reliability, and speed.

During the early stages of developing single-use manifolds, Charter Medical's team of expert single-use engineers frequently encounters queries about design and implementation. This Q&A addresses six common questions posed by cell and gene therapy manufacturers in the design of custom single-use manifolds for the critical handling of biological fluids.