Exploring Options for Dual Sourcing of Single-Use Components

摘要

A s the bioprocess industry Aprogressively adopts single-use technologies for large-scale manufacturing (l, 2), biomanufacturers' increased reliance on integrators for critical production equipment continues to raise concerns about supply chain security. The need to mitigate risks associated with the supply of single-use components (e.g., bioreactors, aseptic connectors, tubing, filters) has led to growing interest in the dual sourcing of those materials. To that end, integrators and end users alikeare exploring the definition of functionally equivalent products, how functional equivalency can be demonstrated, and strategies for managing functionally equivalent parts.