Single-Use Systems in Commercial Biologics: Supply Risk and Qualification

Summary

Single-use technology now runs commercial biologics processes, which turns supplier change notifications and extractables data into supply risks. This paper covers qualification and dual-sourcing strategies.

Key takeaways

1. 01Managing supplier change notifications without line stoppages
2. 02Extractables and leachables data you need at each stage
3. 03Dual-sourcing qualification in practice
4. 04Inventory strategies for critical single-use assemblies

Written for

• Bioprocess leads
• Supply chain
• MSAT teams