Streamlining Qualification of Custom Products in Biopharmaceutical Manufacturing: Solutions for Single-Use Systems and Cell Culture Media

The customisation of single-use systems and cell culture media (CCM) presents significant opportunities for improving pharmaceutical manufacturing efficiencies, including reduced time, enhanced quality, and optimised resource utilisation. However, the qualification of these custom products poses challenges, particularly regarding the systematic acquisition and evaluation of essential information.

This presentation will explore effective strategies for leveraging custom documentation to speed-up the qualification process of single-use assemblies and CCM. This includes:

• Key Criteria: discussing the initial qualification criteria for selecting custom products

• Overcoming Obstacles: evaluating common challenges and practical solutions in the qualification of custom single-use assemblies and CCM

• Compliance Simplified: focus on quality and regulatory compliance documentation.