Reducing Validation Effort at Horizon Therapeutics

Horizon's goal was to meet the validation approach agreed with the FDA for a technology transfer from a U.S. to a European site. Horizon chose to perform Extractables Assessments for all assemblies with the support of the Sartorius Extractables Simulator (ExSim). The ability to provide compliant Extractables Assessments for all assemblies to be tested as early as 4 weeks after receipt of the order was a key decision factor for choosing Sartorius' proposed approach.

Key Learning Objectives:

• Learn how Horizon was able to reduce the number of performed extractables studies from 44 to only 28, resulting in a 30% cost savings by choosing the Sartorius ExSim-based validation approach
• Discover how Horizon can now validate future assemblies consisting out of tested components in less than 1 week