Workshop A: Solving Out of Specification (OOS) Issues in Early- Stage Cell Therapy Manufacturing
Time: 9:00 am
day: Workshop A
Details:
Out of Specification (OOS) results are a common and challenging issue in early-stage cell therapy manufacturing, where process variability can lead to delays and increased costs. This workshop will focus on identifying and addressing the root causes of OOS issues, as well as implementing proactive risk management strategies to ensure product consistency in the early phases of development.
- Root Cause Analysis of Early-Stage Process Failures: Methods for identifying key process variables that lead to OOS results, including cell viability and expansion issues
- Proactive Risk Management Strategies: Techniques for detecting and mitigating potential failure points early in process development to reduce the likelihood of OOS events
- Implementing Corrective Actions for OOS Consistency: Best practices for defining and executing corrective actions that ensure long-term process stability and consistency in early-phase manufacturing
