Defining Viral Clearance Validation Strategies for Continuous Chromatography
We understand that Continuous Processing holds potential to enhance Monoclonal Antibody production with higher yields and lower capital costs. With any emerging technology in a regulated environment, best practices on validation strategies are still being formed.
By partnering with Bristol-Myers Squibb, WuXi Advanced Therapies collaborated on a study to prove that it was possible to decouple a Continuous Chromatographic system for Viral Clearance Validation using a single column model.
Not only is this approach effective, it also provides a framework for developing internal validation strategies that enable the transition to Continuous while demonstrating viral safety and regulatory compliance.
Presented by Alexander Schwartz and Dr. Srinivas Chollangi, the webinar explores:
- Current state of continuous viral inactivation and chromatography validation strategies
- Advantages of Continuous Chromatography compared to Batch Chromatography
- Scaling Wash and Elution conditions to ensure acceptable Impurity Clearance
- Successful Continuous simulation using AKTA model
- Strategies for detecting Virus carryover
- Impurity Clearance performance comparison