Empowering Process Development for Viral Vector-Based Medicines

Effective process development for viral vector-based medicines is paramount for optimized process efficiency, robustness, scalability, and product quality. Well-designed processes streamline manufacturing to ensure consistent and reliable viral vector products, essential for successful advanced therapy development.

In this presentation, we will discuss how innovative process development solutions, that combine best-in-class bioprocessing expertise and state-of the-art technology with contemporary digitalization and machine-learning approaches pave the way for a highly efficient CMC pathway. How pre-defined modular building blocks and pre-established framework technologies can reduce complexity and offer adaptable resources that serve as step stone for process customization. By harnessing these methodologies, process development can significantly be expedited, process understanding can be increased and ultimately risks of failure can be mitigated.

Learning Objectives: 

1. Review the major technical hurdles when transitioning into clinical development.

2. Summarize the principles of QbD and their limitations in early process development.

3. Demonstrate how to empower process development by implementing data driven modeling.