Transforming Your LV Process for CAR T to a Scalable, GMP-Ready Process
Key areas of focus include:
Transitioning from research to clinical application presents numerous challenges, particularly for CAR T developers, academic institutions, and small companies at a pivotal point in their development journey. This webinar is specifically designed to address these groups, aiming to refine their process development for clinical readiness. We will emphasize the need for a shift to a structured, data-driven methodology, crucial for meeting the stringent requirements of large-scale Good Manufacturing Practice (GMP).
Our objective? To help you understand the necessity of shifting from traditional, ad hoc methodologies to a structured, data-based development approach. This segment emphasizes the importance of embracing change and innovation to overcome the limitations of the “this is how we’ve always done it” mindset.
- Quality by Design (QbD): a systematic development framework
- Design of Experiments (DOE): understanding and improving your process
- Scalability: designing a process that can be scaled up from the bench to large, industrial scale
- USP & DSP: improving production and purification
Our experts can provide insights and answer your queries to advance your CAR T therapy development. This webinar is designed to help you, and if you have additional questions, we invite you to share your questions.
