Transforming Your LV Process For CAR T

Shifting from traditional, ad hoc methodologies to a structured, data-based development approach to create 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 emphasise 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 emphasises 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 expert can provide insights and answer your queries to advance your CAR T therapy development.

If you have additional questions, we invite you to share your questions.

NecstGen Services

We offer process development solutions, contract preclinical/ GMP manufacturing and cleanroom rental for Cell and Gene Therapies to clinicians, academic, small, medium, and large commercial organisations worldwide.

Viral Vector Manufacturing & Development

Cleanroom Rental

Cell Therapy Manufacturing & Development

About Us

NecstGen is a non-profit CDMO and Centre of Excellence for Cell and Gene Therapy located in a purpose-built GMP facility in Leiden, The Netherlands. Dedicated to the field of Cell and Gene Therapies, we provide expertise and
capacity to focus on patient solutions.

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