In recent years, Lentiviral vector (LVV) has become a vector of choice used in gene-modified cell therapy. A standard GMP 48L Cell Factory (CF)-based process is not enough to meet the manufacturing demand – especially for commercial applications. In response to this demand, there is now a reproducible, high quality and quantity process for the industrial scale production of LVV available. This platform consists of vector production in the iCELLis® Bioreactor, downstream purification and concentration by chromatography and TFF steps, and sterile filtration & filling.
During the webinar, the speakers present data obtained in:
- a standard GMP 48L CF-based setting
- scale down iCELLis® Nano Bioreactor (1L)
- full scale iCELLis® 500 Bioreactor (200 L)
The results demonstrate key advantages of an approach to scale the already established platform (48L CF) in a bioreactor (200L) without changing critical quality attributes (CQA) of the process.
- Latest data results comparing three different scales: 1. standard GMP 48L CF-based setting; 2. scale down iCELLis® Nano Bioreactor (1L); 3. full scale iCELLis® 500 Bioreactor (200 L)
- How to scale the process without changing critical quality attributes (CQA)
- How to de-risk your path to GMP with GMP-like process development How performing almost all analytics in-house reduces overall turnaround time
- Dr Giuliana Vallanti, Director, Development and Global R&D, Cell and Gene, AGC Biologics
- Dr Marianna Sabatino, Head of Product Sciences, Autolus Ltd
- Professor Alessandro Aiuti, Deputy Director, Clinical Research, San Raffaele Telethon Institute for Gene Therapy (SR-TIGET)