Development of industry-leading large-scale LVV production process towards high quality GMP vector


In recent years, the lentiviral vector (LVV) has become a vector of choice used in gene cell therapy. A standard GMP 48L Cell Factory (CF) process is not sufficient to meet manufacturing demand, especially for commercial applications. In response to this demand, AGC Biologics has developed a reproducible, high quality and quantity process for the industrial scale production of LVV. This platform consists of the production of vectors in the iCELLis® Bioreactor, downstream purification and concentration by chromatography and TFF steps, and sterile filtration and filling.

Giuliana Vallanti, Director of Global Development and R&D, Cell and Gene Therapy, AGC Biologics, shared the latest data that demonstrates the key benefits of our proven approach to evolve the LVV (48L CF) production process in a bioreactor (200L) without modifying quality attributes (CQA).

To discover:

  • Latest data results comparing three different scales: 1. GMP 48L CF standard setting; 2.reduce iCELLis® Nano Bioreactor (1L); 3. Large scale iCELLis® 500 bioreactor (200 L)
  • How to scale the process without changing Critical Quality Attributes (CQA)
  • How To Reduce Your Risk On Your Path To GMP With GMP-Like Process Development How To Perform Almost All Analysis In-House Reduces Overall Turnaround Time

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