Large-scale LVV production: from industry-leading process development to high quality GMP vector

Thursday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET

Sponsor

Large-scale LVV production: from industry-leading process development to high quality GMP vector

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, AGC Biologics has developed a reproducible, high quality and quantity process for the industrial scale production of LVV. 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, AGC Biologics will 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 our approach to scale the already established platform (48L CF) in a bioreactor (200L) without changing critical quality attributes (CQA) of the process.

AGC Biologics is a leading global CDMO, providing industry-leading process development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and cell therapies.

Attendees will discover:

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

Giuliana Vallanti

Director, Development and Global R&D, Cell and Gene, AGC Biologics

Giuliana Vallanti is Development and Quality Control Director and Qualified Person at MolMed. She joined MolMed in 2005 and worked with growing responsibilities in Development and Quality Control units, contributing to the development of processes and assays in cell and gene therapy field.

She has main experiences in the development and industrialization of T- and haematopietic cells transduction processes with lentiviral and retroviral vectors. She worked on the development of GMP processes for large scale vectors production and purification.She holds a degree in Biology from Università degli Studi – Urbino and a Ph.D. in biochemical and pharmacological methods with a study on Lentiviral Vector for gene therapy anti HIV-1.

Alessandro Aiuti

Deputy Director, Clinical Research, San Raffaele Telethon Institute for Gene Therapy (SR-TIGET)

Alessandro Aiuti initially focused his research studying diseases of the coagulation and HIV infection. His research on hematopoietic stem cells (HSCs) led to the discovery of the first chemokine produced by bone marrow cells inducing migration of human HSCs. His current research is focused on pediatric hematology and immunology and specifically on primary immunodeficiencies, genetic diseases of the immune system. He pioneered the successful gene therapy clinical trial for SCID patients that lack adenosine deaminase (ADA), a fatal disorder of purine metabolism and immunodeficiency. This clinical trial, now completed, introduced a conditioning regimen to favor the engraftment of gene corrected cells and is considered to be among the most important clinical result of gene therapy for genetic diseases. Gene therapy for ADA SCID has been designated as Orphan Drug in Europe and USA. His most recent research with HSCs transduced with lentiviral vectors led to the successful application of therapy for another primary immunodeficiency, Wiskott-Aldrich syndrome.