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

Sponsor

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

Dr Giuliana Vallanti

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

Giuliana Vallanti is Director, Development and Global Gene Therapy R&D, Qualified person.

She joined AGC bio, former 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 strong 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 in close systems. 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.

Dr Marianna Sabatino

Head of Product Sciences, Autolus Ltd

Dr Marianna Sabatino who is head of the Product Sciences function at Autolus a clinical stage company involved in the development of CAR T for a broad spectrum of cancers. She has been involved in development of production process and overall CMC strategy for cell therapy products for over 10 years across academia and Industry. Marianna was at Kite Pharma for few years leading the development of company’s product pipeline and supporting the Biologics License Application filing for Yescarta™. She was trained as Medical Oncologist and received her Medical Degree and professional training in Medical Oncology from the University of Siena, Italy.

Professor Alessandro Aiuti

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

Alessandro Aiuti is Deputy Director, Clinical Research Coordinator, Head of Unit on Pathogenesis and Therapy of PID and Head of Pediatric Clinical Research Unit of SR-Tiget, Milan; Director of the Pediatric Immunohematology Unit, San Raffaele Hospital, Milan; full Professor of Pediatrics, and Director of the Residency Program of Pediatrics at Vita-Salute San Raffaele University, Milan, Italy.

He is M.D., specialized in Immunology, and Ph.D. in Molecular and Cell Biology. In 1998 he obtained the National Board in Hematology.

His main interests are hematology, immunology and pediatrics, particularly in the study of PID. His main domains of research are: HSC gene therapy for genetic diseases (PI of 5 clinical trials: ADA-SCID, WAS, β-thalassemia, MLD and MPS1), clonal dynamics of hematopoiesis, genetics and pathogenesis of primary immunodeficiencies.

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