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Development of a Scalable Viral Vector Upstream Process for Gene Therapy

Genethon and Pall® Biotech have collaborated to demonstrate the benefits of the iCELLis® fixed-bed bioreactor as a platform for viral vector production.

The Problem: Clinical use of gene therapies to treat formerly incurable genetic diseases is advancing rapidly. Viral vectors are an important tool for introducing genes into target cells. Many gene therapies have been developed using adherent cells in 2-dimensional flatware or roller bottles but using these technologies to reach commercial-scale production represents a significant challenge. 



The Solution: The Genethon rAAV-8 process was transferred to an iCELLis Nano bioreactor. Transferring a process to the iCELLis Nano bioreactor can be easily achieved and once in place can be optimized to provide significant productivity increases and cost savings due to per example reduced plasmid DNA quantity needs. The iCELLis bioreactor enables large-scale viral vector production by providing a  3-dimensional matrix for cell growth in a small footprint. Up to 500 m2 of surface area is available in a compact bioreactor measuring 88 mm in diameter in a total volume of 75 L with pH, DO, biomass and temperature control. A key feature of the iCELLis bioreactor is that it scales by increasing the diameter of the fixed-bed while keeping the height constant with no change in aspect ratios. The height of the fixed-bed can be varied as well as the density of carrier packing. The iCELLis system comes in two formats, the iCELLis Nano bioreactor (0.53 - 4.0 m2) and the iCELLis 500 bioreactor (66 - 500 m2). Processes developed in the bench top iCELLis Nano bioreactor can be easily transferred to the corresponding iCELLis 500 system.

Development of a Scalable Viral Vector Upstream Process for Gene Therapy

Genethon and Pall® Biotech have collaborated to demonstrate the benefits of the iCELLis® fixed-bed bioreactor as a platform for viral vector production.
Genethon and Pall® Biotech have collaborated to demonstrate the benefits of the iCELLis® fixed-bed bioreactor as a platform for viral vector production.
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How could the utilization of chromatography sorbents be improved?

Pall and CMC Biologics Pave the Way with Multicolumn-Chromatography-based Downstream Manufacturing.
Pall and CMC Biologics Pave the Way with Multicolumn-Chromatography-based Downstream Manufacturing.
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Advanced Filtration Optimizes High-Viscosity Blow-Fill-Seal

What was putting a choke-hold on sterile filtration throughput? Spanish CMO Unolab switched to Pall’s polyethersulfone membrane filters and solved a challenging issue.
What was putting a choke-hold on sterile filtration throughput? Spanish CMO Unolab switched to Pall’s polyethersulfone membrane filters and solved a challenging issue.
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Single-Use Technologies In A 1000 Liter Plus Monoclonal Antibody Process

How to confirm that single-use manufacturing is feasible for mAb processes at a 1,000-liter plus scale? Pall helped Rentschler to find the answers.
How to confirm that single-use manufacturing is feasible for mAb processes at a 1,000-liter plus scale? Pall helped Rentschler to find the answers.
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Column Packing - Changing Art To Science

A multinational vaccine company noted that creep in standard operating procedure (SOP) execution and operator error was significantly affecting productivity. Could a column packing success rate of 62% be improved and labor costs reduced?
A multinational vaccine company noted that creep in standard operating procedure (SOP) execution and operator error was significantly affecting productivity. Could a column packing success rate of 62% be improved and labor costs reduced?
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