Supply Chain Council of European Union | Scceu.org
Operations

Scaling From Cell Factory Systems To An iCELLis 500 Bioreactor Without Affecting Critical Quality Attributes

GettyImages-675822742-cleanroom-bioreactor

The challenge was to identify an effective, replicable, and large-scale lentiviral vector (LVV) manufacturing process, evolving from the well-established GMP 48L Nunc™ Cell Factory™ (CF) process, to meet the growing manufacturing demand – especially for market application – without affecting critical quality attributes.

Following rigorous testing, a robust, scalable, high quality and quantity process was developed for the industrial scale production of LVV for use in gene-modified cell therapy or in vivo gene therapy. Explore the details and data of the process.

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