A right-first-time approach to development

By Tatiana Nanda, Director and Program Leader and Brian Tomkowicz, Sr. Director, Vector Engineering & Manufacturability, Center for Breakthrough Medicines

The industrialization of cell and gene therapies (CGTs) is a prominent issue in the biopharma industry. These novel medicines have rapidly advanced to the stage where both significant efficacy and safety have been achieved in the clinic. Unfortunately, the existing manual, labor-intensive, open lab-scale manufacturing solutions for viral vector production and genetic modification of cells are not practical to properly commercialize these innovations.

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