03.26.21 -- Scalable Manufacturing Of Adeno Viral Vector For Gene Therapy

The challenges and shortage of vector production reflects the fact that these materials and products are experiencing strong clinical success. Let’s celebrate the reason for this demand. To meet it, we need to industrialize and rethink how we transition from what has historically been carried out in translational clinical centers at smaller scale, using flasks and open systems, towards commercial production and methodologies.

As products progress through clinical phases there is a greater need for scalable plasmid DNA production, which must first be manufactured and purified in a GMP facility or high-quality plasmid DNA production areas. This has led to pressure on manufacturers to create the capacity and resources essential to meet the rising demand for high-quality plasmid DNA.

Companies pursuing gene therapies, and even CDMOs that want to partner with them, must figure out a way to close the gap in viral vector production. For many, this means facing a build versus buy capacity decision that has long been a part of the biomanufacturing landscape, but procuring viral vector capacity comes with even more complexity and risk.