As cell & gene therapy and genomic medicine pipeline continues to mature, process development for viral vector is becoming critical for drug developers for the next phase, to deliver a quality, transformative cure to patients with affordability. The recent investments such as Novartis-Samsung Biologics $81m contract for viral vector manufacturing, Resilience raising $625m towards biomanufacturing capabilities including stable cell lines for viral vector production pave the foundation for scientific and technology innovations.

With better understanding of these novel nanoparticles, developability and cell line development, the ability to optimize AAV, LV formulation and define robust CQAs are critical to drug developers’ ability to increase scalability with efficiency, reduce cost of goods and most importantly, ensure product quality control for patients.