Critical Steps To Optimize Viral Vector Manufacturing With CDMOs

By Ramesh Koukuntla, Head of Process Development & Innovation, FUJIFILM Diosynth Biotechnologies

The need for viral vectors is rapidly growing across the cell and gene therapy space, driven by novel therapeutic and oncologic applications. Amid this surge of innovative therapies, the Food and Drug Administration (FDA) and European Medicines Agency (EMA) are updating guidelines to include advanced therapies. Meanwhile, early-stage drug developers might struggle to understand the complexities of large-scale cGMP viral vector manufacture at the required quality standards.

As pharmaceutical companies navigate the complex and emerging advanced therapies field, early consultations with the FDA and partnerships with experienced contract development and manufacturing organizations (CDMOs) will ensure delivery of high-quality products to patients on a cost-effective timeline. Download the full article to learn about the recommended best practices to yield productive collaboration throughout your viral vector production.