Propelling Gene Therapies From Lab To Clinic

By Lan Ly, PhD, Business Lead, Viral Gene Therapy, FUJIFILM Diosynth Biotechnologies

Gene therapies are a promising new approach to treating a wide range of diseases, but they present unique challenges in their early development and manufacture. Unlike conventional biologics, such as monoclonal antibodies, which are typically manufactured using well-established cell lines, gene therapies are often delivered using more complex bioprocesses that can result in low and inconsistent yields and highly heterogeneous products. The lack of established processes and analytical methods, and the ever-evolving regulatory landscape, can further complicate the path to commercialization.

As a result of these challenges, many companies are turning to contract development and manufacturing organizations (CDMOs) such as FUJIFILM Diosynth Biotechnologies (FDB) to help them bring gene therapies to market. CDMOs have the expertise and experience in biomanufacturing that can help companies overcome the challenges of early stage development and optimize biomanufacturing processes for commercial scale.