TECH OUTLOOK 8NOVEMBER 2023IN MY OPINIONBy Rachel Legmann, PhD, Senior Director of Technology, Gene Therapy, Repligen Corp.GENE THERAPY--THERAPEUTIC VIRAL VECTORS; MANUFACTURING, CHALLENGES, AND INNOVATIONPlatform approach for intensifying virus-based therapeutics process manufacturingExpanding the disease indications of gene therapies beyond rare diseases as well as developing more complex but also more fragile target viral vectors require not only expanding existing manufacturing facilities but also developing new capacities. The manufacturing processes that enabled the first landmark gene therapies to successfully complete clinical trials and regulatory approvals lack the efficiency and productivity required to meet current and future demand. Special requirements on the viral vector manufacturing processes, such as low cell density, low production, and instability, create challenges in their scale-up that cannot be solved by traditional platform approaches. Advanced technologies are needed to meet the vector demand and provide the required reliability and robustness for manufacturing, enabling gene therapies to meet their full potential. Challenges across the vector process workflow A key challenge in the field of therapeutic viral vector manufacturing is maximizing vector yield during the entire process at all scales. Current upstream viral vector
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