Since the first gene therapy was administered in 1990, the field has witnessed remarkable clinical successes and difficult setbacks. This push and pull continues as advancements in science and technologies move the field forward but also bring new challenges into sharper focus.
Among the challenges that loom over gene therapy innovators is the imperative to create efficient, high yield, cost-effective and scalable manufacturing processes to produce viral vectors for nucleic acid delivery. It’s been estimated that more than 70% of clinical trials featuring novel modalities rely on this delivery approach, the production of which requires specialized skillsets and manufacturing strategies and contributes to the high cost of these therapies. So where to begin?
In some cases, templates from monoclonal antibody manufacturing have been adopted for viral vector production. While this was a good start, standardized methods and fit-for-purpose workflow technologies that address the unique development and manufacturing needs of viral vectors are essential. Access to capacity and expertise, a simplified pathway to GMP manufacturing, a shorter process development timeline, and a reduction in the exorbitant fixed costs associated with facility development are needed to truly disrupt the gene therapy manufacturing space.
The good news is that the evolution towards these mission critical objectives is well underway.
Learn how adopting a holistic, integrated approach to viral vector manufacturing is moving the gene therapy field forward with giant strides versus incremental steps.
