Developing Scalable, Global Solutions For Cell & Gene Manufacturing

Cell and gene therapies hold immense promise for treating complex, monogenic diseases and transforming patient outcomes, offering the potential for curative, one-time treatments. However, these advanced therapies face significant challenges in their manufacturing and commercialization. Viral vectors, the most common gene delivery mechanism, have demonstrated success but are complicated by issues of accessibility, particularly on a global scale. Most current cell therapies are autologous, derived from a patient’s own cells, leading to complex logistics, supply chain hurdles, and bespoke manufacturing processes. Additionally, the regulatory landscape for these therapies is evolving, and the sensitive nature of the biologics requires meticulous testing and expertise for safe and efficient delivery.

Key challenges include diverse regulatory requirements, supply chain complexities such as patient pre-screening, direct-to-patient cold chain shipping, and third-party manufacturing reliance. To address these challenges, organizations like Novartis Contract Manufacturing have invested heavily in developing a global, integrated supply chain and manufacturing network. This includes in-house production capabilities for plasmid DNA, stringent quality control, and optimized operations that reduce reliance on third parties and enhance cost efficiency. By streamlining production and internalizing key processes, Novartis Contract Manufacturing aims to mitigate risks, improve flexibility, and ensure the successful delivery of life-changing therapies to patients around the world.