Critical Challenges and Solutions for Viral Vector Manufacturing – Scaling Process
Scaling up viral vector manufacturing processes presents a new set of challenges and decisions. Retrofitting considerations involve adapting and optimizing the manufacturing process to meet increased volume demands. Anticipating and optimizing viral vector titers, ensuring product quality through process control, addressing vector-specific requirements, and reducing production times are crucial factors in retrofitting. Adherent cell proliferation platforms offer simplicity and ease of monitoring, while suspension platforms better reflect natural cell physiology and enable higher-quality end products. Microcarrier hybrid systems combine the advantages of both platforms. Capacity, technology expertise, acclimation of cell lines, and processing times are key considerations when choosing between platforms. Adapting cells from adherent to suspension growth systems requires careful optimization and predictive modeling to maintain therapeutic safety and efficacy. The use of closed systems and single-use components can reduce production times by streamlining sterilization, cleaning, and sampling tasks.