In a recently published article by PharmTech.com, Naveenganesh Muralidharan, Sr. MSAT Manager, was interviewed about a timely topic in the advanced therapies industry - can cell and gene developers take lessons from monoclonal antibody product manufacturing as they look to scale their viral vector product?
He highlighted that while both products rely on a similar synthesis process: a biochemical reaction-based process and the use of cell culture vessels/bioreactors - it may not be that simple.
Shared Production Challenges
Monoclonal antibodies (mAbs) and viral vectors share some production similarities but face distinct challenges. While both involve biochemical processes and cell culture, viral vector manufacturing poses unique obstacles. Viral vectors, crucial in gene therapy scale-up, differ in their integration into host cell DNA—lentivirus vectors allow permanent integration, while adeno-associated virus (AAV) vectors are more transient.
Diversity in viral vector production
Drawing from mAb manufacturing experience, some lessons can be applied to viral vector production, leveraging tools, technologies, and infrastructure. However, viral vector processes vary widely between manufacturers, lacking the standardized depth of knowledge seen in mAb production. Challenges include impurities like host-cell DNA and plasmid DNA, requiring careful risk assessments. Smart scaling-up strategies involve early planning, transitioning to 3D bioreactor-based processes, optimizing unit operations, and exploring staggered manufacturing campaigns. As the gene therapy market grows, a shift towards suspension bioreactor-based processes is observed.