Continuous Biomanufacturing

Continuous bioprocessing is replacing batch manufacturing for biologics, accelerating production and reducing cost-of-goods. The session covers perfusion bioreactors and intensified processes, real-time release testing (RTRT), process analytical technology (PAT) integration, single-use continuous systems, regulatory pathways under ICH Q12 lifecycle management, and the cost-of-goods reductions achievable across mAb, cell-therapy and gene-therapy products. Discussion addresses the transition challenges from batch to continuous in legacy facilities, the regulatory considerations for global supply, continuous viral-vector production, the comparison of continuous vs batch for cell and gene therapies, and the workforce implications of process intensification.