Rethinking manufacturing of virus-based therapies

Current biopharmaceutical manufacturing processes are still governed by iterative try-and-error strategies, high analytical costs, and the inability to make timely decisions on critical process parameters. In particular for complex biologicals, such as therapeutic viruses, this lack of scalable, standardized, cost-efficient, yet virus-tailored production processes is a major barrier to a broader clinical adoption. To address this challenge, more predictive adaptive production strategies are needed. As solution, our integrated process development approach comprises iterative, interconnected USP and DSP workflows with orthogonal virus-cell-analytics and targeted bioinformatics to enable scalable, high-density cell manufacturing and virus purification, ultimately allowing an enhanced preclinical to clinical transition rate.