Biopharma 4.0 for Biologics Manufacturing Under Pandemic Constraints

Biologics are the fastest growing molecular group in pharmaceutical therapies as supplying large most human-body like molecules with high efficacy at low doses and less side effects. Biopharma 4.0 relates to the fourth industrial revolution based on digitalization. Digitalization has reached biopharmaceutical industry along the whole development and value chain. Biologics manufacturing of such complex three-dimensional molecules in correct folding and glycosylation pattern for best bioavailability is still a challenge for world scale amount supply. As the variety of new entities vary recently quite broad from peptides, virus like particles, pDNA and mRNA to cell therapies new process design and development methods are needed to speed up robust product supply for patients. A sound theoretical basis is needed to utilize process modeling tools as digital twins for autonomous operation of manufacturing processes. Qualified operators are the rare resource bottleneck to guarantee product quality. Therefore, continuous biomanufacturing as well as the consequent application of the quality by design approachare key-enablers towards biopharma 4.0.