Traditional biologics manufacturing often relies on batch or fed-batch processes. Continuous processing offers an alternative approach in which product is continuously harvested while the bioreactor operates for an extended period.
Continuous bioprocessing can offer high cell density, increased productivity, smaller facility footprint, potentially more consistent process conditions and improved manufacturing efficiency. Shilpa Biologicals describes proprietary continuous-process platforms for monoclonal antibodies, fusion proteins and glycoproteins.
In one published case study, Shilpa Biologicals developed an ATF-based perfusion process for a highly sialylated Fc fusion protein. The company reports that the approach achieved high cell density and titers with consistent sialylation while eliminating an additional depth-filtration step.
Continuous bioprocessing can be particularly valuable for complex biologics where productivity, product quality and process consistency must be balanced. Its successful implementation depends on appropriate process development, analytical monitoring and scale-up strategy.