Manufacturing and Bioprocessing – Biomolecular
2019 PharmSci 360
With several recent FDA approvals and a strong drug pipeline, gene therapy is coming of age. With this comes the requirement to ensure that there are robust manufacturing processes in place in order to scale with demand and to make these therapies readily accessible to those who need them. However, current manufacturing processes for gene therapies have often been developed with limited scalability in mind and large shifts in technology have to take place to enable industrialization. This also has to be done while keeping costs in mind.
Application of continuous bioprocessing is in its infancy in the field of biologics and to date has only been applied to the field of monoclonal antibodies. It has the potential to significantly improve the economics of making biologics. Here we investigate the application of continuous technologies to the manufacture of viral vectors for gene therapy particularly in the area of chromatography.