Cell and gene therapies are transforming the modern healthcare paradigm, giving hope to patients suffering from a variety of diseases from ophthalmology to oncology.
The manufacturing of these products, personalized (autologous) or off-the-shelf (allogeneic), is currently associated with high cost of goods. The fill & finish, as one of the last steps in the manufacturing process, is identified as critical and strategic in order to timely deliver the treatment to the patients. Moreover, to preserve their quality attributes, the cell therapy, gene therapy and elements of their production, are most often cryopreserved. This fact imposes particular requirements on the logistics, the primary container and the overall fill and finish process.
To avoid important bottlenecks at later phases, the appropriate choice of GMP-compliant technology shall be done as early as possible.