Abstract
Sterile fluid transfer between vessels is a key step in cell therapy manufacturing and requires specialised devices to maintain sterility of both vessels before, during and after the transfer. This review introduces two main types of devices for sterile fluid transfer in cell therapy manufacturing, namely single-use sterile connectors and tube welders. While these are excellent devices for infrequent moderate to large volume transfers, a new multiple-use aseptic connector may fill the gap for frequent small volume fluid transfers that are particularly important for autologous cell therapy manufacturing.
Highlights
Cell therapy is an advanced therapeutic that utilizes live cells in the treatment of ailments (Aijaz et al, 2018)
The manufacturing process is geared towards scale-up models similar to those used in biopharmaceutics, and is anticipated to generate production batch sizes of 200–2000 L (Pigeau et al, 2018)
Tubing to be welded must be the same size and material to ensure leak-free welds. In addition to these considerations, tube welding is associated with high capital cost and overhead cost as tube welders validated for cell manufacturing are expensive and require regular calibration and maintenance
Summary
Cell therapy is an advanced therapeutic that utilizes live cells in the treatment of ailments (Aijaz et al, 2018). The manufacturing process of cell therapy products is a permutation of several steps including but not limited to acquisition of live cells as starting material, expansion, modification, volume reduction, purification, formulation, fill and finish, storage, and shipping. For autologous cell therapy, starting material is obtained from the patient and the final cell therapy product is administered back to the same patient The manufacturing of this patient-specific product utilizes a scale-out model with small cell culture volumes of less than a few litres per product (Bartel et al, 2013).
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