Batch Processing
The batch process for manufacturing liposomal drug product, as depicted
in Figure 1B, involves mixing/infusing streams of lipid solution and
amikacin solution at the crossflow point in an approximate 1:2 ratio.
The magnitude of these flow rates is dependent on the scale of the
process. The output of the crossflow point (“liposome mixture”) is fed
into a central vessel concurrently with the buffer solution. Constant
volume diafiltration (CVDF) is performed using a 50kDa GE hollow fiber
cartridge (UFP-500-E-85MSM) until six diavolumes have been processed.
The product is then concentrated through the hollow fiber membrane until
the retentate reaches 70mg/ml amikacin base.