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.