Conclusions
Continuous manufacturing designs for liposomal drug products will help meet the demand for these formulations, which are critical for future drug delivery options. Understanding what impacts these continuous manufacturing designs has benefit to their optimization. What is viewed to be a minor phenomenon in a batch process design could have significant impact to a continuous design. The deduction of an ethanol concentration-dependent rejection coefficient in the batch process has led to a greater understanding of how ethanol concentration will impact a continuous TFF/ILDF process. Ethanol reduces and limits hollow fiber permeability with the impact increasing with concentration. It was determined that by diluting the post-liposome formation bulk and reducing the initial ethanol concentration that fewer passes/stages of ILDF and less buffer would be needed to achieve target ethanol removal. In understanding this impact, continuous ILDF presents as a competitive alternative to the batch process that can be scaled at will.