Abstract
Over the last several years, continuous manufacturing of pharmaceuticals has evolved from bulk APIs and solid oral dosages into the more complex realm of biologics. The development of continuous downstream processing techniques has allowed biologics manufacturing to realize the benefits (e.g., improved economics, more consistent quality) that come with continuous processing. If relevant processing techniques and principles are selected, the opportunity arises to develop continuous manufacturing designs for additional pharmaceutical products including liposomal drug formulations. Liposome manufacturing has some inherent aspects that make it favorable for a continuous process. Other aspects such as formulation refinement, materials of construction, and aseptic processing need development, but present an achievable challenge. This paper reviews the current state of continuous manufacturing technology applicable to liposomal drug product manufacturing and an assessment of the challenges and potential of this application.
Highlights
Continuous manufacturing is a processing concept whereby raw tinuous filtration by clearing the membrane surface with tangential fluid flow while alternating tangential flow (ATF) uses a cyclical backflush
tangential flow filtration (TFF) concentrates product through multisynthesis of active pharmaceutical ingredients (API) and ple passes of a recirculating loop while Single pass tangential flow filtration (SPTFF) concentrates in an generation of solid oral dosage forms.[1,2]
SPTFF enables product to be continuously fed to the economic advantages, as well as improved lower system hold-up volumes
Summary
Continuous manufacturing is a processing concept whereby raw tinuous filtration by clearing the membrane surface with tangential fluid flow while ATF uses a cyclical backflush. SPTFF enables product to be continuously fed to the economic advantages (lower capital expenditures, smaller facility unit operation or process step with the additional benefit of footprint, lower overall cost of goods [COG]), as well as improved lower system hold-up volumes. These efforts towards continuconsistency and quality of product.[1,2] As success and acceptance ous filtration operations are of particular interest when considering lessons learnt that may translate to applications in liposomal drug product formulations. Liposomal products are reformulations of compendial APIs meant to alleviate adverse clinical side effects and/or provide a more targeted delivery as compared to systemic dosages.[25,26] liposomal products have some elements of solid oral products (API manufacturing/sourcing/supply chain), some from biopharma (Mixing vessels, TFF, filtration, etc.) and some unique elements, which will be examined further here
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