Potential of Continuous Manufacturing for Liposomal Drug Products. Issue 2 (11th June 2018)

• Record Type: Journal Article
• Authors: Worsham, Robert D.; Thomas, Vaughan; Farid, Suzanne S.
• Is Part Of: Biotechnology journal. Volume 14:Issue 2(2019)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2018-06-11
• Subjects: aseptic processing -- continuous manufacturing -- liposomes -- single‐use -- tangential flow filtration (TFF); Biotechnology -- Periodicals; 660.605
• DOI: 10.1002/biot.201700740
• Languages: English
• ISSNs: 1860-6768

Abstract

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. 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.