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Sterilizing Filtration in Liposomal Formulations

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Resumo:Sterilization is a crucial step in the manufacturing of liposomal formulations that are intended for parenteral administration. Among the various sterilisation methods available, filtration is one of the most commonly employed techniques for achieving sterility in products that cannot be terminally sterilized. The filtration process is performed under aseptic conditions using sterilizing-grade filters with a pore size of 0.22 µm, which retain particles larger than 200 nm while allowing liposomes smaller than 200 nm to pass through. To meet regulatory standards, such as those defined by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the most suitable filter materials should be selected and validated along with the filtration process, with a set of sterility tests. Moreover, integrity tests, including forward flow and bubble point, are crucial to ensure that the filter assembly remains intact and operational throughout the process. Overall, these tests are critical for guaranteeing minimal degradation of the liposomes and maintaining product integrity, purity, and therapeutic efficacy.One of the great challenges in sterile filtration is achieving a balance between a product free of viable microorganisms without altering its physico-chemical properties. Fouling and contamination may occur, impacting the physical stability of liposomes and potentially affecting particle size, shape, or encapsulation efficiency. Therefore, critical process parameters, such as pressure and flow rate, must be optimized to minimize shear stress, preserving liposome structure and function. Optimization can also involve improving the upstream process, focusing on establishing precise control of particle size distribution and minimizing microbial contamination, thereby reducing the risk of associated issues.Given the limited studies and published guidelines on such a critical step in the manufacturing process, this work aims to shed light on this unexplored area by comprehensively reviewing the available literature and proposing a systematic approach to optimize sterilizing filtration operational parameters. Additionally, it presents a practical case study illustrating some of the challenges encountered during large-scale sterilizing filtration and reinforcing the need for effective control strategies.
Autores principais:Lopes, Diana Maria Lopes e
Assunto:Sterilizing filtration Liposomes Manufacturing process Sterility Membrane filters Filtração esterilizante Lipossomas Processo de fabrico Esterilidade Filtros de membrana
Ano:2025
País:Portugal
Tipo de documento:dissertação de mestrado
Tipo de acesso:acesso embargado
Instituição associada:Universidade de Coimbra
Idioma:inglês
Origem:Estudo Geral - Universidade de Coimbra

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