Streamlining Single-Use Assemblies In The Bulk-Fill Step Of Downstream Processing

Finding a universal single-use assembly for bulk filling

Single-use (SU) systems and components have become indispensable in the biopharmaceutical industry, where patient safety is paramount. Stringent safety regulations necessitate minimal contamination risk, making SU technology increasingly attractive. SU components offer advantages beyond contamination control, including enhanced process flexibility and reduced capital expenditure for contract manufacturing organizations (CMOs). These benefits stem from the elimination of cleaning validation and downtime associated with traditional reusable equipment.

Delve into the intricacies of SU components that are employed during the bulk-fill stage of downstream processing, including elements such as hoses, connectors, manifolds, tubing, and bags. While these components offer versatility, constructing a fully integrated SU assembly requires a comprehensive understanding of each component's function and compatibility. Review a standardized SU assembly for bulk-fill processing that aims to streamline the process and potentially improve efficiency for CMOs. Additionally, the paper discusses the ongoing exploration at Samsung Biologics to develop a range of sustainable SU assemblies tailored to the specific needs of a broader client base.