Operational Advantages
Offering substantial cost savings, pre-packed columns eliminate the need for manual column packing and validation, reducing the material and labour costs associated with traditional column chromatography processes. Pre-packed columns also eliminate the need for dedicated column packing areas, freeing up valuable space in the production facility. This allows for simpler suite designs and improved overall efficiency. Furthermore, by managing resin inventory in a pre-packed format, biopharmaceutical companies can reduce labour costs associated with resin handling and inventory management.
Another benefit of pre-packed columns is the increased flexibility they provide by allowing for rapid process turnover, a particularly useful feature in a facility producing multiple biotherapeutics. Process developers can choose from a wider range of resins, as expertise in packing a novel resin may not be required. Many resins can be procured in a pre-packed format, thus providing developers more flexibility in adopting new separation technologies and reducing the limitations inherent in the industry concept of "platform" resins.
Improving consistency, pre-packed columns are packed with single resin lots in standard bed heights and diameters, providing optimised, consistent slurry and packing conditions. In addition to pre-sanitisation, reduction of bioburden, and prevention of cross-contamination, each column is shipped with quality and performance documentation, and individual column release testing is performed. This can reduce QC full-time equivalent expenditures and simplify approvals. Moreover, column consistency across facilities is an added benefit when a biotherapeutic is produced at multiple sites.
By outsourcing the column packing step to a resin supplier specialising in column packing under optimal conditions, the risk of inconsistencies in the packed bed is reduced. This allows end-users to focus on more critical aspects of purifying therapeutic proteins. The use of pre-packed columns can also reduce procurement inefficiencies, such as resin inventories, elimination of resin lot matching, and maintenance of spare parts for columns and standard skids. The availability of pre-packed columns from resin manufacturers can also reduce lead times as the resin is readily available with the added benefit of a single source for technical support.
In recent years, pre-packed columns have emerged as a game-changing solution for commercial manufacturing. They have quickly become a viable approach for commercial manufacturing and are now routinely used by contract manufacturing organisations (CMOs) and innovators to produce biotherapeutics. With their ability to streamline operations, reduce costs, and improve quality, pre-packed columns represent a significant step forward for the biopharmaceutical industry. As such, they are likely to continue to play a major role in the future of biotherapeutic manufacturingpre packed colums