Article
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1. Time Savings
Elimination of the column packing step associated with column chromatography frees up specialized resources and saves time. Other time savings are also realized with the use of prepacked columns. For example, fewer procedures for column packing, validation, cleaning, and quality control (QC) testing are required. Column packing equipment and traditional columns themselves are not needed so there is no waiting for these to be available, and buffer preparations are reduced by removing packing steps. is also used, the connections, sensors, and cables are included with the flow path kit, saving time on skid preventative maintenance (PM). PM on a single-use production skid requires less than a day. In contrast, PM on a standard production skid is generally a 3-day process. Changeover is rapid, requires fewer production and QC resources, and a facility can eliminate non–value-added activities.
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2. Cost Savings
Prepacked columns offer cost savings by eliminating the need for manual column packing and validation, along with the associated materials, equipment, and labor required. This leads to reduced packing material consumption, such as resins and buffer, and eliminates the need for dedicated column packing areas and storage rooms, freeing up valuable space and simplifying suite design. When resin inventory is managed in a prepacked format, procurement of resin needed for column packing and backup resin quantities are no longer needed, reducing labor costs associated with resin handling and inventory management.
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3. Reliable Scheduling
Production processes that employ prepacked columns do not have to account for resin lead times, column packing, and possible column packing inconsistencies in the schedule. In addition, managing the supply of resins is transferred to the supplier, and fewer spare parts are required in inventory. These factors enable rapid changeover and more flexibility in a facility producing multiple biotherapeutics.
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4. Consistency
By outsourcing to a supplier specializing in column packing, the consistency of the packed bed is improved. Columns are packed with single resin lots in standard bed heights and diameters, providing optimized, consistent slurry and packing conditions. Columns are packed in a cleanroom, individual column release testing is performed, and each column is shipped with quality and performance documentation. A complete documentation package along with presanitization, reduction of bioburden, and prevention of cross-contamination combined with packing consistency can reduce QC full-time equivalent expenditures and simplify approvals. Column consistency across facilities is an added benefit when a biotherapeutic is produced at multiple sites.
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5. Flexibility
The use of prepacked columns facilitates flexible scheduling, rapid process turnover, and simplifies the addition of a new biotherapeutic to a facility. Process developers can choose from a wider range of resins as expertise in packing a novel resin and development of resin cleaning and other procedures may not be required. Virtually any Many resins can be procured in a prepacked format, thus providing developers more flexibility in adopting new separation technologies and reducing the limitations inherent in the industry concept of “platform” resins.
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6. Operational Excellence
The transfer of operational risk to external suppliers aligns with initiatives for leaner operations and allows end users to focus on more critical aspects of purifying therapeutic proteins. Indeed, if the prepacked columns are supplied by the resin manufacturer, lead time may be shorter as resin is readily available with the added benefit of a single source for technical support. Procurement efficiency is also realized with reduced resin inventories, elimination of resin lot matching, and maintaining spare parts for columns and standard skids. Regardless, the benefits of a leaner, more flexible operation have led to the wide adoption of prepacked columns.
Summary
Prepacked columns have become a viable approach for commercial manufacturing due to their operational benefits. Now routinely used by CMOs and innovators to produce clinical phase materials, prepacked columns enable substantial time savings and lower capital investment by eliminating the need for packing in process operations while providing the high performance, consistency, and reliability demanded by lean manufacturing environments.
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References
Rader RA and Langer E (2018). Single-use bioprocessing equipment trends and adoption by CMOs. BioPharm International 31, 10–13.
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