Use of pre-packed columns in downstream chromatography has increased in response to the needs of multi-product facilities and initiatives focused on reducing change-over time. In particular, adopters of pre-packed columns have realized the following benefits:
- Quick and easy set-up
- Rapid change over (no column packing, unpacking, or cleaning validation)
- Operational flexibility for multi-product facilities
- Reduced capital expense
- Reduced operational cost
- Eliminate column packing issues
Replacing traditional self-packed glass or stainless steel columns, pre-packed columns are packed by experts in state of the art facilities and are delivered ready to use for GMP processing.
The ability of pre-packed column suppliers to focus their operations on column packing results in more consistently packed columns over time. This allows a bioprocessing facility to outsource column packing, a non-value added step for making therapeutic proteins, and no longer worry about column packing issues. This transfer of operational risk helps adopters of pre-packed columns to maintain leaner operations and focus on the most critical aspects of making and purifying therapeutic proteins.
As the industry evolves to incorporate continuous processing, pre-packed columns are a perfect fit for multi-column chromatography. Banks of multiple pre-packed columns can be delivered ready to run eliminating the need for multiple self-packed columns. In addition, the potential for pre-packed columns to be gamma sterilized provides a compelling value proposition for companies looking to implement multi-column chromatography.
OPUS® PRE-PACKED CHROMATOGRAPHY COLUMNS
OPUS® Pre-packed Chromatography Columns offer unparalleled flexibility in media choice, application and size. Applying the most advanced pre-packed chromatography column technology available today, OPUS® columns are ready-to-use alternatives to traditional self-packed columns. Manufactured following ISO 9001 quality manufacturing guidelines, each column comes with complete documentation for GMP use.
The OPUS® 45R and 60R columns feature an innovative unpacking port that allows for resin unpacking without loss in chromatographic performance. They are also the first pre-packed columns designed to meet the chromatography requirements of larger 1000L and 2000L disposable bioreactors
OPUS® PD Columns for process development are used for resin screening, chromatography process development, process validation including viral clearance, scale-up, and sample preparation.
OPUS® columns deliver the required flexibility for multi-use applications in downstream processing for monoclonal antibodies, recombinant proteins, or vaccines.
The results from a 10-cycle purification of a recombinant protein from E. coli show no substantial difference in run-run consistency and chromatographic performance is maintained over the course of many cycles.
Over 19% cost savings and up to 50% labor savings (~92 FTE hours) were achieved when using the OPUS® 60 column compared to traditional self-packed columns.
Glass column amortized over 20 campaigns, OPUS® column over 3 campaigns; 3 batches/campaign; 2 cycles/batch; no column repacks.
Substantial savings are realized because OPUS® columns offer the benefits that come with pre-packed disposable technology:
- No upfront capital expense
- Reduction of CIP and cross contamination
- Faster campaign turnaround time
- Operational excellence (reduce labor requirements)
Data presented are estimates and subject to change.
Use the OPUS® Calculator to find out how much you can save when using OPUS® columns in your specific application.