Increasing requirements for higher productivity and efficiency in the manufacture of biopharmaceuticals are providing the impetus for the adoption of single-use disposables in the biomanufacturing industry.
Over the last couple of years, interest has been growing in the use of pre-packed disposable chromatography columns and in the use of disposable process fluid contact pathways.Factors influencing this growth include the increasing number of monoclonal antibodies, novel proteins and biosimilars that are in development and clinical trials. Many of these products are being manufactured at relatively small-scale in multi-product facilities where measures to prevent the risk of cross-contamination of products is a high priority. The adoption of single use systems provides an effective assurance in this regard.
Downstream technology solution providers have responded to this need by providing pre-packed disposable chromatography columns, which are often used for multiple cycles before column replacement. These columns facilitate rapid change overs for different products and offer increased flexibility for facility design and operation. Most major suppliers offer pre-packed column options while various hardware manufacturers have aligned to provide column packing services using off-the-shelf chromatography media and columns of their own design.
More recently, another option for the disposable single-use column has been introduced by Prometic Bioseparations Ltd. The Evolve™ range of columns (developed in conjunction with Delta Precision Ltd) have a disposable (and/or re-cycle able) process fluid contact pathway housed in a re-usable outer column. This concept is analogous to the accepted approach of a disposable plastic bag liner contained within a re-usable hard outer container.
The Evolve™ columns are available in various dimensions, can be used in packed bed volumes ranging from 2L to 25L and retain the traditional axial column design familiar to most chromatographers. This versatile column range is applicable for use in research & development, process development and for small-scale clinical manufacturing. The Evolve™ columns can be provided empty so the user can pack with their resin of choice or provided ready-packed with Prometic Bioseparations' own chromatography media. Column refresh kits are also available so the inner liner can be changed and the original column outer re-used. This approach avoids the requirement and additional expense of dedicated columns for individual products as only the liner and column packing need to be changed.
Comparison of published prices indicates the Evolve™ column refresh kits are significantly less expensive (50% - 75% price reduction) compared to the price of equivalent (unpacked) fixed-volume disposable columns offered by other vendors. Consequently, the Evolve™ columns provide a significant benefit to companies who operate multi-product facilities and who routinely perform short production campaigns at relatively small-scale.