Prepacked chromatography columns: the new trend in biopharmaceutical manufacturing

In the interest of cutting costs, reducing production time and increasing plant flexibility, the biopharmaceutical industry has made a marked shift toward single-use manufacturing. One of the fastest growing segments of single-use technologies are chromatography membrane adsorbers and pre-packed, chromatography columns which are an ideal fit for preclinical and clinical stage MAb production and vaccine manufacturing. These processes require quick turnaround times and rigorous validation.

Recognizing this opportunity, Merck has developed the Chromabolt™ column, a family of pre-packed and ready-to-use chromatography columns. Chromabolt™ pre-packed columns will launch in September 2013 with Eshmuno® S, Fractogel® TMAE HiCap and Fractogel® SO3 resins as well as in varying sizes ranging from 10 cm to 32 cm column diameter to meet customer process and scale requirements. Additional Ion Exchange and Affinity Resins will be available in the future.

Intermediate to large scale column packing is considered a highly specialized skill in the pharmaceutical industry due to various idiosyncrasies associated with packing different resins. It is extremely difficult to pack beds with reproducible performance and specifications, which is further driving the need for pre-packed columns. Chromabolt™ has been intelligently designed with our customers to ensure that it can be used ergonomically and that customers can easily use it within their manufacturing facilities. It does not require additional trolleys or hardware and can be moved by one person and attached to any chromatography skid.

With the introduction of this innovative product, we can now offer high quality columns that are reproducible, scalable and provide drug manufacturers with significant cost and time savings.

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