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Jul 1, 2011 (Vol. 31, No. 13)

Alleviating Downstream Process Bottlenecks

Industry Demands Better Technologies as Logjams Weigh Down Manufacturing Operations

  • Downstream Areas for New Solutions

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    Biopharmaceutical manufacturers have serious concerns about inefficiencies in downstream processing and are looking to vendors to provide much-needed solutions. Sartorius Stedim Biotech is one of the companies introducing new products to reduce or eliminate the bottleneck that is hampering efficient bioprocessing.

    We evaluated new downstream technologies that respondents are considering currently, and compared this to last year’s responses. Of the 21 technologies identified, we found a strong and steadily growing interest in high-capacity resins and in-line buffer dilution systems. In addition, single-use filters are growing rapidly, as are disposable UF systems. The most rapid year-on-year growth has been in single-use prepacked columns.

    In terms of actually testing and implementing new downstream technologies, over half of the respondents reported having used or evaluated membrane-based technologies, and just under half have “developed processes with fewer steps”, but relatively few have switched to alternatives to protein A or have worked with continuous, e.g., simulated moving bed, chromatography.

    Desire for more and improved single-use/disposable equipment was a recurring theme in the study, with single-use equipment now widely recognized as providing cost savings, flexibility, and other benefits compared to fixed, usually stainless steel, equipment.

    In addition to increased demand for single-use/disposable equipment, there are a number of platform-level technological improvements that many companies are exploring to improve downstream processing, particularly purification. This includes:

    • simulated moving bed chromatography;
    • chromatography resins that are cheaper, faster-flowing, more selective, and have higher binding capacities;
    • novel separation methods, such as chromatography monoliths, involving casting media as needed as solid columns;
    • alternatives to protein A;
    • adoption of disposable protein A columns for antibody purification;
    • new and improved depth, ultrafiltration and membrane filters, including those capable of replacing more chromatography columns;
    • increased use of product-customized affinity purification media; and
    • improved modeling of separations at the molecular and process levels to enable better process predictability and optimization.

    The pendulum continues to swing toward resolving downstream bottlenecks, and the industry continues to invest in ways to improve its technologies. Some solutions may reside in improved upstream process development that shifts from improvements in cell culture and fermentation toward more purified targets in the supernatant. Others may present entirely novel alternatives to current technologies. At some point in the future, major issues in downstream bottlenecks will be resolved, and the pendulum will return to upstream and other areas of process improvement.



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