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Aegerion Pharmaceuticals, Inc. (AEGR) Message Board

  • hankmanoo hankmanoo Aug 17, 2013 10:11 PM Flag

    Part IV - AAT orphan drug

    Consequently, the Cohn process is not able to meet worldwide demand. The
    complex steps and regulations required to collect donated plasma and complete the
    highly technical, innovative manufacturing processes that ultimately result in a final
    therapy result in long intervals between donation and final product release —
    between seven and nine months. This sets the production of plasma protein
    therapies apart from other biologics whose manufacturing processes are much
    more truncated and whose direct manufacturing costs are a significantly smaller
    portion of the overall cost. Hence the need for a platform that increases the
    amount of proteins extracted from plasma (yield) and identifies additional
    enhancements that can create even more effective therapies.
    4 ProMetic’s Plasma Process Improves Commercial Viability
    ProMetic Life Sciences (PLI) PPPSTM uses a chromatographic approach to plasma
    fractionation which significantly reduces losses incurred using the more
    conventional Cohn precipitation process. In PPPSTM, each protein is removed from
    the plasma by a specific ProMetic Mimetic Ligand™ adsorbent and subsequently
    purified in a side stream. The removal sequence has been optimised to give
    exceptionally high protein recoveries at unprecedented activity levels and allows
    the recovery of new biotherapeutics as they are discovered and identified.
    On Wednesday, PLI announced that the recovery yield for AAT achieved with its
    PPPS™ now represents a 220% improvement over the existing industry average
    compared with 170% previously reported.

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