CCE 0.00% 0.1¢ carnegie clean energy limited

c3 receives gmp approval from

  1. 1,523 Posts.
    Tuesday 6th July 2004, PERTH, AUSTRALIA: Clinical Cell Culture Ltd (C3, ASX: CCE) today
    announced that the Belgium Health Authorities have authorised Cambrex, C3’s European
    contract manufacturer, to manufacture CellSpray® and CellSpray® XP on behalf of C3. The
    authorisation represents manufacturing approval in accordance with Good Manufacturing
    Practice (GMP).
    GMP is the highest possible production standard for cell therapy products and represents the
    primary regulatory hurdle for several European countries as well as for the Australian market.
    C3 expects to launch CellSpray® XP (for burns up to 30%) to customers early in the 3rd quarter
    2004. The first patients will be treated shortly thereafter. In addition, the Company expects
    during the 3rd quarter 2004 to have finalised product validation for CellSpray®. Commercial
    sales for CellSpray® will commence soon thereafter.
    Troels Jordansen, CEO for C3 said, “We are delighted with the GMP approval. This marks an
    important commercial milestone for the Company and will allow C3 to launch CellSpray® in
    This has prompted C3 to consider relocating some of its corporate functions to its European
    office in England, allowing C3 to service and support the European market.
    Over the past 6 months we have maintained close contact with a number of leading European
    burn centres, all of whom are keen to begin treating patients with C3 products as soon as
    ABOUT C3
    Clinical Cell Culture (C3) is a publicly listed biomedical company that develops and distributes a
    number of tissue-engineered products for the treatment of wounds and other skin defects.
    Using proprietary tissue-culture/collection technology, C3 is able to provide innovative treatment
    solutions, using the patients own skin, to enhance healing rates, reduce scar formation and
    reintroduce pigmentation into the skin.
    The company’s lead products are CellSpray®, a suspension containing cultured skin cells from
    the patient for use in the treatment of major burns and scars, and ReCell®‚ a device that
    enables the collection of healthy skin cells for immediate application on damaged skin such as
    small burns, areas of pigment loss and scars. C3’s products have been used on more than
    1,600 patients to date.
    C3 is focused on further research and development. Pipeline products evolving from our R&D
    programme include EpiGrow®, an autologous skin derived fluid for the treatment of chronic
    wounds and SteriFast®, an end-point sterility diagnostic system that will allow testing of
    biological products within hours, compared to current technologies which can take several days. Page 1 of 3
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