• to date

    More than 60 batches at 100 L scale were processed for clinical trials and validation studies.

  • 2003 - 2020

    In total, 10 successful GMP-audits by local authorities and BfArM (valid GMP certificate up to 2021).

  • 2012 January

    BIBITEC becomes a 100 % affiliate of Nordmark Arzneimittel GmbH & Co. KG.

  • 2008 June

    BIBITEC becomes independent from NewLab with Dr. Jürgen Schumacher as the single shareholder.

  • 2007 December

    STADA/Bioceuticals recieved the approval for Erythropoietin-zeta by the EU-Commission for the treatment of anaemia associated with cronic renal failure and chemotherapy.
    BIBITEC gains a manufacturing authorisation for the production of active pharmaceutical ingredients derived from eucaryotic cell lines for use in human drug products intended for clinical trials phase I - III.

  • 2007 August

    Clean rooms class C at the production site in Bielefeld are in operation.

  • 2004 Autumn

    Initiation of clinical phase studies by our client STADA/Bioceuticals.

  • 2003 August

    Approved and licensed by the district of Detmold and the BfArM for the production of an API under cGMP for production of pharmaceuticals.

  • 2003 August

    BIBITEC becomes a 100% subsidiary of NewLab BioQuality AG

  • 2001 Foundation

    BIBITEC was founded as a spin-off from the Institute of Cell Culture Technology; University of Bielefeld.

    Founder: Prof. Dr.-Ing J. Lehmann (former Head of the Institute), Prof. Dr. D. Lütkemeyer, Prof. Dr. med H. M. Schulte, Dr. J. Schumacher