History
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to date
More than 60 batches at 100 L scale were processed for clinical trials and validation studies.
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2003 - 2020
In total, 10 successful GMP-audits by local authorities and BfArM (valid GMP certificate up to 2021).
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2012 January
BIBITEC becomes a 100 % affiliate of Nordmark Arzneimittel GmbH & Co. KG.
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2008 June
BIBITEC becomes independent from NewLab with Dr. Jürgen Schumacher as the single shareholder.
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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.
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2004 Autumn
Initiation of clinical phase studies by our client STADA/Bioceuticals.
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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.
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2003 August
BIBITEC becomes a 100% subsidiary of NewLab BioQuality AG
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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