GH Genhelix Receives GMP Approval
8/6/2013 8:51:32 AM
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August 6, 2013 -- GH Genhelix S.A. (GHL), a privately held company based in Leon, Spain, is pleased to announce that its single-use technology based facility has received EU GMP approval for the manufacturing of Biological APIs.
This milestone constitutes a major step forward in Genhelix’ history as Genhelix gains access to the main global biotech markets.
GHL’s exceptional team has made it possible in a record time of 12-months. They constitute the main pillar for an optimal performance in the upcoming projects and for the foreseeable future of Genhelix.
The approval of Genhelix fully single-use technology based plant with its Protoplant® manufacturing platform is the first of its kind in Spain and one of the very few worldwide.
The aforementioned technology significantly reduces the cross contamination risk while lowering the fixed expenditures in terms of initial investment and personnel, resulting in a 10-20% average reduction in the manufacturing cost compared to a traditional, stainless steel based facility.
The EU GMP approval ratifies GHL as a top-notch manufacturing facility for Biological APIs in the Biotech Sector at a Global Scale.
Genhelix is an independent Biopharmaceutical Group founded in 2006 in Leon, Spain. It is devoted to the Process Development and Manufacturing of Monoclonal Antibodies and other Biologics under GMP conditions in what is called a “one stop shop” CDMO. GHL covers all the activities ranging from the development of a Master Cell Bank to the GMP manufacturing for clinical trials and commercial scale.
Currently Genhelix is expanding its capacity in order to handle projects involving bigger manufacturing volumes with single-use technology as its cornerstone.
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