DKTK Core Facilities: GMP Facilities
In Tübingen, a GMP unit consisting of 6 clean air rooms for the manufacture of peptides is now available. The Core Facility “Peptide Vaccines” was specifically designed for rapid, small-scale GMP synthesis for personalized peptide vaccination and serve DKTK members as a Core Facility for the design and synthesis of mainly mutated or overexpressed tumor specific peptides identified via NGS and peptidomics. Tübinger peptide vaccines are already in use. Examples are the DKTK studies “iVacALL” or “NOA-16”. Within the EU project GAPVAC cancer patients are immunized with peptides from our Core Facility.
The Core Facility for the manufacturing of peptide vaccines consists of two areas
Area 1: “Wirkstoffpeptidlabor“, University of Tübingen, is located Auf der Morgenstelle 15, 72076 Tübingen, within the campus of the University. Here, peptides are manufactured as Active Pharmaceutical Ingredients (API) or Drug Substances (DS) under a GMP certificate issued by the local authorities, the Regierungspräsidium Tübingen.
Area 2: The GMP Centre (GMPZ) is located in the Center for Clinical Transfusion Medicine at Otfried-Müller-Str. 4/1, 72076 Tübingen, within the campus of the University Clinic. Here, peptide vaccines ready for use in patients are manufactured as Drug Products (DP) under a manufacturing authorization issued by the local authorities, the Regierungspräsidium Tübingen. In both areas, the peptides and vaccine peptides are manufactured by the staff of the Wirkstoffpeptidlabor under the direction of Prof. Dr. med Juliane Walz. The certification of the products is carried out for the active ingredient peptides by the head of quality assurance and for the clinical trial products by a qualified person according to §15 AMG.
You can find more information on the Website.
Prof. Dr. med Juliane Walz and Dr. Monika Denk