ABX advanced biochemical compounds GmbH
Stephanie Ziesche has over 14 years of experience in the pharmaceutical and biochemical industries, currently serving as the Manager of Radiopharmacy and Project Lead at ABX advanced biochemical compounds GmbH since July 2009. In this role, Stephanie Ziesche oversees the establishment of Manufacturing Authorizations for radiopharmaceuticals and manages the transfer of products from development to routine GMP production. Additionally, as the Deputy Manager of the Quality Assurance Department, Stephanie Ziesche is responsible for maintaining and advancing the company’s Quality Assurance System, which includes batch record reviews and the release of GMP-grade products. Prior to joining ABX, Stephanie Ziesche worked at Roche Pharma from July 2007 to June 2009 in the Production Department, focusing on the fermentation of monoclonal antibodies and managing Quality Assurance aspects.
ABX advanced biochemical compounds GmbH
ABX advanced biochemical compounds is a global frontrunner in radiopharmaceuticals, with a focus on positron emission tomography (PET) tracers. We develop and produce all compounds and components for any kind of radiotracer – from PET and SPECT precursors, PET reagent kits and cassettes, to complete radiopharmaceutical drug production in GMP environment. Based in Radeberg, Germany, and founded in 1997, our team of more than 350 employees is specialised in custom synthesis and manufacturing of precursors and peptides according to GMP for active pharmaceutical ingredients. Thanks to our expertise combined with bleeding edge equipment, we reach highest research, production, and quality standards. For example, we operate a hot lab for R&D of new radiopharmaceutical kits and cassettes for our own product portfolio and in cooperation with pharmaceutical companies. Our extensive laboratory space enables us to perform stability studies of our products and in-house sterility testing of radioactive pharmaceuticals. Thanks to our production of aseptic excipients and sterile disposables, we are largely independent from external sourcing. We are also authorized producer of radiopharmaceutical drugs. Furthermore, we are experts in ASMFs, US-DMFs and technical documents for reagent kits, cassettes, PET and SPECT precursors.