ABX history is tightly connected with GMP production. Shortly after founding ABX GMP production started to offer easy to use kits, cassettes, ancillaries, precursors and precursor fillings for radiopharmaceutical production of our costumers. In close cooperation with other departments or with costumers, new products are transferred and established in GMP/ISO environment. Accompanying to our GMP products documents like SHS, ASMF and/or DMF can be established to support the regulatory needs of our costumers.
Since its start in 2007, the radiochemistry department of ABX was continually expanded with hot cells and radiochemical quality control devices. In 2015, a new laboratory building was put into operation, extending the number of hot cells being exclusively used for radiochemical research. The installation of a new cyclotron (10 MeV, 50 µA) allows a daily production of fluorine-18 and carbon-11. Furthermore, we work with gallium-68, lutetium-177 and yttrium-90 on a regular basis.
Moreover, we have a broad selection of the most common radiotracer synthesizers at our disposal. This allows us to develop quickly automated syntheses for new radiotracers on most available synthesizer modules.
In 2018, ABX has put into operation an additional radiochemical lab for GMP compliant synthesis of radiotracers. Having an aseptic filling line and an in-house sterility testing, we provide optimal conditions for custom manufacturing of any radiotracer or radiopharmaceutical.
ABX department Medicinal Chemistry is located in Heidestrasse 70 Building 211 in Radeberg. Here we have been constructing our new laboratories clean rooms and offices with a total area of more than 2000 m2 to cope with the increasing demand.
All laboratories are equipped according to the current standards for syntheses, analyses and cGMP-production according to the ICH guideline for substances Q7A. Our facilities are approved by the German authorities and production can be performed in clean rooms class C and D to minimize bioburden.
Laboratories for small scale reactions and kilo-labs are equipped with standard glass reaction vessels up to 20 L. Syntheses can be performed within temperatures ranging from – 100 ° C to + 250 ° C and pressure can be up to 100 bar and vacuum can be down to 10-3 mbar. All reactions can also be performed under inert gas atmosphere. Purification of products is done by column chromatography, preparative HPLC, recrystallization and/or destillation.