Harmonized standards for your synthesis 

Development and GMP production of kit and cassette

Once a radiochemical production process is defined, we design a cassette (or disposable production set) and a reagent kit for all reagents, excipients, accessories and disposables needed. Specifications for all components are set according to your requirements while having in mind pharmaceutical demands. ABX offers its products in different quality levels – just according to your regulatory needs. Accordingly, complete product documentation like SHS, ASMF and/or DMF can be established.

We manufacture all cassettes, excipients, accessories and precursor fillings for your radiopharmaceutical in our dedicated GMP/ISO facility. In addition, all sterile disposables necessary for the manufacturing process (e.g. dispensing set) are produced in house which makes ABX completely independent from external suppliers securing the supply chain for your product.

Moreover, we have a special production unit that is dedicated on producing reagent kits and cassettes in smaller batch sizes and research grade quality. Each batch is produced in a clean production environment by trained employees – including an extensive batch documentation.