Sterling said that it has commissioned a dedicated GMP suite at the site, which will incorporate the installation of a modular isolator with containment capabilities down to less than 1 ng/m³.

According to Sterling, the isolator has the capacity to undertake toxin linker manufacturing up to kilogram scale, allowing both clinical and commercial production, and facilitates weighing, dispensing and dissolving of reagents within a fully contained environment. Additional isolator modules for automated flash, and high-pressure chromatography under a range of normal and reverse-phase conditions, as well as in-process analysis of products have also been installed. A further module, which will allow lyophilization of up to 30-litre batches at -85°C, is currently being commissioned.

The Germantown facility is also Sterling’s global center of excellence for the handling and manufacturing of highly potent APIs (HPAPIs).

“This investment is a crucial step in Sterling’s ambition to provide a full range of services to support our clients’ ADC development projects and accelerate programs through the clinical phase, towards commercial launch,” said Chad Telgenhof, Sterling’s chief commercial officer. “The new suite has been specifically designed with specialized technologies to support the manufacture of toxin-linker molecules that can be efficiently transferred to our facility in Deeside, UK, in parallel, for the development and final-phase GMP conjugations of ADC drugs,” said Chad Telgenhof, Sterling’s chief commercial officer.