Sterling Pharma Solutions, has invested USD $3m into its Germantown, Wisconsin facility to expand its integrated antibody-drug conjugate (ADC) development and manufacturing capabilities.
The global contract development and manufacturing organisation (CDMO) 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 1ng/m3.
Modular isolators for every step of ADC manufacturing
Sterling’s novel isolator has the capacity to undertake toxin linker manufacturing up to the kilogram scale, allowing both clinical and commercial production, as well as facilitating weighing, dispensing and dissolving of reagents within a fully contained environment.
Additional isolator modules for automated high-pressure chromatography under a range of normal and reverse-phase conditions have also been installed.
A further module, which will allow lyophilisation of up to 30 L batches at -85 °C, is currently being commissioned, completing the suite’s capability to undertake integrated, seamless processing.
Expanding the team
The expansion has led to the recruitment of additional scientists, as well as the appointment of a full-time industrial hygienist to monitor all activities and containment operations at the site.
The facility also acts as Sterling’s global centre of excellence for the handling and manufacturing of highly potent APIs (HPAPIs).
The new suite has been specifically designed with specialised 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 Sterling’s Chief Commercial Officer, Chad Telgenhof.
In April 2023, Sterling’s Deeside site, which is dedicated to ADC development, was granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the UK's Medicines and Healthcare products Regulatory Agency (MHRA), allowing it to manufacture ADCs for clinical use.