Sterling expands HPAPI capabilities to further strengthen integrated ADC services

30th May 2024

Sterling Pharma Solutions, a global contract development and manufacturing organisation, today announced a $3 million investment at its Germantown, Wisconsin facility, to expand its integrated antibody-drug conjugate (ADC) development and manufacturing capabilities. Sterling 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 nanogram per cubic metre.

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 lyophilisation of up to 30-litre batches at -85°C, is currently being commissioned, completing the suite’s capability to undertake integrated, seamless processing.

The expansion has led to the recruitment of additional scientists, in addition to the appointment of a full-time industrial hygienist to monitor all activities and containment operations at the site, which is also Sterling’s global centre 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 programmes through the clinical phase, towards commercial launch,” said Chad Telgenhof, Sterling’s Chief Commercial Officer. “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.”

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 United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), allowing it to manufacture ADCs for clinical use.

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