Sterling Pharma Solutions Bolsters ADC Capabilities with $3M Investment

• Sterling Pharma Solutions invests $3 million in its Germantown, WI facility.

• New GMP suite with advanced containment and processing capabilities installed.

Sterling Pharma Solutions has announced a significant investment to enhance its antibody-drug conjugate (ADC) contract development and manufacturing services. The $3 million investment at the Germantown, WI facility aims to expand the company’s integrated ADC capabilities, marking a substantial step in Sterling’s growth strategy.

The investment has facilitated the commissioning of a dedicated Good Manufacturing Practice (GMP) suite. This suite features a state-of-the-art modular isolator, enabling containment levels of less than 1 nanogram per cubic meter. The isolator’s design allows for toxin linker manufacturing on a kilogram scale, suitable for both clinical and commercial production.

Sterling’s expansion includes the installation of additional isolator modules for automated flash and high-pressure chromatography, catering to various phase conditions and in-process product analysis. A lyophilisation module for large-scale batches is also being commissioned, rounding out the suite’s capabilities for seamless, integrated processing.

This development has led to the creation of new scientific roles and the appointment of a dedicated industrial hygienist to oversee containment operations. The Germantown site is also recognized as Sterling’s global center of excellence for handling and manufacturing highly potent APIs (HPAPIs).

Chad Telgenhof, Sterling’s Chief Commercial Officer, highlighted the strategic importance of the investment: “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.” He further emphasized the suite’s specialized technologies, designed to facilitate the efficient transfer of toxin-linker molecules to Sterling’s UK facility for final-phase GMP conjugations of ADC drugs. The move underscores Sterling’s commitment to advancing contract manufacturing and supporting the pharmaceutical industry’s evolving needs.