Image Credit: Sterling Pharma Solutions Website
Sterling Pharma Solutions, a contract development and manufacturing organization (CDMO), is financially committing $3 million toward its Germantown, WI plant, in order to grow its integrated antibody-drug conjugate (ADC) development and manufacturing services.1
This expansion project opens up the door for the recruitment of more scientists, alongside the hiring of a full-time industrial hygienist who will oversee the site’s activities and containment operations. The site also happens to be the home of the company’s global center of excellence for the handling and manufacturing of highly potent APIs (HPAPIs).
As a result, the CDMO has designed a dedicated good manufacturing practice (GMP) suite at the facility, where a modular isolator with containment capabilities down to less than 1 nanogram per cubic meter (35 cubic feet) is expected to be installed.
The aforementioned isolator has the capability to handle toxin linker manufacturing up to kilogram scale, signifying that can endure both clinical and commercial production; its purpose is to make the weighing, dispensing and dissolving of reagents much easier, especially in a “fully contained” atmosphere.
There are also other isolator modules that have been installed in the facility, and these are specifically for automated flash, and high-pressure chromatography. In-process analysis of products have also been installed. Another module—that is currently in production—is capable of allowing for the lyophilization of up to 30-liter batches at -85°C.
“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.”
The Deeside plant that Telgenhof alluded to was given Manufacturer’s Authorization for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), which grants it permission to manufacture ADCs for clinical use.2 Back when the CDMO acquired ADC Biotechnology in April 2021, it was also given ADC Biotechnology’s 6,500 square-meter site (approximately 70,000 square feet). Since then, it has heavily in facility expansion via bioconjugation, and it made a conscious effort to further develop its analytical and scientific teams.
“The ADC facility in Deeside has over 12 years’ experience in technical development services for the industry. The granting of this license marks a major milestone for Sterling, with the company now able to integrate development and clinical manufacturing services across our network to support ADC innovators in bringing new therapies to the market,” noted Kevin Cook, Sterling’s CEO. “Our decision to expand the business in 2021 to include ADCs was strategic, to broaden our chemistry services offering to include specialized bioconjugation capabilities, and has led to a number of partnerships in this area with drug developers. Our plan is to continue investment at Deeside as customer demand for these services increases to grow the business further.”
References
1. Sterling expands HPAPI capabilities to further strengthen integrated ADC services. Sterling Pharma Solutions. May 30, 2024. Accessed May 31, 2024. https://www.sterlingpharmasolutions.com/articles/sterling-pharma-solutions-expands-hpapi-capabilities-in-germantown/
2. Sterling Granted MIA (IMP) License by MHRA for cGMP Antibody-Drug Conjugate Manufacturing at its Facility in Deeside, UK. Sterling Pharma Solutions. April 18, 2023. Accessed May 31, 2024. https://www.sterlingpharmasolutions.com/articles/sterling-pharma-solutions-granted-license-by-mhra-for-cgmp-antibody-drug-conjugate-manufacturing/