Sterling Invests in Expansion of Integrated ADC Services

Global contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, announced on May 30, 2024 that it has invested $3 million into expanding its integrated antibody-drug conjugate (ADC) development and manufacturing capabilities in its Germantown, Wis. facility in the United States (1).

With the funds, a dedicated good manufacturing practice (GMP) suite will be built at the Germantown site, which will include the installation of a modular isolator that has containment capabilities down to less than one nanogram per cubic meter. Additionally, both clinical and commercial production will be possible from the site as the isolator has the capacity to perform toxin linker manufacturing up to kilogram scale. It will also be possible to weigh, dispense, and dissolve reagents easily within the fully contained environment of the isolator.

Other isolator modules are being installed for flash and high-pressure chromatography processes and for in-process analysis of products. Furthermore, a lyophilization module that is suitable for 30 L batches at -85 ºC has been commissioned.

“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, chief commercial officer of Sterling, in a press release (1). “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 [United Kingdom], in parallel, for the development and final-phase GMP conjugations of ADC drugs.”

In April 2023, Sterling’s Deeside facility in the UK was granted a Manufacturer’s Authorization for Investigational Medicinal Products from the Medicines and Healthcare products Regulatory Agency (MHRA) (2). This license allows Sterling to manufacture ADCs for clinical use at Deeside.

Sterling acquired the site in April 2021 and has invested in its expansion to develop the scientific and analytical teams, install a new water for injection plant, and establish bioconjugation and ADC manufacturing capabilities.

“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,” said Kevin Cook, chief executive officer at Sterling, in a press release (2). “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.”

The Deeside and Germantown sites work in parallel, providing services to develop and manufacture ADC drug molecules.

References

1. Sterling Pharma Solutions. Sterling Pharma Solutions Expands HPAPI Capabilities in Germantown, Wisconsin, Further Strengthening Integrated ADC Development and Manufacturing Services. Press Release, May 30, 2024.
2. Sterling Pharma Solutions. Sterling Granted MIA (IMP) License by MHRA for CGMP Antibody-Drug Conjugate Manufacturing at its Facility in Deeside, UK. Press Release, April 18, 2023.

Source: Sterling Pharma Solutions