Sterling Pharma Solutions Expands Bioanalytical Method Development Capabilities

Sterling Pharma Solutions recently announced it has expanded its bioanalytical services offering at its Deeside, UK, site, which is the company’s dedicated facility for antibody-drug conjugates (ADCs). A new laboratory has been built and commissioned for its analytical services team, which will also grow as part of the investment. The team will provide support for existing and future customers’ ADC method development projects, as well as offering standalone bioanalytical services for companies developing biologic drug products and drug substances.

The new 210-sq-m laboratory has been equipped with a range of instruments for the development of release assays for antibodies and other biomolecules, including chromatographic, electrophoretic, ultraviolet and ELISA-based techniques.

The Deeside facility was granted a Manufacturer’s Authorization for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in June 2023, which allows the manufacture of ADCs for clinical use under current Good Manufacturing Practices (cGMP). Sterling supports the design and synthesis of chemical linkers and highly potent warheads for ADCs at its US sites in Wisconsin and North Carolina, before final conjugation steps are carried out at Deeside. Since the MHRA authorization, Sterling has manufactured GMP-quality ADC drug substance at the site, which has been delivered for use in clinical trials.

“The global demand for ADC development services has grown over recent years, and having been granted authorization for clinical-scale GMP manufacturing at Deeside, this has resulted in the need to segregate our analytical teams at the site into method development and quality control to undertake the specific complex testing required for these molecules,” said Stewart Mitchell, EVP and Site Head at Deeside. “The creation of a new, dedicated method development group with increased resources means that we can expand our services to support additional customers that are developing ADCs and other biomolecules with our scientific and analytical expertise.”

Sterling’s global network also includes its UK headquarters and manufacturing site in Cramlington, and an early phase chemical development facility in Newcastle upon Tyne, as well as a 111-acre site in Ringaskiddy, Ireland.

Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years’ experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specializing in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services.

Sterling has six facilities employing more than 1,350 people: its HQ in Dudley, Cramlington, UK and a site in Newcastle upon Tyne, UK; a European presence in Ringaskiddy, Co. Cork, Ireland; a dedicated bioconjugation and ADCs facility in Deeside, North Wales, UK; and two sites in the US, in Cary, North Carolina and Germantown, Wisconsin. Find out more.