Sterling Pharma Solutions Expands GMP ADC Manufacturing Capacity at Deeside, UK

Sterling Pharma Solutions recently announced the second phase of an expansion strategy at its Deeside, UK, site to support antibody-drug conjugate (ADC) development, with a more than £10-million investment to increase GMP bioconjugation capacity. A new 2,300-sq-ft suite is being commissioned to allow clinical-scale manufacturing using reactors up to 500 liters in volume, which will more than double the site’s existing capacity, and offer flexible scale-up solutions for customer projects as they progress through development phases.

The new suite will include a 1,400-sq-ft Grade C cleanroom for ADC manufacturing, and will utilize both flexible and hard containment technologies to safely handle highly potent molecules with exposure limits down to 0.01 micrograms per cubic meter (occupational exposure band 5). Processing will be undertaken within flexible, single-use bioreactors to increase efficiency and eliminate the potential of cross contamination between manufacturing campaigns, with integrated automated transfer and control systems to reduce the need for manual operations.

Existing ancillary GMP facilities at the site for buffer and reagent preparation, waste disposal, water for injection (WFI) generation as well as analysis and quality control laboratories will support the new manufacturing suite. The site will also upgrade its stability chamber capacity for the storage and monitoring of final products to support customers’ regulatory needs, and completion of the project is expected in early 2026.

“The interest in ADCs as a drug modality is evolving, as innovators look to leverage their potential towards a number of targets beyond oncology, and there is a recognized global shortage of capacity for scale-up, resulting in a bottleneck in development,” said Andrew Henderson, Chief Operating Officer at Sterling Pharma Solutions. “This expansion will more than double our manufacturing capacity and allow us to handle both larger batch sizes and more complex processes, increasing our flexibility to undertake a wider number of projects. Sterling has an ongoing, long-term strategy for the facility at Deeside and this investment is the second step of that, to ensure we can meet the changing needs and demands of customers as the ADC market continues to grow.”

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 April 2023, which allows the manufacture of ADCs for clinical use under current Good Manufacturing Practices (cGMP).

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, specialising 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, NC, and Germantown, WI. Find out more.