Sterling Pharma Solutions Expands Deeside Site with £10m Investment
Sterling Pharma Solutions, a leading global contract development and manufacturing organisation, has announced the second phase of its expansion strategy at its Deeside, UK site.
With a more than £10 million investment, Sterling aims to increase its Good Manufacturing Practice (GMP) bioconjugation capacity, supporting the development of antibody-drug conjugates (ADCs).
This initiative will not only meet growing demand but will also address the recognised global shortage of ADC scale-up capacity, particularly as interest in ADCs expands beyond oncology applications.
Central to the expansion is the commissioning of a new 2,300-square-foot suite dedicated to clinical-scale ADC manufacturing. Equipped with reactors capable of handling up to 500 litres, the suite will more than double Sterling’s current production capacity, providing flexible, scalable solutions for customer projects as they progress through development stages.
The suite also includes a 1,400-square-foot Grade C cleanroom that is outfitted with both flexible and hard containment technologies to safely manage highly potent molecules, meeting occupational exposure limits as low as 0.01 micrograms per cubic metre – classified under occupational exposure band 5.
To enhance efficiency and safety, the facility will utilise flexible, single-use bioreactors. This setup reduces the potential for cross-contamination between manufacturing campaigns while ensuring more streamlined operations.
Furthermore, integrated automated transfer and control systems will further minimise the need for manual handling, contributing to a more efficient, secure manufacturing environment.
Supporting the new suite are Sterling’s existing GMP facilities, which include buffer and reagent preparation areas, waste disposal systems, a water-for-injection (WFI) generator, and state-of-the-art laboratories for analysis and quality control.
Additionally, the Deeside site will undergo an upgrade in its stability chamber capacity, allowing for enhanced storage and monitoring of final products to support customers’ regulatory compliance needs. The project is set for completion by early 2026.
The company’s Chief Operating Officer noted that ADCs are gaining attention as a versatile drug modality, increasingly being targeted at applications beyond oncology. They highlighted that the market’s expansion has led to a bottleneck in the development pipeline due to a global shortage of manufacturing capacity.
With this significant expansion, Sterling will not only double its production capabilities but also enhance its capacity to handle larger batch sizes and accommodate more complex manufacturing processes.
What’s more, this increased flexibility will enable Sterling to undertake a wider array of projects, supporting its long-term strategic goals for the Deeside facility.
In April 2023, the Deeside site achieved a Manufacturer’s Authorisation for Investigational Medicinal Products from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), permitting the manufacture of ADCs for clinical use under current Good Manufacturing Practices (cGMP).
This authorisation further strengthens Sterling’s ability to support innovators in the ADC field, reinforcing the facility’s credentials as a hub for specialised, high-quality manufacturing.
To conclude, as the ADC market grows, Sterling Pharma Solutions is positioning itself to meet the rising demand with cutting-edge facilities and expanded capacity.
The company’s ongoing investment in the Deeside site underscores its commitment to supporting the future of biopharmaceutical innovation and providing flexible, reliable manufacturing solutions to its global customer base.
News Credits: Sterling expands GMP ADC manufacturing capacity at Deeside
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