Sterling Pharma Solutions Invests £10M in Deeside Expansion for ADC Manufacturing

• Sterling Pharma Solutions invests over £10 million in Deeside facility to expand ADC manufacturing.

• New bioconjugation suite will double the facility’s capacity, supporting clinical-scale ADC projects.

Sterling Pharma Solutions, a global contract development and manufacturing organisation (CDMO), has initiated the second phase of its expansion strategy at its Deeside, UK, facility with an investment exceeding £10 million. The expansion includes a new 2,300-square-foot suite aimed at bolstering Good Manufacturing Practice (GMP) bioconjugation capacity for antibody-drug conjugates (ADCs). This new suite will double the site’s capacity and allow for the production of clinical-scale ADCs using reactors up to 500 litres, supporting flexible scale-up options across development stages.

The Deeside facility expansion features a 1,400-square-foot Grade C cleanroom equipped for safe ADC manufacturing, employing both flexible and hard containment technologies for potent molecules with low exposure limits. The suite will include single-use bioreactors to improve manufacturing efficiency, integrating automated transfer and control systems to minimise manual handling, which enhances both safety and process consistency.

Supporting infrastructure at the site, such as ancillary GMP facilities for buffer and reagent preparation, waste management, and water for injection (WFI) production, will back the expanded bioconjugation capabilities. Quality control labs and upgraded stability chambers will allow for advanced product storage, aiding regulatory compliance. The project is on track for completion by early 2026.

Andrew Henderson, Chief Operating Officer at Sterling Pharma Solutions, highlighted the expanding interest in ADCs across therapeutic areas and the global shortage in ADC manufacturing capacity. “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,” said Henderson. He added that Sterling’s investment is part of a long-term strategy to meet evolving market needs.

The Deeside site, which obtained a Manufacturer’s Authorisation for Investigational Medicinal Products from the MHRA in April 2023, is now authorised to manufacture ADCs under cGMP for clinical applications.

Read about ADC Antibody Drug Conjugates CDMO Market 2024 Here.