Sterling Pharma Solutions, a Contract Development and Manufacturing Organisation (CDMO), has completed an additional large-scale GMP manufacturing suite at its dedicated bioconjugation facility in Deeside, UK. The expansion will double the facility’s manufacturing capacity and increase production scale to 500 litres.

The multi-million-pound investment includes a new analytical development laboratory and additional office space. The Deeside facility houses Sterling’s specialist bioconjugation teams supporting the discovery, development, scale-up and manufacturing of clinical Antibody-Drug Conjugates (ADCs) and other bioconjugates, including Antibody-Oligonucleotide Conjugates (AOCs), Antibody-Protein Conjugates (APCs) and radio-chelators.

The new GMP manufacturing suite features a 500-litre reactor and a 1,400-square-foot Grade C cleanroom, enabling the facility to undertake larger-scale GMP projects for pharmaceutical and biotechnology clients. The suite incorporates flexible and hard containment technologies for handling highly potent compounds. The facility can handle molecules with exposure limits as low as 0.05 ng/m³ (OEB 5), with processing carried out in single-use bioreactors.

Sterling has also expanded its analytical services capabilities with a new 3,400-square-foot laboratory. The facility increases HPLC and UPLC capacity and adds capabilities including UPLC-LC/MS, particle-size imaging using Bio-Techne MFI, protein stability characterisation, and automated plate-based ultrafiltration and diafiltration. The laboratory also includes a dedicated area for cell assay method development and analysis, supported by a SpectraMax iD3 multimode plate reader, Agilent NovoCyte flow cytometer and Thermo Evos M5000 fluorescence microscope.

Andrew Henderson, President EMEA and Chief Commercial Officer at Sterling Pharma Solutions, said the additional capacity marks a milestone in the development of the Deeside facility and its bioconjugation services. He said the expansion will enable Sterling to offer larger batch sizes and additional capacity, supporting programmes from development through Phase 3 and potentially commercial manufacturing.

Sterling also has specialist ADC capabilities at its Wisconsin, US facility for the development and manufacture of linker payloads. These capabilities operate in collaboration with the Deeside team, alongside partnerships covering antibody production and sterile fill-finish for drug products. Together, these capabilities enable Sterling to provide an end-to-end service for the clinical development and manufacturing of ADCs and other bioconjugates.

Sterling Pharma Solutions is a global CDMO with more than 55 years of experience in small-molecule API development and manufacturing. The company specialises in handling challenging chemistries and provides services to the pharmaceutical industry.