Contract development and manufacturing organisation (CDMO) Sterling Pharma Solutions completed an additional large-scale GMP manufacturing suite at its dedicated bioconjugation facility in Deeside, UK. The expansion will double the site’s manufacturing capacity while increasing its production scale to 500 litres. The multi-million-pound investment strengthens Sterling’s ability to support the growing demand for antibody-drug conjugates (ADCs) and other advanced bioconjugates.
Expanded Facility Supports Large-Scale GMP Manufacturing
The expanded Deeside facility houses Sterling’s specialist bioconjugation teams, which support discovery, development, scale-up and clinical manufacturing of ADCs and other bioconjugates. These include antibody-oligonucleotide conjugates (AOCs), antibody-protein conjugates (APCs) and radio-chelators. The GMP suite features a 500-litre reactor and a 1,400-square-foot Grade C cleanroom. Consequently, the facility can now support larger GMP projects for pharmaceutical and biotechnology customers. Moreover, the suite combines flexible and hard containment technologies to enable the safe handling of highly potent compounds. The Deeside facility can process molecules with exposure limits as low as 0.05 ng/m³ (OEB 5), with processing carried out using single-use bioreactors.
New Analytical Laboratory Expands Testing Capabilities
Alongside the GMP expansion, Sterling has established a new 3,400-square-foot analytical services laboratory at the Deeside facility. The laboratory adds both capacity and new analytical capabilities to support bioconjugation development and manufacturing. The facility increases HPLC and UPLC capacity and introduces several advanced analytical technologies, including:
UPLC-LC/MS for advanced analytical characterisation.
Bio-Techne MFI for particle-size imaging.
Protein stability characterisation capabilities.
Automated, plate-based ultrafiltration and diafiltration.
Dedicated facilities for cell assay method development and analysis.
The laboratory also features a SpectraMax iD3 multimode plate reader, Agilent NovoCyte flow cytometer and Thermo EVOS M5000 fluorescence microscope, further strengthening Sterling’s analytical capabilities.
Larger Batch Sizes Support Clinical Development
Andrew Henderson, President EMEA and Chief Commercial Officer, Sterling Pharma Solutions, said the additional capacity represents a milestone in the development of the Deeside facility and its bioconjugation services. The expanded capabilities respond to both customer requirements and growing market demand. Sterling can now offer greater manufacturing capacity and larger batch sizes, enabling customers to progress projects from development through Phase III and ultimately commercial manufacturing. The additional capacity is also immediately available to customers.
End-to-End ADC Manufacturing Support
Sterling further strengthens its ADC capabilities through its Wisconsin, US facility, which specialises in the development and manufacture of linker-payloads. The US team works closely with the Deeside bioconjugation team to support ADC development and manufacturing. In addition, Sterling maintains strategic partnerships covering antibody production and sterile fill-finish (drug product). As a result, the company can provide pharmaceutical and biotechnology customers with an end-to-end service for the clinical development and manufacturing of ADCs and other bioconjugates.
Strengthening ADC Manufacturing Capabilities
With the Deeside expansion, Sterling Pharma Solutions is increasing its capacity to support the rapidly developing ADC and bioconjugation market. As per the press release, the combination of larger-scale GMP manufacturing, advanced analytical capabilities and integrated global services positions the CDMO to support customers from early development through late-stage clinical and commercial manufacturing.
