Sterling Doubles UK Bioconjugation Capacity with New GMP Suite

Sterling Pharma Solutions has completed an additional, large-scale GMP manufacturing suite at its dedicated bioconjugation facility in the UK, which will double capacity and increase the scale of manufacturing to 500L.

This multi-million-pound investment also includes a new analytical development laboratory and additional office space at Sterling’s Deeside facility. The site houses specialist bioconjugation teams supporting discovery, development, scale-up, and clinical manufacturing of ADCs and other bioconjugates, including AOCs, APCs, and radio-chelators.

Large-Scale GMP Manufacturing

The new GMP manufacturing suite features a 500-liter reactor and a 1,400 ft2 Grade C cleanroom, enabling the site to support large-scale GMP projects for pharmaceutical and biotechnology clients. Flexible and hard-containment technologies allow the safe handling of highly potent compounds. Using single-use bioreactors, the Deeside facility can process molecules with exposure limits as low as 0.05 ng/m3 (OEB 5).

Expanded Analytical Services

Sterling has also added a 3,400 ft2 analytical services laboratory, expanding both capacity and capability at the site. The laboratory increases HPLC and UPLC capacity and provides a dedicated area for cell-assay method development and analysis.

New analytical capabilities and equipment include:

• UPLC-LC/MS
• Bio-Techne MFI system for particle-size imaging
• Protein-stability characterization instrument
• Automated, plate-based ultrafiltration and diafiltration instrument
• SpectraMax iD3 multimode plate reader
• Agilent NovoCyte flow cytometer
• Thermo EVOS M5000 fluorescence microscope

Andrew Henderson, President EMEA and Chief Commercial Officer, said, “The completion of this additional capacity at Deeside is a milestone in the development of this facility and our bioconjugation service offering. Reacting both to customer need and market demand, we can now offer greater capacity and larger batch sizes, which expands our capability to support development to phase three and, ultimately, commercial. It also makes additional capacity available to our customers immediately.”