- Sterling Pharma Solutions has completed an additional large-scale GMP manufacturing suite at its dedicated bioconjugation facility in Deeside, UK, doubling capacity and increasing manufacturing scale to 500L.
- The multi-million-pound investment also adds a new analytical development laboratory and office space to support clinical and commercial development of ADCs and other bioconjugates.
Sterling Pharma Solutions has completed an additional large-scale GMP manufacturing suite at its dedicated bioconjugation facility in Deeside, UK. The new suite doubles the facility’s capacity and increases its manufacturing scale to 500L. The investment also includes a new analytical development laboratory and additional office space.
The new GMP suite includes a 500L reactor and a 1,400ft² Grade C cleanroom. It is designed to support large-scale GMP projects for pharmaceutical and biotechnology clients and uses flexible and hard containment technologies for highly potent compounds. The facility can handle molecules with exposure limits down to 0.05ng/m³ (OEB 5), with processing undertaken in single-use bioreactors.
Sterling has also added a 3,400ft² analytical services laboratory, increasing HPLC and UPLC capacity. New capabilities include UPLC-LC/MS, particle size imaging, protein stability characterization, automated ultrafiltration and diafiltration, and a dedicated area for cell assay method development and analysis. The laboratory also includes new analytical equipment for plate reading, flow cytometry and fluorescence microscopy.
“The completion of this additional capacity at Deeside is a milestone in the development of this facility and our bioconjugation service offering. The expanded capacity and larger batch sizes will support development through Phase III and ultimately commercial manufacturing, while making additional capacity immediately available to customers.”
Andrew Henderson, President EMEA and Chief Commercial Officer at Sterling Pharma Solutions
The Deeside facility supports discovery, development, scale-up and manufacturing of clinical ADCs and other bioconjugates, including AOCs, APCs and radio-chelators. Sterling also has ADC capabilities at its Wisconsin, US facility for linker-payload development and manufacturing, working with the Deeside team and partners involved in antibody production and sterile fill-finish to provide an end-to-end service for clinical development and manufacturing.
