Contract development and manufacturing organisation (CDMO), Sterling Pharma Solutions has announced completion of an additional, large-scale GMP manufacturing suite at its dedicated bioconjugation facility in the UK, which will double capacity, as well as increasing the scale of manufacturing to 500L.
The multi-million-pound investment has also seen the construction of a new analytical development laboratory and additional office space at the facility in Deeside, which houses Sterling’s specialist bioconjugation teams for discovery, development, scale up and manufacturing of clinical ADCs and other bioconjugates, including AOCs, APCs, and radio-chelators.
The new GMP manufacturing suite includes a 500 litre reactor and a 1,400ft2 Grade C cleanroom, allowing the site to support large-scale GMP projects for pharma and biotech clients. The new suite will utilise both flexible and hard containment technologies to enable the handling of highly potent compounds. The Deeside facility can handle molecules with exposure limits down to 0.05ng/m3 (OEB 5) with processing undertaken in single-use bioreactors.
In addition to the new GMP suite, Sterling has invested in a new analytical services laboratory adding additional capacity and capability. The new laboratory, which totals 3,400ft2, increases the HPLC and UPLC capacity at the site. New capability includes an UPLC-LC/MS, a Bio-Techne MFI for particle size imaging, a protein stability characterisation instrument and an automated, plate based ultrafiltration and diafiltration instrument. In addition to this, the new laboratory also includes a dedicated area for cell assay method development and analysis. Investment in this lab includes Spectramax ID3s multimode plate reader, an Agilent NovoCyte flow cytometer and a 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.”
Sterling also has specialist ADC capabilities at its Wisconsin, US facility to develop and manufacture linker payloads, working in close collaboration with the Deeside team, as well as key partnerships across antibody production and sterile fill/finish (drug product). This enables Sterling to provide a full, end-to-end service for the clinical development and manufacturing of ADCs and other bioconjugates.
