Sterling Pharma Solutions has announced that it has completed adding a large-scale GMP manufacturing suite at its dedicated bioconjugation facility in Deeside, UK, doubling the site's capacity and increasing manufacturing scale to 500L.
The CDMO announced the £10m investment back in October 2024, with the project including the construction of a new analytical development laboratory and additional office space at the facility.
The new GMP manufacturing suite includes a 500-litre reactor — more than doubling the site's initial capacity — and a 1400 sq ft Grade C cleanroom, allowing the site to now support large-scale GMP projects for pharma and biotech clients.
The new suite can also handle molecules with exposure limits down to 0.05 ng/m3 (OEB 5), with processing undertaken in single-use bioreactors.
In addition to the new GMP suite, Sterling said it also added a new 3400 sqft analytical services laboratory, increasing the site's HPLC and UPLC capacity.
New capabilities include a 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, the new laboratory includes a dedicated area for cell assay method development and analysis.
Investment in this lab includes a 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.
The company added that its Deeside team works closely with its Wisconsin, US facility to develop and manufacture linker payloads, as well as antibody production and sterile fill/finish (drug product).
The Deeside facility was originally established under ADC Biotechnology, before moving to a larger, bespoke 6500m2 site. In 2018, Sterling acquired ADC Biotechnology and integrated the Deeside site into its global network for ADC and bioconjugation services.
