Sterling Pharma Solutions, a global CDMO, has expanded its bioanalytical services offering at its Deeside, UK site — which is the company’s dedicated facility for antibody-drug conjugates (ADCs).
The extension sees the building of a new laboratory, which will be used by the analytical services team to support customers’ ADC method development projects.
It will also offer separate bioanalytical services for companies developing biologic drug products and substances.
ADC analytics made easier
The new 210 sqm laboratory has been equipped with a range of instruments for the development of release assays for antibodies and other biomolecules, including chromatographic, electrophoretic, ultraviolet and ELISA-based techniques.
The Deeside facility was granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in June 2023, which allows the manufacture of ADCs for clinical use under current Good Manufacturing Practices (cGMP).
Since the MHRA authorisation, Sterling has manufactured GMP-quality ADC drug substance at the site, which has been delivered for use in clinical trials.
“The global demand for ADC development services has grown over recent years, and having been granted authorisation for clinical-scale GMP manufacturing at Deeside, we need to segregate our analytical teams at the site into method development and quality control to undertake the specific complex testing required for these molecules,” said EVP and Site Head at Deeside, Stewart Mitchell.
“The creation of a new, dedicated method development group with increased resources means that we can expand our services to support additional customers that are developing ADCs and other biomolecules with our scientific and analytical expertise.”
