Sterling Pharma Solutions Expands Capabilities & Laboratory Capacity

Sterling Pharma Solution recently announced a £1 million expansion project at its Deeside, UK site, which is the company’s dedicated bioconjugation and antibody-drug conjugates (ADCs) facility. The project will increase the current laboratory space from 275 to 419 square meters, and reconfigure the layout to provide the ability to develop and expand areas in the future for additional services.

This investment is part of a strategy to support the growth of the company’s ADC capabilities since it acquired the 6,500 square-meter site in April 2021, to expand and develop the facility’s scientific and analytical teams, and establish cGMP bioconjugation/ADC manufacturing capabilities. The work and expansion will allow the recruitment of up to five additional scientists at the facility.

A new mass spectrometer has been installed at the site’s process development laboratory, and in addition to serving Sterling’s ADC business, will provide support for the company’s range of customer analytical services, working in both ADC and small molecule development. The instrument is located in a controlled environment with temperature controls, airlocks, and HEPA filters, allowing the safe handling and analysis of cytotoxic and highly potent materials.

“Having the capabilities to develop ADC bioconjugation methods and scale up through to GMP manufacture in the same location has been one of Sterling’s major priorities since the acquisition of the Deeside facility, enabling projects to progress through development phases without needing relocation or tech transfer,” said Dr. Stewart Mitchell, Sterling’s Deeside Site Head. “We are currently integrating the site’s quality management systems in line with our global practices and are now commissioning the QC and manufacturing facilities in readiness for GMP certification, which we anticipate will be in place by late 2022.”

Sterling’s Deeside facility was part of its acquisition of ADC Biotechnology, which broadened the company’s small molecule drug development services. Sterling has recently announced investment at two further facilities in its global network: a £1.5 million expansion project its early phase development site in Cary, NC; and a planned £10m investment in process development and commercial-scale manufacturing capacity at its headquarters in Dudley, UK. Additionally, in March 2022, Sterling announced a deal to acquire Novartis’ 110-acre Ringaskiddy API manufacturing campus, which is likely to close by the end of 2022.

Sterling Pharma Solutions is a global contract development and manufacturing organization (CDMO) with more than 50 years of experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specializing in handling challenging chemistries. Sterling manages the most complex API challenges from proof-of-concept to commercial manufacture, as well as antibody-drug conjugate (ADC) research and development bioconjugation services. Sterling has four facilities employing more than 800 people: its HQ in Dudley, Northumberland, UK; a dedicated bioconjugation and ADCs facility in Deeside, North Wales, UK; and two sites in the US, in Cary, NC, and Germantown, WI. Find out more.