Sterling Pharma Solutions Expands Capabilities and Laboratory Capacity

Sterling Pharma Solutions, a global contract development and manufacturing organization (CDMO), announced on April 5, 2022 a £1 million expansion project at the company’s bioconjugation and antibody-drug conjugates (ADCs) facility in Deeside, UK.

The project will expand the laboratory space from 275 to 419 square meters and reconfigure the facility’s layout to better support the development and expansion of areas for future additional services. The investment is part of a broader goal of the growth of the company’s ADC capabilities since the acquisition of the UK site in April 2021. Other goals include expanding the facilities scientific and analytical teams, establishing current good manufacturing practice (CGMP) bioconjugation/ADC manufacturing capabilities, and recruiting up to five additional scientists at the facility.

The site’s process development laboratory has expanded with the addition of a new mass spectrometer, which will serve the company’s ADC business as well as support the company’s customer analytical services of ADC and small-molecule development. The instrument is able to safely handle and analyze cytotoxic and highly potent materials due to its location in a controlled environment with temperature controls, airlocks, and HEPA filters.

“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 Stewart Mitchell, Sterling’s Deeside site head, in a press release. “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.”

Source: Sterling Pharma Solutions