CDMO Sterling Pharma Solutions has committed to a £10m investment into its GMP bioconjugation capabilities at its Deeside, UK site.
The novel 2,300 sqft suite is being commissioned to allow clinical-scale manufacturing using reactors up to 500 L in volume.
This expansion will more than double the site's existing capacity, while offering its customer more flexible scale-up solutions as they progress through the development process.
Within the new suite, there will be a 1,400 sqft Grade C cleanroom dedicated to ADC manufacturing, which incorporates both flexible and hard containment technologies to safely handle HPAPIs with exposure limits as low as 0.01μg/m3.
Processing will be conducted within single-use bioreactors, which increase efficiency and eliminate the risk of cross contamination; control systems will also reduce the need for manual operation.
Alongside this expansion, Sterling is upgrading its stability chamber capacity to store and monitor customer's final products; this project is expected to be completed by early 2026.
Sterling Pharma Solutions Chief Operating Officer, Andrew Henderson, commented: “The interest in ADCs as a drug modality is evolving, as innovators look to leverage their potential towards a number of targets beyond oncology, and there is a recognised global shortage of capacity for scale-up, resulting in a bottleneck in development,”
“This expansion will more than double our manufacturing capacity and allow us to handle both larger batch sizes and more complex processes, increasing our flexibility to undertake a wider number of projects. Sterling has an ongoing, long-term strategy for the facility at Deeside and this investment is the second step of that, to ensure we can meet the changing needs and demands of customers as the ADC market continues to grow.”
The Deeside facility was granted a Manufacturer's Authorisation from the MHRA in April 2023, meaning the company is permitted to manufacture ADCs for clinical use under the current cGMPs.