The UK-based global CDMO plans to expand the cGMP production suites, add a non-GMP scale-up production facility, expand its QC lab and increase the North Carolina site’s R&D capacity
The former US CiVentiChem in North Carolina
Sterling Pharma Solutions, the UK-based global CDMO, is investing US$1.5 million into a phased expansion of its US facility in North Carolina. Over the next three years, the company plans to expand the cGMP production suites, add a non-GMP scale-up production facility, expand its QC laboratory and increase the site's R&D capacity.
The investment follows the acquisition of the former US CiVentiChem site earlier this year, marking Sterling’s first physical location in the US market.
Mat Minardi, President of US Operations, said: "The North American market now makes up 70% of our customer portfolio. And, having expanded our US presence earlier this year with the acquisition of our facility in North Carolina, we have continued to experience strong growth."
"This investment will allow us to continue to meet customer expectations and take on new projects, as well as bolster Sterling's chemistry development capabilities."
Minardi explained that CDMO services are in high demand as a result of the increasing complexity of products entering the drug pipeline and the need for more efficient and cost-effective production of APIs.
The investment plan will also allow Sterling to expand its quality assurance team to provide more support for cGMP projects, increase its team of chemists and put measures in place to help it secure its US Drug Enforcement Administration (DEA) Schedule I manufacturing approval. This recruitment drive, along with the initial facility expansion, forms the first part of the phased investment.
The facility, located close to Research Triangle Park, supports the development and manufacturing requirements for pre-clinical and early phase clinical supply for volumes from millilitres up to 100 litre batches. The team has experience in medicinal chemistry services, including lead optimisation and parallel synthesis, cGMP analytical services to support testing and release, process development and small-scale API manufacturing.
This latest investment is part of Sterling's ongoing growth strategy and follows the completion of the majority acquisition of Sterling Pharma Solutions by specialist European healthcare investor, GHO Capital this year.
As part of its expansion plans, Sterling is also recruiting for its US BD and sales team.
Sterling Pharma Solutions, which has sites in the UK and the US, is a well-established developer and manufacturer of pharmaceutical APIs. Specialising in hazardous chemistry and handling controlled substances, the company is dedicated to continuously developing innovative solutions to customer challenges, such as handling potent molecules and increasing operational effectiveness.
Sterling Pharma Solutions will be exhibiting at CPhI in Frankfurt (5-7 November 2019) in Hall 10.1, Stand 101A60.