High demand encourages Sterling Pharma's phased expansion of its US facility

The investment will allow the CDMO to take on new projects, as well as bolster the company's chemistry development capabilities.

The investment follows the acquisition of the former US CiVentiChem site earlier this year. Over the next 3 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.

Mat Minardi, President 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.

“The specialist capabilities provided by Sterling, particularly our ability to handle challenging chemistries, 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. We’re confident this investment will be of huge benefit to our customers.”

The investment plan will also allow Sterling to expand its quality assurance (QA) 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-L batches. The team has expertise 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.