Sterling acquired its facility in Cary, North Carolina, to create a physical presence close to the pharmaceutical and biotech hub Research Triangle Park. The decision to acquire the site was a result of increased customer demand in North America market with more than 70% of Sterling’s customer portfolio now based in the region.
We deliver expert chemistry solutions for pre-clinical and early phase clinical supply from the facility and can cater for volumes from millilitres up to 50 litre batches, ideal for small volume products or products in the early stages of clinical trials.
The facility features cGMP API manufacturing capabilities and is able to produce high value, low volume APIs including high barrier to entry compounds that are generally difficult to manufacture.
There is also a well-equipped GLP analytical lab on site which medicinal chemistry and custom synthesis capabilities, which is used to support our GMP laboratory. The quality control staff on site are highly trained and oversee all release testing and certification to ensure our products meet the highest standards before being released to the US market for export.
Our facilities at this site include:
- Two GMP synthesis laboratories
- Three R&D laboratories
- cGMP analytical laboratory
Services offered from our US facility include:
- cGMP API manufacturing
- Support documentation for IND/ANDA/NDA filings
- Process development including optimisation of existing processes and identification of new, non-infringing processes
- Handling of controlled substances (Schedule II-IV)
- Drug discovery services including new route development, lead optimisation
Get in touch with the team today.