Capsugel began investing in the facility in Bend, Oregon following its acquisition of Bend Research in October 2013, injecting $25m (€23m) to expand the site’s pharmaceutical spray-dried dispersion (SDD) commercial manufacturing capabilities.
Having completed the expansion, Bend now has three commercial-scale spray dryers – one for commercial scale development and two for cGMP commercial production – and boasts “the largest integrated capability in North America,” according to President of Capsugel’s Dosage Form Solutions Unit, Amit Patel.
“One of the two new units is already operational with customer projects underway,” he told in-Pharmatechnologist.com. “The newest unit, which is designed to accommodate high-potency compounds, will become fully operational later this year after validation is complete.”
Patel added the new units are designed “to offer a significantly improved product throughput that minimizes cycle times and maximizes productivity.”
He also said while there are a number of companies offering drugmakers SDD services Capsugel is one of the “innovators” in this field and has formulated more than 1,000 compounds using SDD technology. Pharmatek, for example, has recently installed a new SDD unit at its site in San Diego, California.
Now the expansion has been completed, we asked Dan Dobry, Vice President at Bend Research, what areas the firm is now looking at for future growth.
“An estimated 60 percent of compounds in early development have poor solubility,” he explained, and thus customers are demanding technology solutions to help development.
While SDD technology is one option chosen due to its broad applicability across a range of API physicochemical properties and - in many cases – its higher drug loading per unit dose than other approaches, Dobry said the firm is continuing to look at other options to support future products.
“This includes not only more challenging molecules needed for evolving therapeutic targets, but also improved product profiles for specific therapeutic profiles and patient needs,” he said.
“We continue to invest in internal R&D to identify the science and engineering solutions required to support these needs as well as translating those solutions to commercial capability.”