Bend Research Inc., which recently became part of Capsugel’s Dosage Form Solutions business unit, announced Thursday an investment of more than $20 million to expand commercial manufacturing for spray-dried dispersions at its facilities in Bend.
The investment will encompass a facility expansion dedicated to commercial manufacturing with two new high-capacity PSD spray dryer process trains. The new process trains are flexible and bring the capability for appropriate handling of high-risk/high-potency compounds.
"The investment is part of a comprehensive strategy to provide customers with complete late-stage development, commercial-launch and commercial-production capability at Bend Research," the announcement said.
The rest of the release, in full:
The commercial facility expansion, co-located with the existing GMP development and manufacturing facility, will be completed and validated by mid-2015, company officials said.
“This major investment, after our acquisition of Bend Research, confirms our commitment to continue to expand the capabilities across our entire DFS organization,” said Guido Driesen, president & CEO of Capsugel. “Our goal is to provide clients with innovative dosage form solutions by bringing together industry-leading R&D expertise and world-class manufacturing capabilities.”
Several companies have already indicated that Bend Research has been chosen as the launch site for their new spray-dried dispersion compounds. The investment adds to existing development and GMP of small and mid-sized spray dryers already in service at the company.
The new PSD spray dryers are designed for enhanced flexibility and capability. They can be used to generate optimally engineered particles to meet the needs of a given formulation and therapeutic application. In addition, the throughput and efficiency of the spray dryers is enhanced through specific dryer design and equipment innovations.
“Our new commercial wing will allow the production of registration lots, commercial launch, and continued supply of new products from the Bend Research facilities,” stated Bend Research CEO Rod Ray.
“Commercial production at Bend Research will be supported by a designed-for-purpose, risk-based quality system aligned with the principles of ICH Q10 Pharmaceutical Quality System regulations. Our quality system will incorporate best practices in late-stage development and commercial GMP production of pharmaceutical compounds.”
In addition to the new commercial production lines, the company is building a high-capacity PSD spray dryer in its process-development pilot facility.
The development process train will be used for scale-up, quality-by-design studies (QbD), and the production of appropriate toxicology study supplies.
This new PSD dryer will allow seamless process development and science-based scale-up to an appropriate commercial scale in a non-GMP environment. The development spray dryer addition will be completed and operational in the spring.