Will be completed and validated by June 2015
US-based Bend Research, which recently became part of Capsugel’s Dosage Form Solutions (DFS) business unit, is investing US$20m in the expansion of its commercial manufacturing capability for spray-dried dispersions at its plant in Bend, Oregon.
The firm will build a facility with two new high-capacity PSD spray dryer process trains, which will add the capability for handling high-potency compounds.
The investment will provide a complete late-stage development, commercial-launch and commercial-production capability.
The expansion, co-located with the firm's existing GMP development and manufacturing facility, will be completed and validated by June 2015.
'This major investment, after our acquisition of Bend Research, confirms our commitment to continue to expand the capabilities across our entire DFS organisation,' said Guido Driesen, President and 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.'
The new PSD spray dryers will 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,' said 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.'
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. It will be completed and operational by spring 2014.