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Capsugel and Bend Research Announce New Commercial-Scale Spray-Dried Dispersion Capacity

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Capsugel
535 North Emerald Road
Greenwood, SC, 29646
USA



Press release date: June 3, 2014

Installation marks the first stage of the company's more than $20 million expansion to enhance commercial manufacturing capabilities for spray-dried dispersions

Bend, Ore.– Bend Research, a division of Capsugel Dosage Form Solutions (DFS), announced today that it has installed its first commercial-scale spray dryer in its R&D facility in Bend, Ore. The new dryer allows for seamless process development and scale-up in a non-GMP environment and complements the existing small- and mid-sized spray dryers already in service at the company. The installation completes the first part of the company's multi-stage, more than $20 million expansion to enhance commercial manufacturing capabilities for spray-dried dispersions at its facilities in Bend. Spray-dried dispersion technology helps increase the bioavailability of compounds with low solubility.

“We are excited to introduce this increased spray-dried dispersion capability to our customers. By integrating our product development and commercial manufacturing sites, we can accelerate and de-risk product development, while reducing costs and complexity for our clients,” said Amit Patel, President, Capsugel Dosage Form Solutions. “The continued investment further strengthens our premier capabilities in bioavailability enhancement technologies and innovative product development and manufacturing.”

The new, high-capacity pharmaceutical spray dryer (PSD) can be used for scale-up, quality-by-design studies (QbD), and the production of appropriate toxicology study supplies. In a non-GMP environment, this can provide for faster and more agile development activities, as well as reduced cost and more flexible use of active pharmaceutical ingredients (API). It also allows scale-up aspects of QbD to be integrated earlier into development for spray-dried products.

The installation coincides with ongoing construction to expand the cGMP commercial facility, which includes an additional commercial-scale spray dryer for production of late-stage clinical, launch and commercial spray-dried products. The commercial facility expansion will be completed by mid-2015.

"The installation further strengthens our comprehensive strategy to provide early- through late-stage product development and commercial spray-dried dispersion manufacturing in one location, ” said Jim Nightingale, Managing Director of Bend Research. “When combined with Bend Research’s science-based formulation development, applied mathematics and modeling, and advanced process development tool-kit, we are creating a unique and holistic offering for the development, scale-up, and manufacture of spray-dried products."

Several pharmaceutical companies are already working with Bend Research to prepare for the launch and ongoing commercial supply of their new spray-dried dispersion compounds from Capsugel’s site in Bend, Ore. With the integration of Bend Research, Capsugel Dosage Form Solutions offers product development and manufacturing solutions through nearly all bioavailability-enhancing platforms, including lipids, liquids, hot melt extrusions, salt forms, and nanotechnology, in addition to amorphous dispersions.

About Bend Research
For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve
human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to
develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering
fundamental understanding. Bend Research is a leader in novel formulations, including spray-dried dispersion (SDD) and hotmelt
extrusion (HME) formulations, as well as controlled-release, inhalation, and biotherapeutics technologies. Bend Research is
now a division of Capsugel’s Dosage Form Solutions business unit.

About Capsugel
Capsugel is a global leader in delivering high-quality, innovative dosage forms and solutions to its customers in the health care
industry. The company’s Hard Capsule business offers customers the broadest portfolio of gelatin, vegetarian, and other
specialized capsule technologies. Capsugel’s Dosage Form Solutions (DFS) business utilizes an array of proprietary technologies and specialized manufacturing capabilities to solve customers’ most pressing product development challenges, including bioavailability enhancement, modified release, abuse deterrence, biotherapeutic processing, and inhalation formulation. The company's fast-to-clinic program streamlines product development from pre-formulation through clinical and commercial supply for finished dosage forms. Headquartered in Morristown, N.J., Capsugel serves more than 4,000 customers in more than 100 countries. For additional information, visit www.capsugel.com.
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