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Drug Product Intermediate Manufacturing

Drug product intermediates are produced at the cGMP facilities in Bend, OR, using spray dried dispersion technology, hot melt extrusion, nanotechnology, and fluid bed processing. The Bend Research facilities are designed for clients seeking flexibility in the design, development, and supply of clinical trial and commercial quantities of finished dosage forms. The site is also a center of excellence for modified release applications, specifically osmotic, multi-layer matrices and multiparticulate technology.

Flexibility – We believe in co-located product development and manufacturing to ensure accelerated product development. As such, we are equipped to manufacture a number of end products from drug product intermediates to solid dosage forms in either tablet, multiparticulate and capsule formats using our range of enabling technologies.

Drug Product Intermediates

Finished Dosage Forms

Range - Our facilities are designed to support compounds with a wide range of safety classifications and accommodate the use of processes employing organic solvents, e.g. spray-dried dispersions and fluid bed coating of multiparticulates.

Capacity - We can produce kg quantities for feasibility assessment up to metric tons for phase 3 clinical trials and commercial applications. A new spray-dried dispersion commercial suite is currently under construction and is expected to be completed in mid-2015. This suite will expand our capacity for late-stage clinical, launch and commercial spray-dried products.

Quality Control – As part of our integrated approach to formulation development, the Bend site employs a full service quality control (QC) laboratory which supports method development and validation for raw material testing, and in-process and product release testing.

Our cGMP manufacturing carries a proven track record with an annual batch success rate of over 98%, and an extensive history of successful client audits with no critical findings to date. The facility is equipped and staffed for meeting clinical and toxicology timelines, even for accelerated delivery schedules.

Engineering & Pilot Plant

At our engineering pilot plant, Bend Research scientists and engineers develop processes and scale up technologies in addition to designing and constructing new equipment to meet specific needs.

High Containment / Biologics Processing Suite

Our flexible high containment, stand-alone facility uses the latest best-practice design features and finishes. The facility can accommodate a wide range of compound types and safety classifications ranging from biologics to small molecules for oral or inhalation delivery routes.

Additional Resources

Bend Research equipment list

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