Bend, Oregon, USA

Capsugel’s facilities in Bend, Oregon, are home to its Center of Excellence for Spray-Dried Dispersion (SDD) Technology for bioavailability enhancement. This enabling technology platform offers a solution to address the increasing number of drug candidates with low aqueous solubility. With its integrated product development approach, the Capsugel-Bend team has an array of other technology offerings, such as multiparticulates and particle engineering for inhalation formulations, that span the product-development continuum, from preclinical and first-in-human to late-stage development and commercial production.

Technology Expertise

Many drug candidates have low aqueous solubility and, as a result, low bioavailability, often thwarting the progression of otherwise promising active compounds. At Capsugel, we know that innovative, flexible approaches are needed to solve solubility problems, along with an array of technologies to address specific compound characteristics and meet target product profiles. The SDD technology, which was pioneered in Bend, offers a proven, broadly applicable approach to improve bioavailability and enables rapid, reliable advancement of low-solubility compounds. In addition, Capsugel offers a number of other specialized technologies to meet our clients’ needs. We have the formulation, process development, and manufacturing expertise onsite to create custom solutions tailored to our clients’ needs at a variety of scales.

Bioavailability Enhancement

Center of Excellence for Spray-Dried Dispersion (SDD) Technology

Capsugel’s Center of Excellence for Spray-Dried Dispersion (SDD) Technology at Bend is focused on a breakthrough technology that has been used to advance thousands of compounds with low aqueous solubility. The SDD platform encompasses compositions, processes, and dosage forms designed and proven to meet performance, stability, and manufacturability requirements for a diverse range of compounds. Since it was pioneered in Bend nearly 20 years ago, the SDD platform has proven to be a reliable, highly flexible approach for improving bioavailability, typically from 3- to 15-fold.

Model-Based Process Development and Engineering

Capsugel’s engineering approach is based on fundamental, model-based process development and engineering at all stages of the drug-development process. This focus enables us to address the interaction of formulation physicochemical constraints and process definition to minimize development timelines and risks early in the development process. In late-stage development, these process development models are used to ensure optimization of efficient, robust processes.

Core Services:

  • Process development
  • Emphasis on the interaction between formulation physical science and engineering fundamentals in an approach that saves time, reduces the use of active compound, and minimizes risk
  • Testing capabilities at a range of equipment scales, from milligram-scale feasibility testing to pre-commercial testing on large-scale equipment
  • Spray-drying
  • Extrusion
  • Single and bi-layer tablet compression
  • Functional tablet coating
  • Fluid-bed coating and granulation
  • Melt-spray-congeal processing
  • In-depth modeling, including the following deterministic and statistical approaches
  • Computational fluid dynamics (CFD) modeling
  • Custom predictive biomodeling

Manufacturing

Capsugel’s state-of-the-art manufacturing facilities and process expertise in Bend ensure our clients have access to the right technology to meet their needs. Onsite equipment includes spray-drying, extrusion, immediate-and controlled-release tableting, and multiparticulates. 

Manufacturing support is phase-specific, so we can prepare formulations at bench scale for early feasibility work in our development laboratories, pilot-scale quantities of supplies in our engineering facility, and clinical and commercial supplies in our current Good Manufacturing Practice (cGMP) manufacturing facility.

Core Services: 

  • Conduct fundamental research directed at creating highly configurable customized solutions
  • Explore development of early drug-candidate compounds
  • Develop and validate analytical methods for pharmaceutical candidates
Engineering and Pilot Plant

At Capsugel’s engineering pilot plant in Bend, we develop processes and scale up technologies, in addition to designing and constructing new equipment to meet specific needs.

Core Services: 

  • Develop reproducible, robust processes for manufacturing pharmaceutical formulations
  • Develop tools, including mathematical models, that promote fundamental understanding of the impact of process parameters and equipment configurations
  • Scale up and manufacture formulations at pilot scale
  • Manufacture formulations under non-cGMP conditions for developmental use
cGMP Manufacturing Facility

Capsugel operates a dedicated cGMP manufacturing facility in Bend that specializes in solid oral dosage-form manufacturing, especially for complex dosage forms. The facility, which is designed for maximum flexibility, can accommodate compounds with a wide range of safety classifications, as well as processes that employ organic solvents. We are equipped to manufacture a number of end products, from drug product intermediates (e.g., SDDs and multiparticulates) to solid dosage forms (e.g., tablets). The facility can manufacture amounts ranging from kilogram quantities up to metric‐ton capacity for Phase 3 clinical supplies under cGMP conditions.

SDD Commercial Manufacturing Facility

In August 2015, Capsugel unveiled a new SDD commercial manufacturing facility in Bend, significantly increasing the company’s overall capacity and manufacturing capabilities. Now with three commercial-scale spray dryer units in Bend, Capsugel has established itself as the largest integrated pharmaceutical SDD technology provider in North America with the ability to support customers along a full spectrum from early-stage development to late-stage clinical and commercial manufacture. This facility has also been designed to accommodate future capacity additions.

The unique commercial-scale spray dryer units at this facility are designed to efficiently

  • improve product throughput,
  • minimize cycle times, and 
  • accommodate high-potency compounds.

Community Involvement

Capsugel gives back to the community through a variety of outreach programs. In Bend, we focus on science education due to our unique position in our rural region, but we also support many other organizations that strive to keep Central Oregon a healthier, happier, and safer place to live and work.

Focus on Science Education

We are committed to encouraging interest in science among Central Oregon students. Since 1992, the annual Inventerprise science contest has posed a question to spark the imaginations of would-be scientists, challenging them to pursue inventive solutions to pressing problems. The contest, which is sponsored with help from the Bend-La Pine School District and Central Oregon Community College, attracts more than 1,000 entries each year from K-12 students.

We also offer Science Night, inviting Central Oregon students and their parents and teachers to join us at our Bend facilities for evenings of science and fun. A series of programs, featuring educational science demonstrations, are held several times each year. In a typical year, 600 third- through sixth-graders and 250 adults participate in Science Night, as do winners of the annual Inventerprise science contest. Employees also take the programs on the road, presenting them at small rural schools throughout the region.

Capsugel is a primary supporter of the Bend Science Station, a local nonprofit that promotes science literacy. Funding and board support make it possible for every fifth-grade student in the Bend-La Pine, Redmond, and Sisters school districts to spend time in an educational science laboratory, designing and conducting their own experiments and participating in a range of laboratory and field opportunities.

Leadership in Higher Education and Economic Development

Capsugel supports higher education throughout Central Oregon and particularly values its partnerships with Central Oregon Community College and with Oregon State University-Cascades Campus, both located in Bend. We fund scholarships, provide internship opportunities, sponsor the annual COCC Math Contest, and donate equipment for student use. We also prize our relationships with Oregon Institute of Technology, the University of Oregon, Oregon State University in Corvallis, Portland State University, and Oregon Health and Science University.