|BRIT - Research and Analytical Labs|
BRIC – Engineering & Pilot Plant
|BRIM1 – cGMP Manufacturing Facility|
|BRIO – Offices & Space for Future Expansion|
|BRIM3 – R&D/Fabrication Plant|
|BRIM2 – High-Containment Facility|
|SDD Commercial Manufacturing Facility|
Bend Research's drug development facilities accommodate a breadth of capabilities and technologies, which have helped define us as an industry leader in areas such as solubility enhancement and modified release. Within these facilities, we’re able to forge new trails in technology development and continually offer our clients new solutions.
Since the beginning, Bend Research has been proud to call Bend, Oregon, home. It’s where we have developed a unique and vertically integrated structure, enabling us to address our clients’ most difficult problems in any stage of development -- from early discovery to product launch.
R&D and Analytical Laboratories
At our R&D and analytical laboratories, scientists focus on formulation science, conceiving, developing and characterizing customized solutions that meet our clients needs for advanced pharmaceutical technologies.
- Conduct fundamental research into biological processes that pertain to human health
- Conduct fundamental research directed at creating highly configurable customized solutions
- Develop simulation tools for biological processes and delivery technologies
- Explore development of early drug-candidate compounds
- Develop and validate analytical methods for pharmaceutical candidates
Engineering and Pilot Plant
At our engineering pilot plant, we develop processes and scale up technologies, in addition to designing and constructing new equipment to meet specific needs.
- 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
cGMP Manufacturing Facility
We operate a dedicated cGMP manufacturing facility 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.
Our manufacturing staff have significant experience reducing new technologies to practice through the manufacture of safe, high‐quality clinical supplies. Our full‐service Quality Control (QC) laboratory supports method development and validation for raw‐material testing, cleaning methods, and in‐process and product‐release testing.
We are equipped to manufacture a number of end products, from drug product intermediates (e.g., spray-dried dispersions and multiparticulates) to solid dosage forms (e.g., tablets). The capacities of the facility ranges from kilogram quantities up to metric‐ton capacity for Phase 3 clinical supplies under cGMP conditions. At the end of the process, we facilitate technology transfer to larger cGMP manufacturing facilities throughout the world.
- Building Automation System (BAS)
- Single-pass HVAC, 20x per hour
- Temperature/humidity controlled
- Pressure cascade negative to clean corridor
- Safety monitoring for solvent and nitrogen based operations
Our cGMP facility has a proven track record:
- Annual batch success rate of more than 98 percent
- On-time delivery of supplies, meeting clinical and toxicology timelines, even for accelerated delivery schedules
- Extensive history of successful client audits with no critical findings
High-Containment/Biologics Processing Suite
Bend Research has recently added a flexible high-containment facility that is relevant for a wide range of compound types and safety classifications ranging from biologics to small molecule, and inhalation to oral. This stand-alone facility is separated from the company’s other development and cGMP manufacturing facilities and uses the latest best-practice design features and finishes. The facility is designed for safety through state-of-the-art clean room design coupled with engineering controls at the equipment level.
- Maintained to ISO Class 8 Clean Room Classification standards
- HEPA-filtered supply air, up to 50 air changes/hour
- Low-wall-exhaust HEPA units with isolation dampers and monitored dew points
- Safe-change HEPA filters at the face of exhaust grills
- Separate suite ingress/multiple egress capabilities for gowning, decontamination, and degowning
- Flexible air-pressurization rebalancing options for biologics and high-containment operating modes
- Highly cleanable and robust PVC walls, biological cleanroom doors, and fixtures
SDD Commercial Manufacturing Facility
In August, 2015 Capsugel unveiled a new spray-dried dispersion (SDD) commercial manufacturing facility at our Bend Research campus, 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 of early-stage development to late-stage clinical and commercial manufacture. This facility has also been designed to accommodate future capacity additions.
The commercial-scale spray dryer units at this facility are uniquely and efficiently designed to:
- improve product throughput
- minimize cycle times
- accommodate high-potency compounds