cGMP - Current Good Manufacturing Practice Capabilities
Bend Research's cGMP (current Good Manufacturing Practice) capabilities are a critical link in advancing promising compounds to commercialization.
Our cGMP facilties have been:
- Designed for maximum flexibility for clients who require solid oral dosage-form manufacturing, especially for complex dosage forms
- Equipped to manufacture a number of end products, from drug product intermediates (e.g., spray-dried dispersions, hot-melt extrusion, and multiparticulates) to solid dosage forms (e.g., tablets and capsules)
- Designed to support compounds with a wide range of safety classifications and accommodates the use of processes that employ organic solvents, and
- Offers capacity ranging from kilogram quantities up to metric tons for Phase 3 clinical supplies under cGMP conditions
In addition, 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. The proximity of the manufacturing facility to our engineering pilot-plant facility enables facile process development, technology transfer, and optimization and it enables rapid response of the complete team (technical, quality, client representation) required for timely decision making for clinical manufacturing.
In addition to its primary cGMP manufacturing facility, Bend Research has a satellite facility dedicated to the development and manufacture of biologic, high-containment, and inhaled products.
This stand-alone facility offers
- Dryer scale
- Capsule fill
- Flexible design
- Containment environmental handling
Bend Research offers extensive state-of-the-art equipment for cGMP manufacturing. Review our list of formulation development/process analytical equipment.
Advanced Science and Engineering
- We deliver high-quality clinical pharmaceutical products using innovative science and engineering best practices.
Proven Track Record
- Our manufacturing facility has an excellent record for quality, scoring very high on audits and having an exceptional reputation for lot success.
Contact us to discuss your clinical trial