The Analytical Sciences group at Bend Research supports drug development by providing analyses across the entire development process -- from feasibility testing to current Good Manufacturing Practice (cGMP) manufacturing of clinical trial supplies. Analytical Sciences offers critical laboratory support in such diverse areas as manufacturing scale-up, testing of raw materials and final products, and cleaning verification of processing equipment.
The Analytical Sciences group works with all of the research groups at Bend Research, stepping in with their special expertise to assist with emerging challenges or opportunities. Response times are rapid, keeping projects moving to meet clients’ time frames and quality expectations.
Two Labs, Full Service
Analytical Sciences maintains two GMP laboratories: a Quality Control lab at our cGMP manufacturing facility and a second full-service lab at our science and analytical laboratories. The cGMP laboratories provide the following services:
- Multicompendial testing of raw materials
- Testing of noncompendial raw materials
- Product-specification support
- Phase-appropriate method development and validation
- In-process product testing
- Finished-product release testing
- ICH stability testing
- Equipment cleaning verification and validation support
- Testing for high-potency compounds
- Investigative and troubleshooting support
Quality Control Through Critical Testing
- Raw Materials Testing ensures that each formulation component meets established Quality requirements.
- In-Process Assays establish that manufacturing processes are proceeding according to plan
- Final Product Assays verify that product specification requirements have been met
- Stability Testing evaluates the useful shelf life of the product
Contact us for more information on how our analytical laboratories can support the advancement of your projects at Bend Research.