Assay Development & Validation
Our Analytical Team has decades of experience in assay development and full validation of test methods and processes. We specialize in working with small organizations and start-ups, getting their groundbreaking ideas and technologies to commercialization, offering more attention and detail to a project than the large contract manufacturers are able to provide.
Below, you'll find a brief listing of services offered.
| Analytical | Method Setup Method Validation Batch QC Product Characterization | Process | Method Development Process Setup GLP/Engineering Batch Production cGMP Production |
| Viral Clearance | CRO Studies • Full Project Support and Management | Stability Studies | CRO Studies • Full Project Support and Management • Real-Time, Accelerated and Stress-Testing |
| Regulatory Documentation | CMC Documentation |
Lee Biosolutions, Inc
