Blue Stream Laboratories provides solutions for each phase of drug development:

R&D Services

• Identity and Purity Assay Development
• Product Characterization Assays
• Activity Assay Development
• Early Formulation Support
• ELISA/Immunoassay Development and High-Throuput Screening Assays

CMC Services

• Assay Development and Characterization of Protein Products
• Protein/Glycoprotein Structural Characterization
• Stability Program Design & Management; Preclinical Program Support
• ELISA/Immunoassay Development & Qualification
• Pre-Formulation support services
• Raw Material and Drug Substance Method Development and Optimization
• Microbiological & Sterility Support Services
• Method Transfer/Qualification
• CMC Guidance and Consultation
• Technical and regulatory guidance for development and release testing programs

Clinical/Commercial Product Services

• Manufacturing Change Evaluations: Lot Comparability (equivalency)
• cGMP Release Testing; Full Program management
• Stability Program Design & Management supporting Clinical and Commercial Products
• Raw Material and Drug Substance/Product Release Testing: Full Program Management
• Microbiological & Sterility Support Services
• Method Transfer/Qualification/ICH-cGMP Validation
• Technical and Regulatory Guidance for Release Testing Programs
• Cleaning Validation Support Services