Pipeline Solutions
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
- 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
- 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
