Quality Control and Other Assays
Qeen Biotechnologies excels in rigorous quality control and comprehensive assay services, ensuring the safety, efficacy, and consistency of bacteriophage products. Our expert services include:
Product Characterization
- Physical appearance assessment
- Identity confirmation (qPCR, sequencing)
- Purity analysis
- Titration
- pH measurement
Safety and Purity Testing
- USP Sterility testing
- USP Bioburden analysis
- Host cell DNA content quantification
- Endotoxin level determination
- Total protein content measurement
Method Development and Validation
- Establishment of specifications and reference materials
- Characterization of reference materials
- Method familiarization and development
- Qualification protocols creation
- Execution of qualification/validation
- Preparation of qualification reports
Comprehensive Testing Services
- In-process testing
- Release testing: raw materials, banks, drug substances, drug products
- Stability testing
- Master batch record development
- Vendor qualifications
Manufacturing Support
- Water runs
- Engineering runs: Media fills
- Drug product manufacturing (Clinical Trial Materials)
- Placebo production (Clinical Trial Materials)
- Pharmacy manual development