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Clinical Vector Core Services
Below is a listing of our services and quality control.
Services
- Manufacturing of GMP-grade and GMP-comparable AAV and LV vectors
- Long-term stability testing services consistent with the duration of the Phase 1/2 study
- Device compatibility and short-term stability studies
- Manufacturing of GMP-grade and non-GMP grade excipient
- Regulatory support for Investigational New Drug (IND) applications
- Letter of cross reference to our Drug Master File (DMF)
Quality Control
- Bioburden/Sterility
- Bacteriostasis/Fungistasis
- Mycoplasma
- Endotoxin
- Replication Competent AAV
- Replication Competent LV
- Adventitious agents
- Other