Synthego offers GMP-grade single guide RNA to support the development of your CRISPR cell and gene therapy. Our GMP-compliant facility encompasses a quality manufacturing system meeting all required standards:
- ISO 9001: 2015 certification
- Compliance with ICH Q7, Section 19, ICH Q9, ICH Q10
- ISO 7 and 8 clean rooms
- Packout in ISO 5 Class II BSC
- Single-pass, HEPA filtered air system
- Temperature, relative humidity, and differential pressure monitoring
- Segregated manufacturing space
With more than 70 successful GMP campaigns, extensive CMC options for release testing and stability studies, and an expert quality team to aid you in your IND filings for your gene-modified cell therapies, Synthego ensures your transition to the clinic is seamless.
