cGMP Cell Banking Services
Trust Covance for complete cGMP master (MCB) and working (WCB) cell bank generation and cell line biosafety testing. As one of the first CROs to obtain a MHRA (Medicines and Healthcare Products Regulatory Agency) manufacturing license for cGMP cell bank production, put our 20 years of experience to work for you when you need independently prepared cell banks from a contract manufacturer, or biosafety services accepted by FDA and European regulatory authorities.
Cell bank production
Expand your in-house availability with Covance. Our spotless track record and approach is designed for smooth process transfer from seed stock to cell bank.
- Cell banks prepared in classified and validated clean room suites
- Comprehensive cleaning/environmental monitoring programs
- Preliminary MCBs production suitable for cGMP pilot studies
- Production of early phase material
- MCBs and WCBs for late phase study or in-market supply production
- Zero contamination record due to human errors
Cell bank storage
Ensure safe, secure, reliable storage of your cell banks throughout its development and commercial production. Covance has:
- Fully GMP compliant liquid nitrogen storage system for primary or secondary site cell bank storage facilities
- Tolerance limits, calibration, disaster recovery arrangements
- Viability, stability and adventitious agent testing
Download a brochure on Cell Banking and Biosafety Testing Services.
Fully validated cGMP facility complemented by a comprehensive validation master plan (VMP) for services, processes and equipment.
Take a virtual tour of our newly expanded, optimally designed cell banking and biosafety testing facility.
Click here to learn more about Covance biomanufacturing support services.