PROCESS DEVELOPMENT
Genezen’s process development team will partner with you to develop or optimize a robust process that is repeatable and transferable to cGMP scale manufacturing. We will work with you and your specific priorities for continuous process improvement as your therapy progresses from bench to clinical trials.
Early Development | Non-cGMP Production | Phase I-II cGMP Productions | |
Process Optimization |
| Test runs at variable scale for further optimization in the process development lab | Optimized cGMP runs |
Easy Scale Up | Selection of viral vector platform and cell line for vector production | Cost effective process runs before cGMP productions | Suspension: ≤ 200L |
Well Controlled Process | Reproducible process design with commercialization approach | Further optimization to get to a closed and continuous system for vector production | Closed system production from upstream through downstream processing |
SERVICES
Genezen offers contract process development, GMP viral vector production, transduced cell manufacturing, and testing services by leveraging inhouse capacity combined with the expertise of the nation’s leading academic vector production and research laboratories.
QUESTIONS?
For more information on our services, contact us at info@genezenlabs.com or submit this form.
Address:
Genezen Laboratories
9900 Westpoint Dr, Suite 128
Indianapolis, IN 46256
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