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

  • Plasmid design

  • Producer cell line development

  • Upstream processing

  • Downstream processing

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

Adherent: ≤ 70L

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

Follow Us On Social

Genezen Laboratories

@GenezenLabs

  • This field is for validation purposes and should be left unchanged.

© 2021 GENEZEN LABORATORIES