GenCART Manufacturing Solutions specializes in helping Academic & Small Biotechs navigate product development from research to clinical trial by providing end-to-end manufacture of advanced cellular therapeutic products.
Our proven platforms support adherent and suspension cells, as well as, product lot release testing for both vectors and cells, including sterility, endotoxin, mycoplasma, infectious and particle titers, in vitro adventitious agent testing, RCL/RCA testing, flow cytometry, potency testing, and identity verification by sequencing.
Viral Vector Manufacturing
- LV, RV, & others at research grade, pre-clinical, and through cGMP clinical grade manufacture. Proven platforms for both adherent and suspension cells as well as methods for transient transfection or from stable producer cells.
Plasmid DNA services
- Cloning, custom plasmid manufacturing, off‑the‑shelf plasmids, and control of plasmid supply to eliminate supply chain constraints.
Cell & Virus Banking
- Research & GMP banking of cell substrates, stable producer lines, or viral vectors
- Includes generation of both Master Cell Banks (MCB) and Working Cell Banks
Quality Control Services
- Product lot release testing for both vectors and cells
- Sterility, Endotoxin, Mycoplasma, Infectious & Particle titer, In Vitro Adventitious Testing, RCL/RCA testing, Flow cytometry, potency, identity by sequencing.
Regulatory Support
- Assistance with preparation and submittal of IND and CMC packages
- Attendance at Regulatory meetings upon request
- Support for responding to regulatory requests
- Strategic consultation on clinical readiness and GMP compliance.
Sterile Fill-Finish
- Fill‑finish of viral vectors and cell therapy products
- Compliant chain‑of‑custody systems
- Applicable cryogenic storage with cold‑chain distribution (liquid nitrogen, dry shippers, etc.)
Process development
- Cell line and Viral Vector development
- Tech transfer services
- Development of single use closed-system manufacturing platforms
Contact Us
info@GenCARTbio.com
Contact us to discuss your needs and learn how we can customize our services to meet them..