GeneFab
Contract research, development, and manufacturing organization (CRDMO) focused on the design, development, and GMP manufacture of cell and gene therapies. Services cover synthetic biology and gene circuit design, viral vector and mRNA-LNP development, cell therapy manufacturing and cell banking, process and analytical development, rapid technology transfer, and GMP operations.
Industries
Nr. of Employees
small (1-50)
Products
Cell Banking
Engineering, Master, and Working cell bank generation for adherent and suspension platforms, complete with full characterization and qualified storage.
GMP Cell Banking Services
Engineering, Master, and Working cell bank generation with full characterization, qualified storage, and regulatory documentation across adherent and suspension platforms.
Viral Vector Manufacturing Services
Lentivirus and gamma-retrovirus production from adherent (2-20 L) to suspension GMP (50-200 L) supporting both ex-vivo and in-vivo dosing.
CAR-T
End-to-end CDMO services covering autologous and allogeneic CAR-T, TCR-T, and gamma-delta T cell manufacturing, including genetic circuit design, vector supply, cell process, and GMP release testing.
CAR-T & TCR-T Manufacturing Services
Autologous and allogeneic CAR-T and TCR-T workflows including lentivirus or gamma-retrovirus transduction, expansion in G-Rex or WAVE, and fill in bags or vials.
Lentiviral vector
3rd generation lentiviral vector design incorporating EU compliant sterile-grade filtration for gene delivery applications.
Cell Banking
Engineering, Master, and Working cell bank generation for adherent and suspension platforms, complete with full characterization and qualified storage.
GMP Cell Banking Services
Engineering, Master, and Working cell bank generation with full characterization, qualified storage, and regulatory documentation across adherent and suspension platforms.
Viral Vector Manufacturing Services
Lentivirus and gamma-retrovirus production from adherent (2-20 L) to suspension GMP (50-200 L) supporting both ex-vivo and in-vivo dosing.
CAR-T
End-to-end CDMO services covering autologous and allogeneic CAR-T, TCR-T, and gamma-delta T cell manufacturing, including genetic circuit design, vector supply, cell process, and GMP release testing.
CAR-T & TCR-T Manufacturing Services
Autologous and allogeneic CAR-T and TCR-T workflows including lentivirus or gamma-retrovirus transduction, expansion in G-Rex or WAVE, and fill in bags or vials.
Lentiviral vector
3rd generation lentiviral vector design incorporating EU compliant sterile-grade filtration for gene delivery applications.
Services
Definition and optimization of manufacturing processes for cell and gene therapy products, including media/buffer screening and manufacturability assessment.
Development and qualification of analytical methods and QC release panels to support process validation and lot release.
Risk‑based technology transfer including documentation, training, engineering runs, and process/analytical knowledge transfer to GMP facilities.
Clinical manufacturing of cell and gene therapies in commissioned GMP suites with support for batch records, personnel qualification, and GMP operations.
Lot release testing, environmental monitoring, sample management, and stability testing for clinical materials.
Research and GMP cell bank generation (master and working banks), cell bank QC and qualification, and ancillary services such as X‑ray irradiation.
Definition and optimization of manufacturing processes for cell and gene therapy products, including media/buffer screening and manufacturability assessment.
Development and qualification of analytical methods and QC release panels to support process validation and lot release.
Risk‑based technology transfer including documentation, training, engineering runs, and process/analytical knowledge transfer to GMP facilities.
Clinical manufacturing of cell and gene therapies in commissioned GMP suites with support for batch records, personnel qualification, and GMP operations.
Lot release testing, environmental monitoring, sample management, and stability testing for clinical materials.
Research and GMP cell bank generation (master and working banks), cell bank QC and qualification, and ancillary services such as X‑ray irradiation.
Expertise Areas
- Cell and gene therapy development
- Synthetic biology and gene circuit engineering
- mRNA and LNP design and manufacture
- Viral vector development (lentiviral, retroviral, AAV)
Key Technologies
- In vitro transcription (IVT) optimization
- Engineered polymerases for IVT
- Lipid nanoparticle (LNP) formulation
- Codon and sequence optimization
News & Updates
Presence at the American Society for Gene and Cell Therapy annual meeting (listed among events).
Listed participation in multiple scientific meetings relating to cell and gene therapy and immunotherapy.
Announcement of Vadim Eristavi as Vice President/Head of Quality to expand QA/QC capabilities and commercial readiness.
Announcement of a strategic partnership to advance a regulatory T cell therapy into U.S. clinical trials.
Announcement of a new cGMP manufacturing facility in Alameda with capacity to support clinical manufacturing of cell and gene therapies.
Two poster presentations at the American Society of Gene & Cell Therapy (ASGCT) 2024 annual meeting.
Presence at the American Society for Gene and Cell Therapy annual meeting (listed among events).
Listed participation in multiple scientific meetings relating to cell and gene therapy and immunotherapy.
Announcement of Vadim Eristavi as Vice President/Head of Quality to expand QA/QC capabilities and commercial readiness.
Announcement of a strategic partnership to advance a regulatory T cell therapy into U.S. clinical trials.
Announcement of a new cGMP manufacturing facility in Alameda with capacity to support clinical manufacturing of cell and gene therapies.
Two poster presentations at the American Society of Gene & Cell Therapy (ASGCT) 2024 annual meeting.