GeneFab
GeneFab is a privately held cell and gene therapy CRDMO offering integrated genetic design, cell therapy, and viral vector manufacturing to therapy innovators across discovery through commercial supply, anchored by cGMP facilities in Alameda and South San Francisco.
- Company typePrivate
- Founded2023
- HeadquartersAlameda, United States
- Headcount51–100
- GTM typeB2B
- OfferingServices
What GeneFab does
GeneFab is a privately held cell and gene therapy contract research, development, and manufacturing organization (CRDMO) founded in 2023 and headquartered in Alameda, California, with a second site in South San Francisco described as a Synthetic Biology Center of Excellence. The company operates a 42,000 sq ft purpose-built cGMP facility in Alameda (seven Grade B cleanrooms in two segregated wings, expandable to 92,000 sq ft) and serves gene and cell therapy innovators from discovery through commercial supply. Its service portfolio spans Genetic Design (ML-driven sequence and construct design plus proprietary building blocks), Cell Therapy Platforms (autologous and allogeneic manufacturing of CAR-T, TCR-T, CAR-NK, Treg, iPSC and related modalities), Viral Vector Platforms (lentiviral and gamma-retroviral vectors, adherent and suspension, with stable producer cell lines), Cell Banking, Process Development, Analytical & Assay Development, Quality Control & Release, Stability Studies, and Commercial Readiness & Supply.
GeneFab's technical differentiation rests on an integrated synthetic biology and manufacturing stack. Proprietary building blocks include cell-specific synthetic promoters validated across hepatocytes, immune cells, and engineered stem-cell derivatives; drug-induced molecular switches tunable by FDA-approved small molecules; engineered kill switches for selective elimination of modified cells; and ML-driven sequence and construct design that compresses thousands of variants into a clinically tractable set. Manufacturing leverages PBS Vertical Wheel bioreactors (0.1–80 L) combined with XCell ATF perfusion for CAR-NK process intensification, third-generation self-inactivating lentiviral vectors with proprietary cell-specific promoters, and stable producer cell lines designed to improve unit economics at 50–200 L suspension GMP scale.
Commercially, GeneFab operates a project-based professional services revenue model with quote-based pricing under negotiated Project Proposals governed by a Standard Service Agreement, net 30 in USD, alongside multi-year managed-service partnership programs featuring dedicated Program Management Officers, joint steering committees, and cloud-based document sharing. Free consulting services (sequence design, vector selection, antigen design) are bundled to attract and retain program work. Publicly disclosed engagements include a manufacturing agreement covering Phase 1 supply for Senti Biosciences' SENTI-202 and a 2025 partnership with RegCell, supported by research presentations at ASGCT 2024 and CAR-NK process intensification publications in 2025.
GeneFab firmographics
Firmographics- Name
- GeneFab
- Legal name
- GeneFab LLC
- Website
- https://genefab.com
- Company type
- Private
- Founded year
- 2023
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- GeneFab is a privately held cell and gene therapy CRDMO offering integrated genetic design, cell therapy, and viral vector manufacturing to therapy innovators across discovery through commercial supply, anchored by cGMP facilities in Alameda and South San Francisco.
- Ownership category
- akta.pro rank
GeneFab industry classification
Industry- Product category
- Cell & Gene Therapy CDMO Services
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Gene Therapy (Viral Vector/Plasmid) CDMO (HLAGABAE)
- akta.pro secondary industries
- Gene Therapy Analytical Testing & QC (potency, vg/ddPCR, infectivity, RCL/RCA) (HLAAACAK), Gene Therapy Regulatory, Pharmacovigilance & Clinical Operations Services (HLAAACAM)
Keywords
Where GeneFab is headquartered
LocationHeadquarters
- HQ city
- Alameda
- HQ country
- United States
- HQ region
- North America
Markets served
GeneFab business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales
Revenue model
- Contract research, development and manufacturing services (CRDMO): Custom/contract research, process development, analytical development, cGMP manufacturing and clinical supply services delivered under Project Proposals governed by the Standard Service Agreement. Engagements range from discovery support through IND-enabling, clinical, and commercial supply; project-based with invoices upon completion and acceptance of deliverables, paid in USD within 30 days of invoice. Free consulting services (sequence design, vector selection, antigen design) are bundled at no charge to attract and retain program work.
- Long-term CRDMO partnership programs: Multi-year, integrated development-to-commercial partnerships with dedicated Program Management Officer (PMO), joint steering committee, transparent cloud-based document sharing, and milestone-based billing. Designed to scale from clinical through commercial supply without changing partners, with programs evolving from research-scale exploration to commercial-scale supply.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based CRDMO pricing under negotiated Project Proposals |
Go-to-market motion2 records
GeneFab product offering
Product offeringCore offering
GeneFab is an integrated cell and gene therapy Contract Research, Development, and Manufacturing Organization (CRDMO) offering end-to-end services spanning synthetic biology construct design, process and analytical development, cGMP cell therapy and viral vector manufacturing, cell banking, QC release, stability, and commercial supply. The platform combines ML-driven genetic design and proprietary cell-specific promoters and drug-induced switches (South San Francisco) with a 42,000 sq ft cGMP facility featuring seven Grade B cleanroom suites (Alameda) to support autologous and allogeneic cell therapy, lentiviral and gamma-retroviral vectors, and in-vivo gene therapy programs.
Product overview
GeneFab is a single integrated cell and gene therapy CRDMO platform rather than a modular SaaS product: each named capability listed above is an in-house service that stitches into one continuous workflow from genetic design through commercial supply, with the same team and same roof spanning the program. The Synthetic Biology / Genetic Design engine in South San Francisco generates the constructs (including the proprietary cell-specific promoters, kill switches, drug-induced switches, and stable producer cell lines) that feed Process Development and Analytical & Assay Development in Alameda; these in turn feed Cell Therapy Platforms and Viral Vector Platforms manufacturing, supported by Cell Banking, cGMP Manufacturing, QC & Release, Stability Studies, and Stability Sample Storage. Rapid Technology Transfer and Integrated GMP Project Teams (with a dedicated PMO) wrap around the technical services to move programs from R&D through IND-enabling, clinical, and Commercial Readiness & Supply without vendor or site handoffs.
Differentiator
Problem solved
Functional benefit
Products and services
- Genetic Design Synthetic biology research engine providing ML-driven sequence optimization, bioinformatics analysis, high-throughput construct screening, and proprietary building blocks such as cell-specific promoters, kill switches, drug-induced molecular switches, and stable producer cell line engineering for cell and gene therapy innovators.
- Cell Therapy Platforms End-to-end autologous and allogeneic cell therapy manufacturing covering CAR/TCR-T, CAR-NK, Treg, iPSC, aggregate cultures, and other adherent or suspension cell modalities, with expansion on G-Rex, WAVE, and PBS Vertical Wheel (0.1–80 L) platforms, plus cryopreservation, formulation, and fill/finish.
- Viral Vector Platforms Engineered lentiviral (LVV) and gamma-retroviral (GRV) vector manufacturing across adherent (2–20 L) and suspension (1.5–200 L GMP) formats, including transient transfection or stable producer cell lines, multiple envelope pseudotype options, and integrated cell-specific promoters and molecular switches.
- Cell Banking Engineering, Master, and Working cell bank generation across adherent and suspension platforms, with full release panel (viability, identity, purity, transgene expression, RCV, sterility, mycoplasma, endotoxin, adventitious agents) and in-house irradiated feeder cell generation via qualified X-Rad 320 irradiator.
- Rapid Technology Transfer Structured, risk-based technology transfer methodology covering process, analytical, and quality gap assessments, engineering runs with on-the-floor MSAT, delta analysis, and documented transfer packages, with typical development-to-GMP timelines of ~7 months and commercial-to-commercial up to 24 months.
- Integrated GMP Project Teams Dedicated cross-functional team and Program Management Officer per program, with transparent Gantt charts, cloud-based document and data sharing, joint steering committees, and routine technical/quality reviews spanning SynBio, process development, analytical, manufacturing, and QC.
- Process Development Unit operation design, optimization, scale-up, and lock-in for cell therapy and viral vector programs, with on-the-floor MSAT support during engineering runs and cost-of-goods modeling alongside process design.
- Analytical & Assay Development In-house analytical development covering identity, purity, potency, and safety methods (flow cytometry, dPCR/qPCR, ELISA, Luminex, cytotoxicity, multi-parameter functional assays), with phase-appropriate qualification and validation per USP/EP standards.
- Quality Control & Release In-house microbiology and raw material testing (endotoxin, sterility, mycoplasma, environmental monitoring, FTIR identity), full CGT release panel (viability, identity, purity, potency, vector copy number), suitability studies, method validation per USP/EP, and environmental monitoring performance qualification.
- Stability Studies ICH and product-specific stability program design and execution, including real-time, accelerated, and stress studies; in-use, hold-time, and shipping stability; trending and statistical analysis; and shelf-life determination and extension studies.
- Stability Sample Storage GMP-compliant, qualified and temperature-mapped stability chambers with continuous monitoring, controlled ambient, refrigerated, frozen, and ultra-low conditions, secure chain of custody, pull scheduling, and retrieval/shipping support.
- Commercial Readiness & Supply Process performance qualification and BLA-readiness support, with capacity to scale from clinical lots to commercial demand at the Alameda facility (expandable to 92,000 sq ft) without changing CDMO partners.
Companies that use GeneFab
Customer profileIdeal customer profiles1 record
GeneFab technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability5 records
Feature6 records
GeneFab partnerships and signals
Strategic signalRecent moves6 records
Expansion highlights5 records
GeneFab competitors and assessment
Company assessmentBroad incumbents
- Lonza Cell & Gene: One of the largest global CDMOs offering cell therapy manufacturing, viral vector production, and process development across multiple sites. Directly comparable to GeneFab across CAR-T, viral vector, and process intensification services, but operates at vastly greater scale and with established BLA track records.
- Catalent (Paragon Gene Therapy / Biologics): Major CDMO with deep cell therapy and viral vector capabilities following the Paragon acquisition. Directly comparable to GeneFab in lentiviral vector, AAV, and cell therapy manufacturing, though Catalent offers broader fill/finish and global capacity.
- Charles River Laboratories (Cognate BioServices): Acquired Cognate BioServices to build a cell and gene therapy CDMO offering, with cGMP cell therapy and viral vector manufacturing. Comparable end-to-end service offering to GeneFab, with stronger analytical and global infrastructure.
- Thermo Fisher Scientific (Viral Vector Services): Operates viral vector and cell therapy manufacturing services as part of its pharma services portfolio. Comparable to GeneFab's lentiviral and gamma-retroviral vector manufacturing capabilities, with broader scale and global reach.
Direct peers
- AGC Biologics: CDMO with dedicated cell and gene therapy services including viral vector manufacturing, cell therapy, and process development. Comparable to GeneFab's modality-agnostic CAR/TCR-T, CAR-NK, and iPSC capability set, with similar mid-tier scale.
- Resilience: Technology-focused biomanufacturing company with cell therapy and viral vector capabilities built around modern, modular facilities. Directly comparable to GeneFab's purpose-built, digitally-minded CDMO positioning for advanced therapies.
- Miltenyi Biotec (Cell Therapy CDMO): Offers GMP cell therapy manufacturing services alongside its proprietary cell separation and processing instruments. Comparable to GeneFab in CAR-T and engineered cell therapy manufacturing, with deeper integration into upstream cell processing tools.
Emerging players
- Cellares: Cell therapy automation company offering integrated manufacturing platforms (Cell Shuttle) for autologous and allogeneic cell therapies. Comparable to GeneFab's process intensification thesis but differentiated by closed-system automation rather than open-suite GMP.
- Cellular Origins: Early-stage cell therapy manufacturing automation company targeting scalable, cost-effective CGT production. Comparable as a Bay-Area/UK emerging CGT manufacturing technology company with similar modality-agnostic positioning, though focused on automation rather than service-based CDMO.
- VectorBuilder: CDMO offering custom vector design and viral vector manufacturing (LVV, AAV, adenovirus) with research- and GMP-grade offerings. Comparable to GeneFab's integrated vector design + manufacturing proposition, particularly for in-vivo gene therapy programs.
Market position
Strengths4 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
GeneFab social profiles
Digital presenceGeneFab compliance and trust
Trust signalCompliance3 records
GeneFab financial estimates
Financial estimateRevenue estimate
Valuation estimate
GeneFab leadership team
Management profileNumber of profiles
Profiles12 records
GeneFab funding detail
Funding detailFunding overview
Funding rounds2 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
GeneFab M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about GeneFab
What does GeneFab do?
GeneFab is an integrated cell and gene therapy Contract Research, Development, and Manufacturing Organization (CRDMO) offering end-to-end services spanning synthetic biology construct design, process and analytical development, cGMP cell therapy and viral vector manufacturing, cell banking, QC release, stability, and commercial supply. The platform combines ML-driven genetic design and proprietary cell-specific promoters and drug-induced switches (South San Francisco) with a 42,000 sq ft cGMP facility featuring seven Grade B cleanroom suites (Alameda) to support autologous and allogeneic cell therapy, lentiviral and gamma-retroviral vectors, and in-vivo gene therapy programs.
Is GeneFab a public or private company?
GeneFab is a private company. It is classified as venture growth investor backed and is currently operating.
When was GeneFab founded?
GeneFab was founded in 2023. It employs 51 to 100 people.
Where is GeneFab based?
GeneFab is headquartered in Alameda, United States, in the North America region.
How does GeneFab make money?
Two revenue lines are on record. Contract research, development and manufacturing services (CRDMO) is the primary driver. The others are long-term CRDMO partnership programs.
Who are GeneFab's main competitors?
Broad incumbents on record are Lonza Cell & Gene, Catalent (Paragon Gene Therapy / Biologics), Charles River Laboratories (Cognate BioServices) and Thermo Fisher Scientific (Viral Vector Services). Direct peers are AGC Biologics, Resilience and Miltenyi Biotec (Cell Therapy CDMO). Emerging players are Cellares, Cellular Origins and VectorBuilder.
Does GeneFab have an API?
No public API is recorded for GeneFab.
What industry is GeneFab in?
GeneFab's product category is Cell & Gene Therapy CDMO Services. Its primary akta.pro industry code is HLAGABAE, Gene Therapy (Viral Vector/Plasmid) CDMO, with a secondary code of HLAAACAK, Gene Therapy Analytical Testing & QC (potency, vg/ddPCR, infectivity, RCL/RCA). Its NAICS code is 541714 and its SIC code is 8731.