GeneFab cGMP cleanroom
Cell & Gene Therapy CRDMO  ·  Bay Area, USA

Together, we bring
breakthrough therapies
to patients.

At the intersection of genetic design
— an integrated partner for the world's most ambitious cell & gene therapy programs.

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What drives us

Patients are waiting.
We're here to help
innovators get them what they need — faster.

Cell & gene therapies are rewriting the rules of medicine. Behind every novel construct, every viral vector, every dose released to the clinic is a team of people racing against biology, regulation, and time.

GeneFab was built to be the partner that makes that race winnable. Not a vendor that executes from arm's length, but a co-development team that has lived on the innovator side of the table — and brings every learning from every program forward into the next.

We do this because the people developing these therapies are doing the most important work in medicine today. Our job is to remove every operational, technical, and regulatory obstacle between their science and the patients who need it.

0+ years Operating in cell, gene & nucleic acid therapy development
0+ lots cGMP cell therapy batches manufactured to date
42k sq ft Of cGMP space today — expandable to 92K sq ft for future growth
0% aseptic Open & closed-system aseptic processing success rate

Why GeneFab.

Four things our partners say sets us apart — drawn directly from the people who build the programs every day.

01

Co-development, not execution.

You don't hand us a process and wait for results. We map your goals — yield, robustness, CQAs, COGS — and work backwards into a study plan, with you in the room at every gate.

"We develop alongside you and your needs on the journey toward clinical and commercial production."
Annie Chiu  · 
Associate Director, Cell Therapy PD
02

We've been on your side of the table.

Many of us came from innovator-side companies before joining GeneFab. We know the urgency, the runway pressure, the regulatory calendar — because we've lived it.

"What's great is we come with different sets of expertise — and instead of having those clash, we have them coming together."
Girar Kolakian  · 
Director, Manufacturing & MSAT
03

One roof. One team.

Synthetic biology, process development, manufacturing, analytical, and quality — everyone is steps away. Issues that would take a week of inter-vendor email at a bigger CDMO get resolved in an afternoon here.

"We're a tight-knit team. When an issue arises, we all come together — and we work fast."
Megan Ramirez  · 
Director of QC, Microbiology
04

Transparent by design.

Most CDMOs are a black box. We share Gantt charts, data packages, and process information in real time — and we're building toward live-batch visibility, so you can see what's happening on our floor without leaving your desk.

"We dig through the gaps together."
Girar Kolakian  · 
Director, Manufacturing & MSAT

Advanced therapies,
powered together.

We're modality-agnostic by design — built for the cell & gene therapy field's full breadth. Our integrated SynBio research, in-vivo gene therapy expertise, and ex-vivo cell therapy manufacturing meet under one roof.

Ex Vivo Cell Therapy

End-to-end autologous & allogeneic workflows — CAR-T, TCR-T, CAR-NK, Treg, iPSC, and others. Multiple expansion platforms tuned to your modality.

CAR/TCR-TCAR-NKTreg

In Vivo Cell Therapy

The vehicle is the therapy. We design the construct, engineer cell-specific promoters, and manufacture the lentiviral vector that delivers it — directly to patients, no ex-vivo step required.

In vivo CAR-TTargeted LVVCell-specific promoters

Viral Vectors

The engine for both modalities — lentivirus & gamma-retrovirus production from adherent (2-20 L) to suspension GMP (50-200 L). The same vector platform feeds ex-vivo cell therapy and in-vivo dosing.

LVVGRVAdherent + SuspensionStable producer lines

Synthetic Biology

Proprietary building blocks for next-gen therapies — cell-specific promoters, kill switches, custom producer cell lines.

PromotersKill switchesRegulatory elements
FROM DESIGN TO DRUG PRODUCT

One integrated handoff.

Cell & gene therapy is rarely linear. We treat the journey — from genetic design and R&D, through IND-enabling and clinical, to commercial supply — as one continuous platform. Below are the capabilities that platform stitches together, not stops along a conveyor belt.

Step 01
Genetic Design
South San Francisco
Construct architecture, payload optimization, cell-specific promoters, kill switches, and ML-driven sequence design.
Step 02
Process Development
Alameda
Scale-up, optimization, and lock-in. Unit operations tuned to the product, not the other way around.
Step 03
Analytical Development
Alameda
Method development, qualification, and transfer. Assays ready when your process is — no waiting on outsourced labs.
Step 04
cGMP Manufacturing
Alameda · 7 suites
Cell therapy drug product and viral vector starting material. FDA & EU GMP standards, validated equipment, trained operators.
Step 05
QC & Release
Alameda · in-house
Qualified methods running on a regular cadence. Phase-appropriate quality, right the first time — release in days, not weeks.
Step 06
Commercial Readiness & Supply
Alameda · expandable to 92K sq ft
Process performance qualification, BLA-readiness, and the capacity to scale from clinical lots to commercial demand without changing partners.
Feedback loop

Manufacturing informs design.

Process learnings flow backward — manufacturability constraints become design inputs for the next construct, not afterthoughts.

Same building

One team, one floor.

PD scientists, AD analysts, GMP operators, and QC release sit in the same facility. The handshake between stages is a conversation, not a tech package.

R&D through commercial

One partner across the lifecycle.

Programs evolve from research-scale exploration to commercial-scale supply. We support you across that full arc — minimizing the costly handoffs between vendors, sites, and stages.

A different quality philosophy

At GeneFab, our team aims to get you to the clinic faster — by getting things right the first time, and never being afraid to improve when something can be better.

Quality is driven by GeneFab culture. Every department is responsible for the quality and safety of the product — the product that's taken by the patient.

Vadim Eristavi
Chief Quality Officer  ·  28+ years in quality systems & cell therapy