Founded in 2023 specifically to address innovators' needs in cell & gene
therapy design and manufacturing — we're not a vendor that executes from arm's length. We are a co-development team from discovery to manufacturing that has lived on the innovator side of the table, and brings every learning from every program forward into the next.
Three things every program with us reflects — drawn from how our scientists and operators describe their own work.
Strategic decision-making that drives results — for innovators on the critical path to clinic. Phase-appropriate, adaptable, never one-size-fits-all.
Trust and relationships first. Open project management, transparent data sharing, dedicated PMO — every relevant data point shared so you can decide with confidence.
Dedicated to excellence and quality. We scale with you from discovery through commercial — the same teams, the same process knowledge, end to end.
When you partner with GeneFab, you're not picking a development shop you'll have to leave later. Our senior leadership has a clear roadmap to take programs through clinical trials and into commercial supply — and we're investing in the systems, capacity, and quality infrastructure to get there with you.
Avoid picking a Phase 1 CDMO you will outgrow — most sponsors face costly, time-consuming repeat tech transfers. Our fully integrated process under one roof and expandable facility to 92K sq ft offers growth through commercialization.
Quality is driven by senior management. So is your program. Strategic decisions, escalations, and roadmap reviews include the people who actually own the company's direction — not just project managers.
Fully electronic quality and document control systems being implemented across 2026–2027 to support FDA pre-approval inspections as our partner programs move toward BLA.
Brand-new 42,000 sq ft cGMP facility in Alameda, opened 2023. Seven ISO 7 / Grade B suites, modern aseptic processing, and an experienced personnel-led operation — not retrofitted legacy infrastructure.
