Best Cell & Gene Therapy CDMOs by Signal Score

· updated as new inspection, certificate, and trial data enters the platform
← All Cell & Gene Therapy CDMOs Best Clean FDA History Commercial Scale
Region: USA Europe Asia UK India Switzerland Germany South Korea Japan China
10
CDMOs tracked
10
Fully scored
9
With FDA records
48
FDA inspections
153
EMA/MHRA GMP certs

Cell and gene therapy manufacturing spans two adjacent product classes: living cell products (CAR-T, TCR, NK, stem cell therapies) and the viral vectors used to genetically modify them (AAV, lentiviral, adenoviral). The two are tightly coupled in ex vivo cell engineering — a lentiviral vector CDMO supplies the vector that a cell therapy CDMO uses to modify patient T cells for CAR-T. Sponsors running integrated programs benefit from CDMOs covering both, and the ranking below aggregates that combined view.

For platform-specific rankings, use the dedicated pages: <a href="/modality/cell-therapy">Cell Therapy CDMOs</a>, <a href="/modality/aav">AAV CDMOs</a>, <a href="/modality/lentiviral">Lentiviral Vector CDMOs</a>, <a href="/modality/adenoviral">Adenoviral Vector CDMOs</a>, <a href="/modality/gene-therapy">Gene Therapy CDMOs</a> (vectors only, no cell processing).

FDA inspection outcomes across these CDMOs: 23 NAI (no action), 22 VAI (voluntary action), 3 OAI (official action). Leading inspection & GMP sites: Austria (56), United States (41), Germany (24), UNITED KINGDOM (20), Denmark (18).

Last updated 2026-09-23. Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.

# CDMO Signal Score Quality FDA · GMP Capacity Programs
1
BMS
Bristol Myers Squibb (CGT Mfg)
Bothell, WA · Warren, NJ
 91.1 97.9 6 insp · 2 GMP — 585 programs
2
Novartis
Basel, Switzerland
 87.1 93.1 16 insp · 67 GMP — 135 programs
3
COH
City of Hope (T Cell Manufacturing)
Duarte, CA
 83.9 97.1 3 insp · 0 GMP — 213 programs
4
TK
Takeda
Boston, MA · Zurich, CH
 81.9 99.6 4 insp · 18 GMP — 100 programs
5
MK
Merck KGaA / MilliporeSigma (CDMO)
Darmstadt, DE · St. Louis, MO
 81.8 98.7 2 insp · 2 GMP — 22 programs
6
TF
Thermo Fisher Scientific
Plainville, MA · Alachua, FL · Cambridge, MA
 81.0 100.0 6 insp · 10 GMP Available 2 programs
7
BY
Bayer (Cell Therapy Mfg)
Berkeley, CA
 80.4 90.1 8 insp · 18 GMP — 126 programs
8
CS
Cedars-Sinai Biomanufacturing
Los Angeles, CA
 79.8 100.0 1 insp · 0 GMP — 34 programs
9
AG
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
 78.6 100.0 2 insp · 23 GMP Available 2 programs
10
OX
Oxford Biomedica
Oxford, United Kingdom
 76.2 100.0 0 insp · 13 GMP Available 7 programs
How we score CDMOs →

What to evaluate in a Cell & Gene Therapy CDMO

Integrated vs point-solution CDMO
Ex vivo cell therapy programs benefit from CDMOs handling both vector and cell processing under one roof. Point-solution CDMOs specialize deeper but add tech-transfer complexity.
Regulatory record by process class
Cell therapy and viral vector inspections are separately scoped. Verify the CDMO's inspection record on the specific process class your program will use.
Chain-of-identity + cold chain
Autologous cell therapy demands per-patient scheduling, batch-of-one tracking, and cold-chain logistics that CDMOs vary meaningfully on. Confirm the CDMO's chain-of-identity software and cryopreservation posture.
Commercial track record
For late-stage programs, CDMOs with commercial-approved cell or gene therapy products on file carry demonstrable posture that ranking algorithms only partially capture.

Cell & Gene Therapy CDMOs — Frequently Asked Questions

Who are the top Cell & Gene Therapy CDMOs?
By CDMO Signal's independent Signal Score, the top-ranked Cell & Gene Therapy CDMOs include Bristol Myers Squibb (CGT Mfg), Novartis, City of Hope (T Cell Manufacturing). See the full ranked table above — scored on FDA, clinical, financial, and capacity data.
How many Cell & Gene Therapy CDMOs have FDA inspection records?
CDMO Signal tracks 9 Cell & Gene Therapy CDMOs with FDA inspection records and 153 EMA/MHRA GMP certificates across the group.
What should I look for in a cell and gene therapy CDMO?
Start with process class match — cell therapy vs vector vs both. For ex vivo programs benefit from integrated CDMOs. Verify inspection record on the specific process class, confirm capacity match to your patient volume, and prioritize CDMOs with commercial-scale posture for late-stage work.
How many cell and gene therapy CDMOs does CDMO Signal track?
109 CDMOs are tracked as cell or gene therapy manufacturers — the union of cell therapy, AAV, lentiviral, adenoviral, and gene therapy-tagged CDMOs. This is the broadest advanced-therapy candidate list on our platform.
Related modalities
Cell Therapy CDMOs AAV / Gene Therapy CDMOs Lentiviral Vector CDMOs Gene Therapy CDMOs
Other Modalities
AAV CAR-T Lentiviral Cell Therapy mRNA/LNP Plasmid DNA Biologics Oligo/ASO Adenoviral Gene Editing Exosome Recombinant Proteins ADC Gene Therapy Viral Vector