Commercial-Scale Cell & Gene Therapy CDMOs
59
CDMOs tracked
59
Fully scored
28
With FDA records
102
FDA inspections
319
EMA/MHRA GMP certs
8
Warning letters
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: 47 NAI (no action), 50 VAI (voluntary action), 5 OAI (official action). Leading inspection & GMP sites: United States (84), UNITED KINGDOM (68), Austria (51), Germany (40), Denmark (35).
Last updated 2026-08-22. 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
|
90.8 | 97.0 | 6 insp · 2 GMP | — | 583 programs |
| 2 |
Novartis
Basel, Switzerland
|
88.3 | 90.9 | 15 insp · 62 GMP | — | 135 programs |
| 3 |
COH
City of Hope (T Cell Manufacturing)
Duarte, CA
|
83.8 | 96.8 | 3 insp · 0 GMP | — | 211 programs |
| 4 |
TF
Thermo Fisher Scientific
Plainville, MA · Alachua, FL · Cambridge, MA
|
83.1 | 97.9 | 6 insp · 10 GMP | Available | 2 programs |
| 5 |
MK
Merck KGaA / MilliporeSigma (CDMO)
Darmstadt, DE · St. Louis, MO
|
81.8 | 98.6 | 2 insp · 2 GMP | — | 22 programs |
| 6 |
AG
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
|
80.6 | 99.9 | 2 insp · 23 GMP | Available | 2 programs |
| 7 |
TK
Takeda
Boston, MA · Zurich, CH
|
80.5 | 99.3 | 4 insp · 18 GMP | — | 100 programs |
| 8 |
BY
Bayer (Cell Therapy Mfg)
Berkeley, CA
|
79.2 | 86.9 | 8 insp · 17 GMP | — | 126 programs |
| 9 |
CS
Cedars-Sinai Biomanufacturing
Los Angeles, CA
|
78.9 | 100.0 | 1 insp · 0 GMP | — | 34 programs |
| 10 |
Lonza
Basel, Switzerland
|
78.2 | 95.1 | 2 insp · 8 GMP | — | 1 programs |
| 11 |
OX
Oxford Biomedica
Oxford, United Kingdom
|
77.1 | 100.0 | 0 insp · 13 GMP | Available | 7 programs |
| 12 |
CI
Cincinnati Children's Vector Production Facility
Cincinnati, OH
|
75.2 | 100.0 | 1 insp · 0 GMP | — | 1 programs |
| 13 |
MB
Miltenyi Biotec
Bergisch Gladbach, Germany
|
74.6 | 100.0 | 0 insp · 2 GMP | — | 8 programs |
| 14 |
NR
National Resilience
San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA
|
73.4 | 97.7 | 1 insp · 0 GMP | Available | 9 programs |
| 15 |
CR
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
|
91.7 | 98.7 | 8 insp · 11 GMP | Limited | 0 programs |
| 16 |
RP
ReciBioPharm
Keele, UK · Sodertalje, SE
|
88.0 | 100.0 | 0 insp · 3 GMP | — | 0 programs |
| 17 |
PB
Pharmaron Biologics
San Diego, CA · Shaoxing, China, Liverpool, UK, Ningbo China
|
86.9 | 100.0 | 3 insp · 0 GMP | Available | 0 programs |
| 18 |
AJ
Ajinomoto Bio-Pharma Services
San Diego, CA · Osaka, JP
|
85.6 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 19 |
LB
Lotte Biologics
Incheon, KR · Syracuse, NY
|
83.7 | 100.0 | 1 insp · 0 GMP | — | 0 programs |
| 20 |
WB2
WuXi Biologics
Shanghai, CN · Wuxi, CN
|
83.7 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 21 |
KB
KBI Biopharma
Durham, NC · Boulder, CO
|
83.5 | 100.0 | 1 insp · 1 GMP | Limited | 0 programs |
| 22 |
FD
FUJIFILM Diosynth Biotechnologies
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
|
83.5 | 100.0 | 0 insp · 23 GMP | 0 programs | |
| 23 |
MN
Minaris Advanced Therapies
Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
|
83.5 | 100.0 | 1 insp · 6 GMP | Limited | 0 programs |
| 24 |
SC
SCTbio
Prague, Czech Republic
|
81.6 | 100.0 | 0 insp · 5 GMP | — | 0 programs |
| 25 |
EF
Eurofins CDMO
Planegg, DE · San Diego, CA
|
81.6 | 100.0 | 5 insp · 0 GMP | — | 0 programs |
| 26 |
DH
Danaher (CGT Portfolio)
Washington, DC
|
81.5 | — | — | — | 0 programs |
| 27 |
BR
BioReliance (Merck)
Glasgow, UK · Rockville, MD
|
81.0 | 98.8 | 4 insp · 8 GMP | — | 0 programs |
| 28 |
NW
Northway Biotech
Vilnius, LT; Waltham (MA), USA
|
80.8 | 100.0 | 0 insp · 8 GMP | Available | 0 programs |
| 29 |
CF
CELLforCURE (SEQENS)
Les Ulis, FR
|
80.3 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 30 |
RC
RoslinCT
Edinburgh, UK · Hopkinton, MA
|
80.2 | 98.8 | 1 insp · 1 GMP | Available | 0 programs |
| 31 |
SG
Syngene International
Bengaluru, India
|
79.7 | 95.9 | 2 insp · 0 GMP | — | 0 programs |
| 32 |
OB
OmniaBio
Hamilton, ON
|
79.5 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 33 |
GS
GenScript ProBio
Piscataway, NJ · Nanjing, CN
|
79.5 | 100.0 | — | Constrained | 0 programs |
| 34 |
SK
SK pharmteco
Dublin, Ireland. Rancho Cordova, CA. King of Prussia, PA. Houston, TX. Korea. France.
|
79.5 | 100.0 | — | Available | 0 programs |
| 35 |
PG
ProBioGen
Berlin, DE
|
78.9 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 36 |
XP
eXmoor Pharma
Bristol, United Kingdom
|
78.7 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 37 |
BB
bluebird bio Manufacturing
Durham, NC
|
78.5 | — | — | — | 0 programs |
| 38 |
AA
Ascend Advanced Therapies
London, United Kingdom
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 39 |
NG
NecstGen
Leiden, NL
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 40 |
ET
Exothera
Jumet, BE
|
78.1 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 41 |
OR
Ori Biotech
London, UK
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 42 |
CC
CCRM
Toronto, ON, Canada
|
78.1 | 100.0 | 5 insp · 0 GMP | — | 0 programs |
| 43 |
CE
Celonic
Basel, Switzerland
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 44 |
AD
Advent Bioservices
London, United Kingdom
|
78.1 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 45 |
GP
Green Phoenix Labs
San Diego, CA
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 46 |
BV
Biovian
Turku, Finland
|
78.0 | 99.7 | 1 insp · 4 GMP | — | 0 programs |
| 47 |
AG2
August Bioservices
San Carlos, CA
|
77.4 | 98.5 | 1 insp · 0 GMP | — | 0 programs |
| 48 |
BC
Biocon Biologics
Bangalore, India
|
77.1 | 96.1 | 4 insp · 2 GMP | — | 0 programs |
| 49 |
VG
Viralgen Vector Core
San Sebastián, Spain
|
76.8 | 100.0 | 0 insp · 4 GMP | Available | 0 programs |
| 50 |
SY
Symbiosis Pharmaceutical Services
Stirling, United Kingdom
|
76.8 | 100.0 | 1 insp · 9 GMP | — | 0 programs |
| 51 |
IP
Intas Pharmaceuticals
Ahmedabad, India
|
76.8 | 100.0 | 0 insp · 5 GMP | — | 0 programs |
| 52 |
CY
Cell-Easy
Toulouse, FR
|
76.8 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 53 |
CN
Cellin Technologies
Luxembourg, LU
|
76.8 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 54 |
HH
HiTech Health
London, United Kingdom
|
76.8 | 100.0 | 0 insp · 9 GMP | — | 0 programs |
| 55 |
Catalent
Bagsværd, Denmark (operating under Novo Holdings; legacy US operations headquartered in Somerset, NJ)
|
76.5 | 79.3 | 12 insp · 35 GMP | — | 0 programs |
| 56 |
FH
Fred Hutch Cell Therapy Lab
Seattle, WA
|
76.4 | — | — | — | 453 programs |
| 57 |
CA
Catalent (Novo Holdings)
Harmans, MD · Gosselies, BE
|
75.1 | 79.3 | 1 insp · 0 GMP | Available | 0 programs |
| 58 |
IO
Iovance Biotherapeutics (Mfg)
Philadelphia, PA
|
70.8 | — | — | — | 31 programs |
| 59 |
IU
Indiana University Vector Production Facility
Indianapolis, IN
|
66.2 | — | — | — | 49 programs |
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 28 Cell & Gene Therapy CDMOs with FDA inspection records and 319 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.
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