Cell Therapy CDMOs with Clean FDA Inspection History
· updated as new inspection, certificate, and trial data enters the platform
33
CDMOs tracked
33
Fully scored
18
With FDA records
57
FDA inspections
134
EMA/MHRA GMP certs
Cell therapy CDMOs manufacture living products — CAR-T, TCR, NK, and stem-cell therapies — where the process is the product. Autologous programs add patient-scheduling and chain-of-identity demands that allogeneic, batch-based programs avoid.
The right cell therapy CDMO depends on autologous vs allogeneic experience, vector sourcing, closed-system processing, and cold-chain logistics. The rankings below score each CDMO on FDA inspections, GMP certification, clinical activity, and capacity.
FDA inspection outcomes across these CDMOs: 30 NAI (no action), 26 VAI (voluntary action), 1 OAI (official action). Leading inspection & GMP sites: United States (46), Germany (31), UNITED KINGDOM (22), Denmark (18), Ireland (17).
Last updated 2026-10-06. 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 |
COH
City of Hope (T Cell Manufacturing)
Duarte, CA
|
83.9 | 97.1 | 3 insp · 0 GMP | — | 213 programs |
| 3 |
TK
Takeda
Boston, MA · Zurich, CH
|
81.9 | 99.6 | 4 insp · 18 GMP | — | 100 programs |
| 4 |
MK
Merck KGaA / MilliporeSigma (CDMO)
Darmstadt, DE · St. Louis, MO
|
81.8 | 98.7 | 2 insp · 2 GMP | — | 22 programs |
| 5 |
BY
Bayer (Cell Therapy Mfg)
Berkeley, CA
|
80.4 | 90.1 | 8 insp · 18 GMP | — | 126 programs |
| 6 |
CS
Cedars-Sinai Biomanufacturing
Los Angeles, CA
|
79.8 | 100.0 | 1 insp · 0 GMP | — | 34 programs |
| 7 |
AG
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
|
78.6 | 100.0 | 2 insp · 23 GMP | Available | 2 programs |
| 8 |
Lonza
Basel, Switzerland
|
76.0 | 95.7 | 2 insp · 8 GMP | — | 1 programs |
| 9 |
NR
National Resilience
San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA
|
74.5 | 98.0 | 1 insp · 0 GMP | Available | 9 programs |
| 10 |
MB
Miltenyi Biotec
Bergisch Gladbach, Germany
|
73.0 | 100.0 | 0 insp · 2 GMP | — | 8 programs |
| 11 |
CR
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
|
90.9 | 98.3 | 8 insp · 11 GMP | Limited | 0 programs |
| 12 |
MN
Minaris Advanced Therapies
Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
|
83.3 | 99.6 | 1 insp · 6 GMP | Limited | 0 programs |
| 13 |
WB2
WuXi Biologics
Shanghai, CN · Wuxi, CN
|
82.9 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 14 |
SC
SCTbio
Prague, Czech Republic
|
81.6 | 100.0 | 0 insp · 5 GMP | — | 0 programs |
| 15 |
EF
Eurofins CDMO
Planegg, DE · San Diego, CA
|
81.6 | 100.0 | 5 insp · 0 GMP | — | 0 programs |
| 16 |
RC
RoslinCT
Edinburgh, UK · Hopkinton, MA
|
80.3 | 99.0 | 1 insp · 1 GMP | Available | 0 programs |
| 17 |
CF
CELLforCURE (SEQENS)
Les Ulis, FR
|
80.3 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 18 |
OB
OmniaBio
Hamilton, ON
|
79.5 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 19 |
GS
GenScript ProBio
Piscataway, NJ · Nanjing, CN
|
79.5 | 100.0 | — | Constrained | 0 programs |
| 20 |
SK
SK pharmteco
Dublin, Ireland. Rancho Cordova, CA. King of Prussia, PA. Houston, TX. Korea. France.
|
79.5 | 100.0 | — | Available | 0 programs |
| 21 |
SG
Syngene International
Bengaluru, India
|
78.5 | 96.3 | 2 insp · 0 GMP | — | 0 programs |
| 22 |
NG
NecstGen
Leiden, NL
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 23 |
OR
Ori Biotech
London, United Kingdom
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 24 |
CC
CCRM
Toronto, ON, Canada
|
78.1 | 100.0 | 5 insp · 0 GMP | — | 0 programs |
| 25 |
CE
Celonic
Basel, Switzerland
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 26 |
XP
eXmoor Pharma
Bristol, United Kingdom
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 27 |
GP
Green Phoenix Labs
San Diego, CA
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 28 |
BC
Biocon Biologics
Bengaluru, India
|
77.6 | 97.1 | 4 insp · 2 GMP | — | 0 programs |
| 29 |
SY
Symbiosis Pharmaceutical Services
Stirling, United Kingdom
|
76.8 | 100.0 | 1 insp · 9 GMP | — | 0 programs |
| 30 |
CY
Cell-Easy
Toulouse, FR
|
76.8 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 31 |
CN
Cellin Technologies
Luxembourg, LU
|
76.8 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 32 |
HH
HiTech Health
London, United Kingdom
|
76.8 | 100.0 | 0 insp · 9 GMP | — | 0 programs |
| 33 |
LZ
Lonza Biologics
Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
|
73.0 | 95.7 | 1 insp · 0 GMP | Limited | 0 programs |
What to evaluate in a Cell Therapy CDMO
Autologous vs allogeneic
Autologous needs per-patient scheduling, chain-of-identity, and short turnaround; allogeneic needs scalable batch processing and a master cell bank strategy. Pick a CDMO proven in your model.
Vector & raw materials
Most cell therapies need a viral vector. Confirm whether the CDMO makes vector in-house or coordinates an external supplier, and how that affects timelines.
Closed-system & cleanrooms
Closed, automated processing reduces contamination risk and labor. Ask about cleanroom grade, automation platforms, and parallel-suite capacity.
Cold chain & logistics
Cryopreservation and chain-of-custody are critical for living cells. Evaluate the CDMO's cold-chain and apheresis-to-infusion logistics.
Cell Therapy CDMOs — Frequently Asked Questions
Who are the top Cell Therapy CDMOs?
By CDMO Signal's independent Signal Score, the top-ranked Cell Therapy CDMOs include Bristol Myers Squibb (CGT Mfg), City of Hope (T Cell Manufacturing), Takeda. See the full ranked table above — scored on FDA, clinical, financial, and capacity data.
How many Cell Therapy CDMOs have FDA inspection records?
CDMO Signal tracks 18 Cell Therapy CDMOs with FDA inspection records and 134 EMA/MHRA GMP certificates across the group.
What should I look for in a cell therapy CDMO?
Match the CDMO to your model: autologous needs chain-of-identity and fast turnaround; allogeneic needs scalable batch processing. Confirm vector sourcing, closed-system processing, cold-chain logistics, and a clean FDA and EMA/MHRA record.
Do cell therapy CDMOs make their own viral vectors?
Some do in-house; others coordinate an external vector supplier. In-house vector can shorten timelines and simplify supply, but a strong external partner is common. Check each profile's modality coverage above.
Related modalities