Cell Therapy CDMOs with Clean FDA Inspection History
34
CDMOs tracked
34
Fully scored
18
With FDA records
57
FDA inspections
138
EMA/MHRA GMP certs
6
Warning letters
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 (30), UNITED KINGDOM (22), Denmark (18), Ireland (17).
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 |
COH
City of Hope (T Cell Manufacturing)
Duarte, CA
|
83.8 | 96.8 | 3 insp · 0 GMP | — | 211 programs |
| 3 |
MK
Merck KGaA / MilliporeSigma (CDMO)
Darmstadt, DE · St. Louis, MO
|
81.8 | 98.6 | 2 insp · 2 GMP | — | 22 programs |
| 4 |
AG
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
|
80.6 | 99.9 | 2 insp · 23 GMP | Available | 2 programs |
| 5 |
TK
Takeda
Boston, MA · Zurich, CH
|
80.5 | 99.3 | 4 insp · 18 GMP | — | 100 programs |
| 6 |
BY
Bayer (Cell Therapy Mfg)
Berkeley, CA
|
79.2 | 86.9 | 8 insp · 17 GMP | — | 126 programs |
| 7 |
CS
Cedars-Sinai Biomanufacturing
Los Angeles, CA
|
78.9 | 100.0 | 1 insp · 0 GMP | — | 34 programs |
| 8 |
Lonza
Basel, Switzerland
|
78.2 | 95.1 | 2 insp · 8 GMP | — | 1 programs |
| 9 |
MB
Miltenyi Biotec
Bergisch Gladbach, Germany
|
74.6 | 100.0 | 0 insp · 2 GMP | — | 8 programs |
| 10 |
NR
National Resilience
San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA
|
73.4 | 97.7 | 1 insp · 0 GMP | Available | 9 programs |
| 11 |
CR
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
|
91.7 | 98.7 | 8 insp · 11 GMP | Limited | 0 programs |
| 12 |
WB2
WuXi Biologics
Shanghai, CN · Wuxi, CN
|
83.7 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 13 |
MN
Minaris Advanced Therapies
Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
|
83.5 | 100.0 | 1 insp · 6 GMP | Limited | 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 |
CF
CELLforCURE (SEQENS)
Les Ulis, FR
|
80.3 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 17 |
RC
RoslinCT
Edinburgh, UK · Hopkinton, MA
|
80.2 | 98.8 | 1 insp · 1 GMP | Available | 0 programs |
| 18 |
SG
Syngene International
Bengaluru, India
|
79.7 | 95.9 | 2 insp · 0 GMP | — | 0 programs |
| 19 |
OB
OmniaBio
Hamilton, ON
|
79.5 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 20 |
GS
GenScript ProBio
Piscataway, NJ · Nanjing, CN
|
79.5 | 100.0 | — | Constrained | 0 programs |
| 21 |
SK
SK pharmteco
Dublin, Ireland. Rancho Cordova, CA. King of Prussia, PA. Houston, TX. Korea. France.
|
79.5 | 100.0 | — | Available | 0 programs |
| 22 |
XP
eXmoor Pharma
Bristol, United Kingdom
|
78.7 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 23 |
NG
NecstGen
Leiden, NL
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 24 |
OR
Ori Biotech
London, UK
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 25 |
CC
CCRM
Toronto, ON, Canada
|
78.1 | 100.0 | 5 insp · 0 GMP | — | 0 programs |
| 26 |
CE
Celonic
Basel, Switzerland
|
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
Bangalore, India
|
77.1 | 96.1 | 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 |
IP
Intas Pharmaceuticals
Ahmedabad, India
|
76.8 | 100.0 | 0 insp · 5 GMP | — | 0 programs |
| 31 |
CY
Cell-Easy
Toulouse, FR
|
76.8 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 32 |
CN
Cellin Technologies
Luxembourg, LU
|
76.8 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 33 |
HH
HiTech Health
London, United Kingdom
|
76.8 | 100.0 | 0 insp · 9 GMP | — | 0 programs |
| 34 |
LZ
Lonza Biologics
Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
|
72.8 | 95.1 | 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), Merck KGaA / MilliporeSigma (CDMO). 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 138 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