Commercial-Scale Cell Therapy CDMOs

36
CDMOs tracked
36
Fully scored
17
With FDA records
51
FDA inspections
136
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: 25 NAI (no action), 25 VAI (voluntary action), 1 OAI (official action). Leading inspection & GMP sites: United States (41), Germany (29), UNITED KINGDOM (22), Denmark (18), Ireland (16).

Last updated 2026-06-24. Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.

# CDMO Signal Score Quality FDA · GMP Capacity Programs
1
CR
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
91.7 98.7 7 insp · 11 GMP Limited 0 programs
2
BMS
Bristol Myers Squibb (CGT Mfg)
Bothell, WA · Warren, NJ
90.8 97.0 5 insp · 2 GMP 576 programs
3
COH
City of Hope (T Cell Manufacturing)
Duarte, CA
83.8 96.8 3 insp · 0 GMP 207 programs
4
WB2
WuXi Biologics
Shanghai, CN · Wuxi, CN
83.7 100.0 0 insp · 4 GMP 0 programs
5
MN
Minaris Advanced Therapies
Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
83.5 100.0 1 insp · 6 GMP Limited 0 programs
6
MK
Merck KGaA / MilliporeSigma (CDMO)
Darmstadt, DE · St. Louis, MO
81.8 98.6 2 insp · 2 GMP 22 programs
7
SC
SCTbio
Prague, Czech Republic
81.6 100.0 0 insp · 5 GMP 0 programs
8
EF
Eurofins CDMO
Planegg, DE · San Diego, CA
81.6 100.0 4 insp · 0 GMP 0 programs
9
DH
Danaher (CGT Portfolio)
Washington, DC
81.5 0 programs
10
AG
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
80.6 99.9 1 insp · 23 GMP Available 2 programs
11
TK
Takeda
Boston, MA · Zurich, CH
80.5 99.3 3 insp · 18 GMP 100 programs
12
CF
CELLforCURE (SEQENS)
Les Ulis, FR
80.3 100.0 0 insp · 4 GMP 0 programs
13
RC
RoslinCT
Edinburgh, UK · Hopkinton, MA
80.2 98.8 1 insp · 1 GMP Available 0 programs
14
SG
Syngene International
Bangalore, India
79.7 95.9 2 insp · 0 GMP 0 programs
15
OB
OmniaBio
Hamilton, ON
79.5 100.0 0 insp · 2 GMP 0 programs
16
GS
GenScript ProBio
Piscataway, NJ · Nanjing, CN
79.5 100.0 Constrained 0 programs
17
BY
Bayer (Cell Therapy Mfg)
Berkeley, CA
79.2 86.9 8 insp · 16 GMP 125 programs
18
CS
Cedars-Sinai Biomanufacturing
Los Angeles, CA
78.9 100.0 1 insp · 0 GMP 31 programs
19
XP
eXmoor Pharma
Bristol, UK
78.7 100.0 0 insp · 1 GMP 0 programs
20
BB
bluebird bio Manufacturing
Durham, NC
78.5 0 programs
21
Lonza
Basel, Switzerland
78.2 95.1 2 insp · 8 GMP 1 programs
22
NG
NecstGen
Leiden, NL
78.1 100.0 0 insp · 1 GMP 0 programs
23
OR
Ori Biotech
London, UK
78.1 100.0 0 insp · 1 GMP 0 programs
24
CC
CCRM
Toronto, ON
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
GP
Green Phoenix Labs
San Diego, CA
78.1 100.0 0 insp · 1 GMP 0 programs
27
BC
Biocon Biologics
Bangalore, India
77.1 96.1 4 insp · 1 GMP 0 programs
28
SY
Symbiosis Pharmaceutical Services
Stirling, UK
76.8 100.0 1 insp · 9 GMP 0 programs
29
IP
Intas Pharmaceuticals
Ahmedabad, IN
76.8 100.0 0 insp · 5 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, UK
76.8 100.0 0 insp · 9 GMP 0 programs
33
FH
Fred Hutch Cell Therapy Lab
Seattle, WA
76.4 450 programs
34
MB
Miltenyi Biotec
Bergisch Gladbach, Germany
74.6 100.0 0 insp · 2 GMP 8 programs
35
NR
National Resilience
San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA
73.4 97.7 1 insp · 0 GMP Available 9 programs
36
IO
Iovance Biotherapeutics (Mfg)
Philadelphia, PA
70.8 29 programs
How we score CDMOs →

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 Charles River Laboratories, Bristol Myers Squibb (CGT Mfg), City of Hope (T Cell Manufacturing). 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 17 Cell Therapy CDMOs with FDA inspection records and 136 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
Lentiviral Vector CDMOs CAR-T CDMOs Gene Editing CDMOs
Other Modalities
AAV CAR-T Lentiviral mRNA/LNP Plasmid DNA Biologics Oligo/ASO Adenoviral Gene Editing Exosome Recombinant Proteins ADC