Best Cell Therapy CDMOs in United States
· updated as new inspection, certificate, and trial data enters the platform
31
CDMOs tracked
31
Fully scored
13
With FDA records
43
FDA inspections
82
EMA/MHRA GMP certs
For US-manufactured cell therapy programs, Bristol Myers Squibb (CGT Mfg), City of Hope (T Cell Manufacturing), and Takeda lead CDMO Signal's ranking of cell therapy CDMOs with confirmed US facilities. Filtered from the global directory of 64 scored cell therapy CDMOs to 8 with US manufacturing presence. US-based manufacturing carries specific advantages for sponsors filing under FDA jurisdiction: FDA inspection records — which form the core of the Signal Score's Quality Compliance pillar — apply directly, and QP release complexity common to EU-manufactured material does not apply. Rankings update as new inspection and certificate data enters the platform. Full methodology at cdmosignal.com/methodology.
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: 23 NAI (no action), 19 VAI (voluntary action), 1 OAI (official action). Leading inspection & GMP sites: United States (38), Germany (27), Denmark (18), Austria (9), Ireland (9).
Last updated 2026-09-15. 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 |
NR
National Resilience
San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA
|
74.5 | 98.0 | 1 insp · 0 GMP | Available | 9 programs |
| 9 |
CR
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
|
90.9 | 98.3 | 8 insp · 11 GMP | Limited | 0 programs |
| 10 |
MN
Minaris Advanced Therapies
Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
|
83.3 | 99.6 | 1 insp · 6 GMP | Limited | 0 programs |
| 11 |
EF
Eurofins CDMO
Planegg, DE · San Diego, CA
|
81.6 | 100.0 | 5 insp · 0 GMP | — | 0 programs |
| 12 |
DH
Danaher (CGT Portfolio)
Washington, DC
|
81.5 | — | — | — | 0 programs |
| 13 |
RC
RoslinCT
Edinburgh, UK · Hopkinton, MA
|
80.3 | 99.0 | 1 insp · 1 GMP | Available | 0 programs |
| 14 |
GS
GenScript ProBio
Piscataway, NJ · Nanjing, CN
|
79.5 | 100.0 | — | Constrained | 0 programs |
| 15 |
BB
bluebird bio Manufacturing
Durham, NC
|
78.5 | — | — | — | 0 programs |
| 16 |
GP
Green Phoenix Labs
San Diego, CA
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 17 |
FH
Fred Hutch Cell Therapy Lab
Seattle, WA
|
76.3 | — | — | — | 454 programs |
| 18 |
CG
Cytiva (Mfg Services)
Marlborough, MA · Uppsala, SE
|
74.0 | — | — | — | 0 programs |
| 19 |
LZ
Lonza Biologics
Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
|
73.0 | 95.7 | 1 insp · 0 GMP | Limited | 0 programs |
| 20 |
IO
Iovance Biotherapeutics (Mfg)
Philadelphia, PA
|
70.8 | — | — | — | 31 programs |
| 21 |
CT
CTMC
Houston, TX
|
63.0 | — | — | — | 0 programs |
| 22 |
GF
GeneFab
Alameda, CA and South San Francisco
|
61.5 | — | — | Available | 0 programs |
| 23 |
CL
Cellares
South San Francisco, CA
|
59.0 | — | — | Available | 0 programs |
| 24 |
MS
Made Scientific
Princeton, NJ
|
59.0 | — | — | — | 0 programs |
| 25 |
MX
MaxCyte
Gaithersburg, MD
|
59.0 | — | — | — | 0 programs |
| 26 |
C3
C3i Center
Houston, TX
|
59.0 | — | — | — | 0 programs |
| 27 |
AS
Artis BioSolutions
Lake Nona, FL
|
59.0 | — | — | — | 0 programs |
| 28 |
AP
Applied StemCell
Milpitas, CA
|
59.0 | — | — | — | 0 programs |
| 29 |
PO
Poseida Therapeutics (CDMO)
San Diego, CA
|
58.7 | — | — | — | 6 programs |
| 30 |
TG
ThermoGenesis
Rancho Cordova, CA
|
57.8 | — | — | — | 1 programs |
| 31 |
KC
Kincell Bio
Research Triangle Park, NC
|
56.5 | — | — | — | 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.
FDA jurisdiction — how the ranking scores US-based CDMOs
The Signal Score's Quality Compliance pillar (35% of the composite) is dominated by FDA inspection data for US-based CDMOs: Establishment Inspection Report classifications (NAI, VAI, OAI), Form 483 observation counts, and Warning Letter history. For a CDMO whose primary facility footprint is US, this pillar carries direct weight — an inspection on the site slated for a sponsor's program applies without translation. For CDMOs with mixed US + international facility footprint, the ranking reflects the composite regulatory posture; sponsors evaluating for a specific program should verify inspection history on the exact US site under consideration via that CDMO's profile page.
Which US CDMOs also cover EU and UK regulatory geographies?
Many top-tier US-based CDMOs maintain EU (EMA) and UK (MHRA) GMP certification for facilities used to supply EU and UK trials or commercial markets. The Signal Score's Quality Compliance pillar includes EMA + MHRA certificate density as a component — a US-headquartered CDMO with dense EU/UK certificates typically ranks higher on this pillar than a US-only competitor. Sponsors running dual-jurisdiction programs should cross-check the individual CDMO profile pages for specific certificate coverage; the Europe region ranking surfaces CDMOs that also appear in the European jurisdiction ranking, indicating multi-region regulatory posture.
How CDMO Signal identifies US manufacturing presence
Region attribution is derived from each CDMO's declared facility locations in our directory. A CDMO's facility list is validated against corporate filings, press releases, and — where public — the FDA facility registration (FEI number lookups). Region matching is done at the country level: a US state name or two-letter abbreviation in the facility list places the CDMO in the US region. CDMOs with US + international sites appear in every applicable region ranking, which reflects operational reality — such a CDMO is a legitimate candidate for programs in any of those jurisdictions.
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 13 Cell Therapy CDMOs with FDA inspection records and 82 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