Best Cell & Gene Therapy CDMOs in United States
· updated as new inspection, certificate, and trial data enters the platform
56
CDMOs tracked
56
Fully scored
23
With FDA records
65
FDA inspections
133
EMA/MHRA GMP certs
For US-manufactured cell & gene therapy programs, Bristol Myers Squibb (CGT Mfg), City of Hope (T Cell Manufacturing), and Takeda lead CDMO Signal's ranking of cell & gene therapy CDMOs with confirmed US facilities. Filtered from the global directory of 105 scored cell & gene therapy CDMOs to 10 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 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: 32 NAI (no action), 32 VAI (voluntary action), 1 OAI (official action). Leading inspection & GMP sites: United States (58), Denmark (35), Germany (27), UNITED KINGDOM (24), Ireland (10).
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 |
TF
Thermo Fisher Scientific
Plainville, MA · Alachua, FL · Cambridge, MA
|
81.0 | 100.0 | 6 insp · 10 GMP | Available | 2 programs |
| 6 |
BY
Bayer (Cell Therapy Mfg)
Berkeley, CA
|
80.4 | 90.1 | 8 insp · 18 GMP | — | 126 programs |
| 7 |
CS
Cedars-Sinai Biomanufacturing
Los Angeles, CA
|
79.8 | 100.0 | 1 insp · 0 GMP | — | 34 programs |
| 8 |
AG
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
|
78.6 | 100.0 | 2 insp · 23 GMP | Available | 2 programs |
| 9 |
CI
Cincinnati Children's Vector Production Facility
Cincinnati, OH
|
75.2 | 100.0 | 1 insp · 0 GMP | — | 1 programs |
| 10 |
NR
National Resilience
San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA
|
74.5 | 98.0 | 1 insp · 0 GMP | Available | 9 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 |
PB
Pharmaron Biologics
San Diego, CA · Shaoxing, China, Liverpool, UK, Ningbo China
|
86.9 | 100.0 | 3 insp · 0 GMP | Available | 0 programs |
| 13 |
FD
FUJIFILM Diosynth Biotechnologies
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
|
84.8 | 100.0 | 0 insp · 23 GMP | 0 programs | |
| 14 |
KB
KBI Biopharma
Durham, NC · Boulder, CO
|
84.4 | 99.1 | 1 insp · 1 GMP | Limited | 0 programs |
| 15 |
AJ
Ajinomoto Bio-Pharma Services
San Diego, CA · Osaka, JP
|
83.5 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 16 |
MN
Minaris Advanced Therapies
Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
|
83.3 | 99.6 | 1 insp · 6 GMP | Limited | 0 programs |
| 17 |
LB
Lotte Biologics
Incheon, KR · Syracuse, NY
|
81.6 | 100.0 | 1 insp · 0 GMP | — | 0 programs |
| 18 |
EF
Eurofins CDMO
Planegg, DE · San Diego, CA
|
81.6 | 100.0 | 5 insp · 0 GMP | — | 0 programs |
| 19 |
DH
Danaher (CGT Portfolio)
Washington, DC
|
81.5 | — | — | — | 0 programs |
| 20 |
NW
Northway Biotech
Vilnius, LT; Waltham (MA), USA
|
80.8 | 100.0 | 0 insp · 8 GMP | Available | 0 programs |
| 21 |
RC
RoslinCT
Edinburgh, UK · Hopkinton, MA
|
80.3 | 99.0 | 1 insp · 1 GMP | Available | 0 programs |
| 22 |
BR
BioReliance (Merck)
Glasgow, UK · Rockville, MD
|
80.2 | 97.1 | 4 insp · 8 GMP | — | 0 programs |
| 23 |
GS
GenScript ProBio
Piscataway, NJ · Nanjing, CN
|
79.5 | 100.0 | — | Constrained | 0 programs |
| 24 |
UM
MassBiologics
Boston, MA
|
79.0 | 97.2 | 1 insp · 0 GMP | — | 0 programs |
| 25 |
BB
bluebird bio Manufacturing
Durham, NC
|
78.5 | — | — | — | 0 programs |
| 26 |
GP
Green Phoenix Labs
San Diego, CA
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 27 |
AG2
August Bioservices
San Carlos, CA
|
77.5 | 98.7 | 1 insp · 0 GMP | — | 0 programs |
| 28 |
FH
Fred Hutch Cell Therapy Lab
Seattle, WA
|
76.3 | — | — | — | 454 programs |
| 29 |
CG
Cytiva (Mfg Services)
Marlborough, MA · Uppsala, SE
|
74.0 | — | — | — | 0 programs |
| 30 |
CA
Catalent (Novo Holdings)
Harmans, MD · Gosselies, BE
|
73.1 | 74.9 | 1 insp · 0 GMP | Available | 0 programs |
| 31 |
LZ
Lonza Biologics
Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
|
73.0 | 95.7 | 1 insp · 0 GMP | Limited | 0 programs |
| 32 |
VE
Vigene Biosciences
Rockville, MD
|
72.5 | — | — | — | 0 programs |
| 33 |
GZ
Genezen
Indianapolis, IN · Lexington, MA
|
71.5 | 85.8 | 3 insp · 0 GMP | Available | 0 programs |
| 34 |
EM
Emergent BioSolutions (CGT)
Baltimore, MD
|
71.0 | — | — | — | 4 programs |
| 35 |
IO
Iovance Biotherapeutics (Mfg)
Philadelphia, PA
|
70.8 | — | — | — | 31 programs |
| 36 |
AN
Andelyn Biosciences
Columbus, OH
|
63.0 | — | — | Available | 0 programs |
| 37 |
CT
CTMC
Houston, TX
|
63.0 | — | — | — | 0 programs |
| 38 |
AB
Asklepios BioPharmaceutical (AskBio)
Research Triangle, NC · San Sebastian, ES
|
61.8 | — | — | — | 10 programs |
| 39 |
GF
GeneFab
Alameda, CA and South San Francisco
|
61.5 | — | — | Available | 0 programs |
| 40 |
FB
Forge Biologics
Columbus, OH
|
61.2 | — | — | 3 programs | |
| 41 |
MA
Matica Biotechnology
College Station, TX
|
59.0 | — | — | Available | 0 programs |
| 42 |
CL
Cellares
South San Francisco, CA
|
59.0 | — | — | Available | 0 programs |
| 43 |
VB
VintaBio
Cambridge, MA
|
59.0 | — | — | — | 0 programs |
| 44 |
MS
Made Scientific
Princeton, NJ
|
59.0 | — | — | — | 0 programs |
| 45 |
WB
Waisman Biomanufacturing
Madison, WI
|
59.0 | — | — | — | 0 programs |
| 46 |
EB
ElevateBio BaseCamp
Waltham, MA
|
59.0 | — | — | — | 0 programs |
| 47 |
MX
MaxCyte
Gaithersburg, MD
|
59.0 | — | — | — | 0 programs |
| 48 |
C3
C3i Center
Houston, TX
|
59.0 | — | — | — | 0 programs |
| 49 |
AS
Artis BioSolutions
Lake Nona, FL
|
59.0 | — | — | — | 0 programs |
| 50 |
VM
Vector BioMed
Cambridge, MA
|
59.0 | — | — | — | 0 programs |
| 51 |
AP
Applied StemCell
Milpitas, CA
|
59.0 | — | — | — | 0 programs |
| 52 |
Vantage Vector (Demo)
Gaithersburg, MD
|
59.0 | — | — | Available | 0 programs |
| 53 |
PO
Poseida Therapeutics (CDMO)
San Diego, CA
|
58.7 | — | — | — | 6 programs |
| 54 |
TG
ThermoGenesis
Rancho Cordova, CA
|
57.8 | — | — | — | 1 programs |
| 55 |
KC
Kincell Bio
Research Triangle Park, NC
|
56.5 | — | — | — | 0 programs |
| 56 |
UB
uBriGene Biosciences
Shanghai, CN · Boston, MA
|
56.5 | — | — | — | 0 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.
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 & 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), City of Hope (T Cell Manufacturing), Takeda. 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 23 Cell & Gene Therapy CDMOs with FDA inspection records and 133 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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