Gene Therapy CDMOs — Ranked by Signal Score · 2026
86
CDMOs tracked
61
Fully scored
19
With FDA records
68
FDA inspections
254
EMA/MHRA GMP certs
2
Warning letters
On CDMO Signal's composite Signal Score, Novartis, Thermo Fisher Scientific, and AGC Biologics lead the gene therapy CDMO rankings — an aggregation across AAV, lentiviral, and adenoviral vector manufacturers. The Signal Score is a 0–100 composite of four weighted pillars — Quality Compliance (35%), Operations (25%), Financial Stability (20%), and Capacity Intelligence (20%) — built from FDA inspection history, EMA/MHRA GMP certificates, ClinicalTrials.gov sponsor footprint, and monitored capacity signals. Vector platform is the first cut in any gene therapy CDMO shortlist: AAV programs weight suspension platform maturity and full/empty capsid analytics; lentiviral programs weight BSL-2 containment integrity and RCL testing; adenoviral programs weight yield and process comparability. See the dedicated AAV, lentiviral, and adenoviral pages for platform-filtered rankings. Full methodology at cdmosignal.com/methodology.
Gene therapy is delivered through viral vectors — AAV, lentiviral, and adenoviral being the three dominant platforms. AAV dominates in vivo systemic delivery (rare disease, ophthalmology, neurology); lentivirus is the workhorse for ex vivo cell engineering including CAR-T; adenoviral vectors remain relevant for vaccines and select gene therapy programs. Most gene therapy CDMOs specialize in one or two vector platforms, and platform experience is the first filter in any sponsor's shortlist.
The ranking below aggregates every CDMO tracked as a gene therapy manufacturer across these platforms. For platform-specific rankings, use the dedicated pages: <a href="/modality/aav">AAV CDMOs</a>, <a href="/modality/lentiviral">Lentiviral Vector CDMOs</a>, <a href="/modality/adenoviral">Adenoviral Vector CDMOs</a>. For sponsors evaluating end-to-end programs that combine vector manufacturing with downstream cell processing, the <a href="/modality/cell-and-gene-therapy">cell and gene therapy view</a> extends this list with cell therapy CDMOs.
FDA inspection outcomes across these CDMOs: 26 NAI (no action), 38 VAI (voluntary action), 4 OAI (official action). Leading inspection & GMP sites: United States (59), UNITED KINGDOM (52), Austria (51), Denmark (35), Germany (20).
Last updated 2026-08-22. Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.
| # | CDMO | Signal Score | Quality | FDA · GMP | Capacity | Programs |
|---|---|---|---|---|---|---|
| 1 |
Novartis
Basel, Switzerland
|
88.3 | 90.9 | 15 insp · 62 GMP | — | 135 programs |
| 2 |
TF
Thermo Fisher Scientific
Plainville, MA · Alachua, FL · Cambridge, MA
|
83.1 | 97.9 | 6 insp · 10 GMP | Available | 2 programs |
| 3 |
AG
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
|
80.6 | 99.9 | 2 insp · 23 GMP | Available | 2 programs |
| 4 |
TK
Takeda
Boston, MA · Zurich, CH
|
80.5 | 99.3 | 4 insp · 18 GMP | — | 100 programs |
| 5 |
Lonza
Basel, Switzerland
|
78.2 | 95.1 | 2 insp · 8 GMP | — | 1 programs |
| 6 |
OX
Oxford Biomedica
Oxford, United Kingdom
|
77.1 | 100.0 | 0 insp · 13 GMP | Available | 7 programs |
| 7 |
CI
Cincinnati Children's Vector Production Facility
Cincinnati, OH
|
75.2 | 100.0 | 1 insp · 0 GMP | — | 1 programs |
| 8 |
NR
National Resilience
San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA
|
73.4 | 97.7 | 1 insp · 0 GMP | Available | 9 programs |
| 9 |
RT
ReiThera
Rome, IT
|
71.1 | 100.0 | 0 insp · 4 GMP | — | 1 programs |
| 10 |
CR
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
|
91.7 | 98.7 | 8 insp · 11 GMP | Limited | 0 programs |
| 11 |
RP
ReciBioPharm
Keele, UK · Sodertalje, SE
|
88.0 | 100.0 | 0 insp · 3 GMP | — | 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 |
AJ
Ajinomoto Bio-Pharma Services
San Diego, CA · Osaka, JP
|
85.6 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 14 |
LB
Lotte Biologics
Incheon, KR · Syracuse, NY
|
83.7 | 100.0 | 1 insp · 0 GMP | — | 0 programs |
| 15 |
WB2
WuXi Biologics
Shanghai, CN · Wuxi, CN
|
83.7 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 16 |
KB
KBI Biopharma
Durham, NC · Boulder, CO
|
83.5 | 100.0 | 1 insp · 1 GMP | Limited | 0 programs |
| 17 |
FD
FUJIFILM Diosynth Biotechnologies
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
|
83.5 | 100.0 | 0 insp · 23 GMP | 0 programs | |
| 18 |
DH
Danaher (CGT Portfolio)
Washington, DC
|
81.5 | — | — | — | 0 programs |
| 19 |
BR
BioReliance (Merck)
Glasgow, UK · Rockville, MD
|
81.0 | 98.8 | 4 insp · 8 GMP | — | 0 programs |
| 20 |
NW
Northway Biotech
Vilnius, LT; Waltham (MA), USA
|
80.8 | 100.0 | 0 insp · 8 GMP | Available | 0 programs |
| 21 |
OB
OmniaBio
Hamilton, ON
|
79.5 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 22 |
SK
SK pharmteco
Dublin, Ireland. Rancho Cordova, CA. King of Prussia, PA. Houston, TX. Korea. France.
|
79.5 | 100.0 | — | Available | 0 programs |
| 23 |
PG
ProBioGen
Berlin, DE
|
78.9 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 24 |
XP
eXmoor Pharma
Bristol, United Kingdom
|
78.7 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 25 |
BB
bluebird bio Manufacturing
Durham, NC
|
78.5 | — | — | — | 0 programs |
| 26 |
AA
Ascend Advanced Therapies
London, United Kingdom
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 27 |
NG
NecstGen
Leiden, NL
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 28 |
ET
Exothera
Jumet, BE
|
78.1 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 29 |
CE
Celonic
Basel, Switzerland
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 30 |
AD
Advent Bioservices
London, United Kingdom
|
78.1 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 31 |
BV
Biovian
Turku, Finland
|
78.0 | 99.7 | 1 insp · 4 GMP | — | 0 programs |
| 32 |
AG2
August Bioservices
San Carlos, CA
|
77.4 | 98.5 | 1 insp · 0 GMP | — | 0 programs |
| 33 |
VG
Viralgen Vector Core
San Sebastián, Spain
|
76.8 | 100.0 | 0 insp · 4 GMP | Available | 0 programs |
| 34 |
Catalent
Bagsværd, Denmark (operating under Novo Holdings; legacy US operations headquartered in Somerset, NJ)
|
76.5 | 79.3 | 12 insp · 35 GMP | — | 0 programs |
| 35 |
CA
Catalent (Novo Holdings)
Harmans, MD · Gosselies, BE
|
75.1 | 79.3 | 1 insp · 0 GMP | Available | 0 programs |
| 36 |
CG
Cytiva (Mfg Services)
Marlborough, MA · Uppsala, SE
|
74.0 | — | — | — | 0 programs |
| 37 |
LZ
Lonza Biologics
Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
|
72.8 | 95.1 | 1 insp · 0 GMP | Limited | 0 programs |
| 38 |
VE
Vigene Biosciences
Rockville, MD
|
72.5 | — | — | — | 0 programs |
| 39 |
EM
Emergent BioSolutions (CGT)
Baltimore, MD
|
71.0 | — | — | — | 4 programs |
| 40 |
GZ
Genezen
Indianapolis, IN · Lexington, MA
|
70.7 | 84.1 | 3 insp · 0 GMP | Available | 0 programs |
| 41 |
IU
Indiana University Vector Production Facility
Indianapolis, IN
|
66.2 | — | — | — | 49 programs |
| 42 |
AN
Andelyn Biosciences
Columbus, OH
|
63.0 | — | — | Available | 0 programs |
| 43 |
UM
MassBiologics
Boston, MA
|
63.0 | — | 1 insp · 0 GMP | — | 0 programs |
| 44 |
RA
Recipharm Advanced Bio
Stockholm, Sweden (US operations: Watertown, MA; EU/global ATMP division of Recipharm AB)
|
63.0 | — | — | — | 0 programs |
| 45 |
FB
Forge Biologics
Columbus, OH
|
62.7 | — | — | 3 programs | |
| 46 |
MS
Made Scientific
Princeton, NJ
|
61.5 | — | — | — | 0 programs |
| 47 |
GF
GeneFab
Alameda, CA and South San Francisco
|
61.5 | — | — | Available | 0 programs |
| 48 |
UB
uBriGene Biosciences
Shanghai, CN · Boston, MA
|
60.5 | — | — | — | 0 programs |
| 49 |
CoJourney Inc.
Horsham, PA (US HQ); Hangzhou, China (primary GMP manufacturing)
|
60.0 | — | — | Limited | 0 programs |
| 50 |
AB
Asklepios BioPharmaceutical (AskBio)
Research Triangle, NC · San Sebastian, ES
|
59.7 | — | — | — | 10 programs |
| 51 |
TR
Takara Bio
Kusatsu, Shiga Prefecture, Japan
|
59.5 | — | — | — | 8 programs |
| 52 |
MA
Matica Biotechnology
College Station, TX
|
59.0 | — | — | Available | 0 programs |
| 53 |
VB
VintaBio
Cambridge, MA
|
59.0 | — | — | — | 0 programs |
| 54 |
WB
Waisman Biomanufacturing
Madison, WI
|
59.0 | — | — | — | 0 programs |
| 55 |
EB
ElevateBio BaseCamp
Waltham, MA
|
59.0 | — | — | — | 0 programs |
| 56 |
CP
Cell and Gene Therapy Catapult
Stevenage, United Kingdom
|
59.0 | — | — | — | 0 programs |
| 57 |
VM
Vector BioMed
Cambridge, MA
|
59.0 | — | — | — | 0 programs |
| 58 |
AM
Anemocyte
Gerenzano, IT
|
59.0 | — | — | — | 0 programs |
| 59 |
HX
Helixmith
Seoul, KR
|
59.0 | — | — | — | 0 programs |
| 60 |
DINAMIQS
Schlieren (Zurich), Switzerland
|
59.0 | — | — | Available | 0 programs |
| 61 |
CV
CEVEC Pharmaceuticals
Cologne, DE
|
56.5 | — | — | — | 0 programs |
| — |
3P Biopharmaceuticals (now 3PBIOVIAN)
Pamplona-Noáin, Spain
|
Profiled | — | — | — | 0 programs |
| — |
VIVEbiotech
San Sebastián, Spain
|
Profiled | — | — | — | 0 programs |
| — |
Roche / Genentech (Internal Manufacturing & CustomBiotech)
Basel, Switzerland
|
Profiled | — | — | — | 0 programs |
| — |
Altruist Biologics
Suzhou, China
|
Profiled | — | — | Available | 0 programs |
| — |
Rose BioSolutions
Wilmington, MA
|
Profiled | — | — | — | 0 programs |
| — |
Orphan Therapeutics Accelerator (OTXL)
Cambridge, MA
|
Profiled | — | — | — | 0 programs |
| — |
Coriolis Pharma
Martinsried (Munich), Germany
|
Profiled | — | — | — | 0 programs |
| — |
Porton Advanced
Cranbury, NJ
|
Profiled | — | — | — | 0 programs |
| — |
Vantage Vector (Demo)
Gaithersburg, MD
|
Profiled | — | — | Available | 0 programs |
| — |
Advanced BioScience Laboratories, Inc. (ABL Inc.)
Rockville, MD
|
Profiled | — | — | — | 0 programs |
| — |
Spur Therapeutics
London, United Kingdom
|
Profiled | — | — | — | 0 programs |
| — |
Ultragenyx (UX111 — AAV, Sanfilippo Syndrome Type A)
Novato, CA
|
Profiled | — | — | — | 0 programs |
| — |
AAV Gene Therapy Programs (Industry-Wide)
N/A — Industry Pattern
|
Profiled | — | — | — | 0 programs |
| — |
Eppendorf BioBLU
Hamburg, Germany
|
Profiled | — | — | — | 0 programs |
| — |
AAV Gene Therapy — Purification-Driven Program Failures (Industry Pattern)
N/A — Industry-Wide Pattern
|
Profiled | — | — | — | 0 programs |
| — |
Landmark Bio
Watertown, MA
|
Profiled | — | — | — | 0 programs |
| — |
NegotiumBio LLC & GmbH
Basel, Switzerland (GmbH) / US entity (LLC)
|
Profiled | — | — | — | 0 programs |
| — |
IDT Biologika GmbH
Dessau-Roßlau, Germany
|
Profiled | — | — | — | 0 programs |
| — |
Pharmaron Biologics (Liverpool)
Liverpool, United Kingdom
|
Profiled | — | — | — | 0 programs |
| — |
Canton Biologics Co., Ltd.
Foshan (Shunde District), China
|
Profiled | — | — | — | 0 programs |
| — |
Canton Biologics
Guangzhou, China
|
Profiled | — | — | — | 0 programs |
| — |
Laurus Labs
Hyderabad, India
|
Profiled | — | — | — | 0 programs |
| — |
Genzyme (Sanofi)
Cambridge, MA (division of Sanofi, HQ: Paris, France)
|
Profiled | — | — | — | 0 programs |
| — |
Novasep
Lyon, France
|
Profiled | — | — | — | 0 programs |
| — |
CDMO Industry — Market Size & Growth (2026)
Global
|
Profiled | — | — | — | 0 programs |
What to evaluate in a Gene Therapy CDMO
Vector platform match
The first shortlist filter for any gene therapy program is vector platform. AAV for in vivo systemic; lentiviral for ex vivo cell engineering; adenoviral for vaccines and select high-expression programs. Filter by platform first, then compare within the platform.
Regulatory record on-platform
A CDMO with a strong FDA record on AAV manufacturing doesn't automatically de-risk lentiviral work — inspections are facility- and process-specific. Verify the inspection record on the exact platform and site your program will use.
Capacity match to phase
Early clinical AAV runs at 50-200L; commercial can reach 1000-2000L single-batch. Lentiviral commercial supply is a much narrower field. Confirm the CDMO's capacity headroom at your target phase before shortlisting.
Analytics maturity
Vector analytics — capsid ratio, titer, potency, RCL for lentivirus — drive lot release. A CDMO with qualified, established assays de-risks comparability and tech transfer.
Which vector platform does my gene therapy program need?
The three dominant platforms map to distinct program types. AAV is the workhorse for in vivo systemic delivery — rare disease, ophthalmology, neurology, and increasingly cardiac and musculoskeletal indications. It's non-integrating, made at large batch volumes, and dominates approved in vivo gene therapy. Lentiviral vectors are the primary platform for ex vivo cell engineering, including CAR-T and gene-modified HSCs, because they integrate stably into the host genome. Adenoviral vectors retain relevance for vaccines and select gene therapy programs where high transient expression is acceptable. Most CDMOs specialize in one or two platforms rather than all three — filter by platform on the AAV, lentiviral, or adenoviral pages for platform-specific shortlists.
How does CDMO Signal aggregate gene therapy CDMOs?
The gene therapy ranking is a union of CDMOs tagged with any viral-vector platform in our directory (AAV, lentiviral, adenoviral) plus any CDMO tagged directly with "gene therapy". Each CDMO appears once regardless of how many vector platforms they cover — a manufacturer with all three platforms shows up here at their composite Signal Score, and the individual platform pages break out platform-specific rankings. Signal Score is computed identically across all modalities; the aggregation doesn't inflate scores, it just widens the candidate set.
Which gene therapy CDMOs cover multiple vector platforms?
Multi-platform CDMOs — those covering AAV, lentiviral, and often adenoviral — reduce program risk for sponsors evaluating multiple candidates or platforms. Large diversified players like Lonza, Catalent, Thermo Fisher, and Charles River span multiple platforms; specialists like Forge Biologics (AAV-focused) and Andelyn Biosciences deliver depth in one or two. Multi-platform coverage is one buyer signal; regulatory record on the specific target platform is another — the individual profile pages show each CDMO's inspection history and GMP posture at the level of granularity procurement teams need.
How is gene therapy CDMO scoring different from generic biologics?
The Signal Score composition is identical across all modalities, but the underlying data signals mean different things by modality. For gene therapy CDMOs, the Quality pillar (35%) reflects BSL-2 containment history (lentiviral), full/empty capsid analytics posture (AAV), and comparability data across facilities — signals that matter less for generic biologics. The Operations pillar (25%) reflects ClinicalTrials.gov footprint specifically as vector supplier or gene therapy manufacturer, not sponsor-of-record. Sponsors comparing gene therapy CDMOs should read the Signal Score as a starting-point composite and use the individual profile pages for program-specific validation.
Gene Therapy CDMOs — Frequently Asked Questions
Who are the top Gene Therapy CDMOs?
By CDMO Signal's independent Signal Score, the top-ranked Gene Therapy CDMOs include Novartis, Thermo Fisher Scientific, AGC Biologics. See the full ranked table above — scored on FDA, clinical, financial, and capacity data.
How many Gene Therapy CDMOs have FDA inspection records?
CDMO Signal tracks 19 Gene Therapy CDMOs with FDA inspection records and 254 EMA/MHRA GMP certificates across the group.
What should I look for in a gene therapy CDMO?
Match the vector platform to your program first (AAV / lentiviral / adenoviral). Then verify the CDMO's on-platform inspection record, capacity at your target phase, analytics maturity for that vector type, and a clean FDA and EMA/MHRA record. The individual platform pages have platform-specific detail.
How many gene therapy CDMOs does CDMO Signal track?
63 CDMOs are tracked as gene therapy manufacturers — the union of AAV, lentiviral, adenoviral, and generally-tagged gene therapy CDMOs. Each is scored independently on the standard four-pillar Signal Score composite.
Related modalities