AAV / Gene Therapy CDMOs with Clean FDA Inspection History
· updated as new inspection, certificate, and trial data enters the platform
32
CDMOs tracked
32
Fully scored
15
With FDA records
39
FDA inspections
159
EMA/MHRA GMP certs
Adeno-associated virus (AAV) is the dominant delivery platform for in vivo gene therapy, from rare-disease programs to larger systemic indications. Rising demand has pushed CDMOs to scale suspension processes and tighten full/empty capsid analytics.
Selecting an AAV CDMO hinges on serotype experience, suspension vs adherent platform, full/empty capsid separation, and a proven regulatory record. The rankings below score each manufacturer on FDA inspections, GMP certification, clinical activity, and capacity.
FDA inspection outcomes across these CDMOs: 17 NAI (no action), 22 VAI (voluntary action), 0 OAI (official action). Leading inspection & GMP sites: UNITED KINGDOM (42), Denmark (35), United States (34), Germany (15), Ireland (11).
Last updated 2026-10-06. Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.
| # | CDMO | Signal Score | Quality | FDA · GMP | Capacity | Programs |
|---|---|---|---|---|---|---|
| 1 |
TK
Takeda
Boston, MA · Zurich, CH
|
81.9 | 99.6 | 4 insp · 18 GMP | — | 100 programs |
| 2 |
TF
Thermo Fisher Scientific
Plainville, MA · Alachua, FL · Cambridge, MA
|
81.0 | 100.0 | 6 insp · 10 GMP | Available | 2 programs |
| 3 |
AG
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
|
78.6 | 100.0 | 2 insp · 23 GMP | Available | 2 programs |
| 4 |
OX
Oxford Biomedica
Oxford, United Kingdom
|
76.2 | 100.0 | 0 insp · 13 GMP | Available | 7 programs |
| 5 |
Lonza
Basel, Switzerland
|
76.0 | 95.7 | 2 insp · 8 GMP | — | 1 programs |
| 6 |
CI
Cincinnati Children's Vector Production Facility
Cincinnati, OH
|
75.2 | 100.0 | 1 insp · 0 GMP | — | 1 programs |
| 7 |
RT
ReiThera
Rome, IT
|
71.1 | 100.0 | 0 insp · 4 GMP | — | 1 programs |
| 8 |
CR
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
|
90.9 | 98.3 | 8 insp · 11 GMP | Limited | 0 programs |
| 9 |
RP
ReciBioPharm
Keele, UK · Sodertalje, SE
|
88.0 | 100.0 | 0 insp · 3 GMP | — | 0 programs |
| 10 |
PB
Pharmaron Biologics
San Diego, CA · Shaoxing, China, Liverpool, UK, Ningbo China
|
86.9 | 100.0 | 3 insp · 0 GMP | Available | 0 programs |
| 11 |
FD
FUJIFILM Diosynth Biotechnologies
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
|
84.8 | 100.0 | 0 insp · 23 GMP | 0 programs | |
| 12 |
KB
KBI Biopharma
Durham, NC · Boulder, CO
|
84.4 | 99.1 | 1 insp · 1 GMP | Limited | 0 programs |
| 13 |
AJ
Ajinomoto Bio-Pharma Services
San Diego, CA · Osaka, JP
|
83.5 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 14 |
WB2
WuXi Biologics
Shanghai, CN · Wuxi, CN
|
82.9 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 15 |
LB
Lotte Biologics
Incheon, KR · Syracuse, NY
|
81.6 | 100.0 | 1 insp · 0 GMP | — | 0 programs |
| 16 |
NW
Northway Biotech
Vilnius, LT; Waltham (MA), USA
|
80.8 | 100.0 | 0 insp · 8 GMP | Available | 0 programs |
| 17 |
BR
BioReliance (Merck)
Glasgow, UK · Rockville, MD
|
80.2 | 97.1 | 4 insp · 8 GMP | — | 0 programs |
| 18 |
OB
OmniaBio
Hamilton, ON
|
79.5 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 19 |
SK
SK pharmteco
Dublin, Ireland. Rancho Cordova, CA. King of Prussia, PA. Houston, TX. Korea. France.
|
79.5 | 100.0 | — | Available | 0 programs |
| 20 |
UM
MassBiologics
Boston, MA
|
79.0 | 97.2 | 1 insp · 0 GMP | — | 0 programs |
| 21 |
AA
Ascend Advanced Therapies
London, United Kingdom
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 22 |
NG
NecstGen
Leiden, NL
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 23 |
ET
Exothera
Jumet, BE
|
78.1 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 24 |
PG
ProBioGen
Berlin, DE
|
78.1 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 25 |
CE
Celonic
Basel, Switzerland
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 26 |
XP
eXmoor Pharma
Bristol, United Kingdom
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 27 |
AD
Advent Bioservices
London, United Kingdom
|
78.1 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 28 |
BV
Biovian
Turku, Finland
|
78.0 | 99.8 | 1 insp · 4 GMP | — | 0 programs |
| 29 |
AG2
August Bioservices
San Carlos, CA
|
77.5 | 98.7 | 1 insp · 0 GMP | — | 0 programs |
| 30 |
VG
Viralgen Vector Core
San Sebastián, Spain
|
76.8 | 100.0 | 0 insp · 4 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 |
GZ
Genezen
Indianapolis, IN · Lexington, MA
|
71.5 | 85.8 | 3 insp · 0 GMP | Available | 0 programs |
What to evaluate in a AAV / Gene Therapy CDMO
Platform & scale
Suspension processes scale better than adherent (HEK293) for commercial volumes. Confirm the CDMO's largest validated bioreactor scale and serotype track record.
Capsid quality
Full/empty capsid ratio and aggregate control drive potency and safety. Ask about AUC, anion-exchange separation, and the analytics package for capsid characterization.
Regulatory readiness
For programs heading to BLA, a strong FDA inspection history and EMA/MHRA GMP coverage matter — both are shown above and on each profile.
Capacity & timelines
AAV manufacturing slots can be constrained. Weigh the capacity signal and clinical-program load before committing.
AAV / Gene Therapy CDMOs — Frequently Asked Questions
Who are the top AAV / Gene Therapy CDMOs?
By CDMO Signal's independent Signal Score, the top-ranked AAV / Gene Therapy CDMOs include Takeda, Thermo Fisher Scientific, AGC Biologics. See the full ranked table above — scored on FDA, clinical, financial, and capacity data.
How many AAV / Gene Therapy CDMOs have FDA inspection records?
CDMO Signal tracks 15 AAV / Gene Therapy CDMOs with FDA inspection records and 159 EMA/MHRA GMP certificates across the group.
What should I look for in an AAV CDMO?
Look for serotype experience, a scalable suspension platform, strong full/empty capsid analytics, and a clean FDA and EMA/MHRA record. Match validated bioreactor scale to your dose and indication.
What's the difference between AAV and lentiviral CDMOs?
AAV is non-integrating and produced at higher volumes for in vivo gene therapy. Lentivirus integrates into the genome, is made under BSL-2 with RCL testing, and is used mainly for ex vivo cell engineering like CAR-T.
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