AAV / Gene Therapy CDMOs with Clean FDA Inspection History

← All AAV CDMOs Best Clean FDA History Commercial Scale

Region: USA Europe Asia

CDMOs tracked

Fully scored

With FDA records

FDA inspections

157

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), 21 VAI (voluntary action), 0 OAI (official action). Leading inspection & GMP sites: UNITED KINGDOM (42), Denmark (35), United States (33), Germany (13), Ireland (11).

Last updated 2026-08-22. Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.

#	CDMO	Signal Score	Quality	FDA · GMP	Capacity	Programs
1	TF Thermo Fisher Scientific Plainville, MA · Alachua, FL · Cambridge, MA	83.1	97.9	6 insp · 10 GMP	Available	2 programs
2	AG AGC Biologics Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP	80.6	99.9	2 insp · 23 GMP	Available	2 programs
3	TK Takeda Boston, MA · Zurich, CH	80.5	99.3	4 insp · 18 GMP	—	100 programs
4	Lonza Basel, Switzerland	78.2	95.1	2 insp · 8 GMP	—	1 programs
5	OX Oxford Biomedica Oxford, United Kingdom	77.1	100.0	0 insp · 13 GMP	Available	7 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	91.7	98.7	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	AJ Ajinomoto Bio-Pharma Services San Diego, CA · Osaka, JP	85.6	100.0	0 insp · 1 GMP	—	0 programs
12	LB Lotte Biologics Incheon, KR · Syracuse, NY	83.7	100.0	1 insp · 0 GMP	—	0 programs
13	WB2 WuXi Biologics Shanghai, CN · Wuxi, CN	83.7	100.0	0 insp · 4 GMP	—	0 programs
14	KB KBI Biopharma Durham, NC · Boulder, CO	83.5	100.0	1 insp · 1 GMP	Limited	0 programs
15	FD FUJIFILM Diosynth Biotechnologies Research Triangle, NC · Holly Springs, NC · Hillerod, DK	83.5	100.0	0 insp · 23 GMP	Expanding	0 programs
16	BR BioReliance (Merck) Glasgow, UK · Rockville, MD	81.0	98.8	4 insp · 8 GMP	—	0 programs
17	NW Northway Biotech Vilnius, LT; Waltham (MA), USA	80.8	100.0	0 insp · 8 GMP	Available	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	PG ProBioGen Berlin, DE	78.9	100.0	0 insp · 2 GMP	—	0 programs
21	XP eXmoor Pharma Bristol, United Kingdom	78.7	100.0	0 insp · 1 GMP	—	0 programs
22	AA Ascend Advanced Therapies London, United Kingdom	78.1	100.0	0 insp · 1 GMP	—	0 programs
23	NG NecstGen Leiden, NL	78.1	100.0	0 insp · 1 GMP	—	0 programs
24	ET Exothera Jumet, BE	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	AD Advent Bioservices London, United Kingdom	78.1	100.0	0 insp · 2 GMP	—	0 programs
27	BV Biovian Turku, Finland	78.0	99.7	1 insp · 4 GMP	—	0 programs
28	AG2 August Bioservices San Carlos, CA	77.4	98.5	1 insp · 0 GMP	—	0 programs
29	VG Viralgen Vector Core San Sebastián, Spain	76.8	100.0	0 insp · 4 GMP	Available	0 programs
30	LZ Lonza Biologics Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH	72.8	95.1	1 insp · 0 GMP	Limited	0 programs
31	GZ Genezen Indianapolis, IN · Lexington, MA	70.7	84.1	3 insp · 0 GMP	Available	0 programs

How we score CDMOs →

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 Thermo Fisher Scientific, AGC Biologics, Takeda. 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 14 AAV / Gene Therapy CDMOs with FDA inspection records and 157 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.

Related modalities

Lentiviral Vector CDMOs Gene Editing CDMOs Plasmid DNA CDMOs

Other Modalities

CAR-T Lentiviral Cell Therapy mRNA/LNP Plasmid DNA Biologics Oligo/ASO Adenoviral Gene Editing Exosome Recombinant Proteins ADC Gene Therapy Cell & Gene Therapy