Gene Therapy CDMOs with Clean FDA Inspection History

← All Gene Therapy CDMOs Best Clean FDA History Commercial Scale

Region: USA Europe Asia

CDMOs tracked

Fully scored

With FDA records

FDA inspections

219

EMA/MHRA GMP certs

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: 23 NAI (no action), 29 VAI (voluntary action), 2 OAI (official action). Leading inspection & GMP sites: Austria (51), United States (46), UNITED KINGDOM (44), Denmark (35), Germany (15).

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	Expanding	0 programs
18	BR BioReliance (Merck) Glasgow, UK · Rockville, MD	81.0	98.8	4 insp · 8 GMP	—	0 programs
19	NW Northway Biotech Vilnius, LT; Waltham (MA), USA	80.8	100.0	0 insp · 8 GMP	Available	0 programs
20	OB OmniaBio Hamilton, ON	79.5	100.0	0 insp · 2 GMP	—	0 programs
21	SK SK pharmteco Dublin, Ireland. Rancho Cordova, CA. King of Prussia, PA. Houston, TX. Korea. France.	79.5	100.0	—	Available	0 programs
22	PG ProBioGen Berlin, DE	78.9	100.0	0 insp · 2 GMP	—	0 programs
23	XP eXmoor Pharma Bristol, United Kingdom	78.7	100.0	0 insp · 1 GMP	—	0 programs
24	AA Ascend Advanced Therapies London, United Kingdom	78.1	100.0	0 insp · 1 GMP	—	0 programs
25	NG NecstGen Leiden, NL	78.1	100.0	0 insp · 1 GMP	—	0 programs
26	ET Exothera Jumet, BE	78.1	100.0	0 insp · 4 GMP	—	0 programs
27	CE Celonic Basel, Switzerland	78.1	100.0	0 insp · 1 GMP	—	0 programs
28	AD Advent Bioservices London, United Kingdom	78.1	100.0	0 insp · 2 GMP	—	0 programs
29	BV Biovian Turku, Finland	78.0	99.7	1 insp · 4 GMP	—	0 programs
30	AG2 August Bioservices San Carlos, CA	77.4	98.5	1 insp · 0 GMP	—	0 programs
31	VG Viralgen Vector Core San Sebastián, Spain	76.8	100.0	0 insp · 4 GMP	Available	0 programs
32	LZ Lonza Biologics Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH	72.8	95.1	1 insp · 0 GMP	Limited	0 programs
33	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 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.

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 16 Gene Therapy CDMOs with FDA inspection records and 219 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

AAV / Gene Therapy CDMOs Lentiviral Vector CDMOs Adenoviral Vector CDMOs Cell Therapy CDMOs

Other Modalities

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