Best Gene Therapy CDMOs in United States

← All Gene Therapy CDMOs Best Clean FDA History Commercial Scale

Region: USA Europe Asia

CDMOs tracked

Fully scored

With FDA records

FDA inspections

103

EMA/MHRA GMP certs

For US-manufactured gene therapy programs, Thermo Fisher Scientific, AGC Biologics, and Takeda lead CDMO Signal's ranking of gene therapy CDMOs with confirmed US facilities. Filtered from the global directory of 61 scored gene therapy CDMOs to 5 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.

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: 17 NAI (no action), 21 VAI (voluntary action), 0 OAI (official action). Leading inspection & GMP sites: Denmark (35), United States (34), UNITED KINGDOM (23), Austria (9), Ireland (9).

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	CI Cincinnati Children's Vector Production Facility Cincinnati, OH	75.2	100.0	1 insp · 0 GMP	—	1 programs
5	NR National Resilience San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA	73.4	97.7	1 insp · 0 GMP	Available	9 programs
6	CR Charles River Laboratories Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD	91.7	98.7	8 insp · 11 GMP	Limited	0 programs
7	PB Pharmaron Biologics San Diego, CA · Shaoxing, China, Liverpool, UK, Ningbo China	86.9	100.0	3 insp · 0 GMP	Available	0 programs
8	AJ Ajinomoto Bio-Pharma Services San Diego, CA · Osaka, JP	85.6	100.0	0 insp · 1 GMP	—	0 programs
9	LB Lotte Biologics Incheon, KR · Syracuse, NY	83.7	100.0	1 insp · 0 GMP	—	0 programs
10	KB KBI Biopharma Durham, NC · Boulder, CO	83.5	100.0	1 insp · 1 GMP	Limited	0 programs
11	FD FUJIFILM Diosynth Biotechnologies Research Triangle, NC · Holly Springs, NC · Hillerod, DK	83.5	100.0	0 insp · 23 GMP	Expanding	0 programs
12	DH Danaher (CGT Portfolio) Washington, DC	81.5	—	—	—	0 programs
13	BR BioReliance (Merck) Glasgow, UK · Rockville, MD	81.0	98.8	4 insp · 8 GMP	—	0 programs
14	NW Northway Biotech Vilnius, LT; Waltham (MA), USA	80.8	100.0	0 insp · 8 GMP	Available	0 programs
15	BB bluebird bio Manufacturing Durham, NC	78.5	—	—	—	0 programs
16	AG2 August Bioservices San Carlos, CA	77.4	98.5	1 insp · 0 GMP	—	0 programs
17	CA Catalent (Novo Holdings) Harmans, MD · Gosselies, BE	75.1	79.3	1 insp · 0 GMP	Available	0 programs
18	CG Cytiva (Mfg Services) Marlborough, MA · Uppsala, SE	74.0	—	—	—	0 programs
19	LZ Lonza Biologics Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH	72.8	95.1	1 insp · 0 GMP	Limited	0 programs
20	VE Vigene Biosciences Rockville, MD	72.5	—	—	—	0 programs
21	EM Emergent BioSolutions (CGT) Baltimore, MD	71.0	—	—	—	4 programs
22	GZ Genezen Indianapolis, IN · Lexington, MA	70.7	84.1	3 insp · 0 GMP	Available	0 programs
23	AN Andelyn Biosciences Columbus, OH	63.0	—	—	Available	0 programs
24	UM MassBiologics Boston, MA	63.0	—	1 insp · 0 GMP	—	0 programs
25	FB Forge Biologics Columbus, OH	62.7	—	—	Expanding	3 programs
26	MS Made Scientific Princeton, NJ	61.5	—	—	—	0 programs
27	GF GeneFab Alameda, CA and South San Francisco	61.5	—	—	Available	0 programs
28	UB uBriGene Biosciences Shanghai, CN · Boston, MA	60.5	—	—	—	0 programs
29	AB Asklepios BioPharmaceutical (AskBio) Research Triangle, NC · San Sebastian, ES	59.7	—	—	—	10 programs
30	MA Matica Biotechnology College Station, TX	59.0	—	—	Available	0 programs
31	VB VintaBio Cambridge, MA	59.0	—	—	—	0 programs
32	WB Waisman Biomanufacturing Madison, WI	59.0	—	—	—	0 programs
33	EB ElevateBio BaseCamp Waltham, MA	59.0	—	—	—	0 programs
34	VM Vector BioMed Cambridge, MA	59.0	—	—	—	0 programs
—	Rose BioSolutions Wilmington, MA	Profiled	—	—	—	0 programs
—	Orphan Therapeutics Accelerator (OTXL) Cambridge, MA	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
—	Ultragenyx (UX111 — AAV, Sanfilippo Syndrome Type A) Novato, CA	Profiled	—	—	—	0 programs
—	Landmark Bio Watertown, MA	Profiled	—	—	—	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.

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.

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 Thermo Fisher Scientific, AGC Biologics, Takeda. 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 15 Gene Therapy CDMOs with FDA inspection records and 103 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