Cell & Gene Therapy CDMOs with Clean FDA Inspection History

← All Cell & Gene Therapy CDMOs Best Clean FDA History Commercial Scale

Region: USA Europe Asia

CDMOs tracked

Fully scored

With FDA records

FDA inspections

288

EMA/MHRA GMP certs

Warning letters

Cell and gene therapy manufacturing spans two adjacent product classes: living cell products (CAR-T, TCR, NK, stem cell therapies) and the viral vectors used to genetically modify them (AAV, lentiviral, adenoviral). The two are tightly coupled in ex vivo cell engineering — a lentiviral vector CDMO supplies the vector that a cell therapy CDMO uses to modify patient T cells for CAR-T. Sponsors running integrated programs benefit from CDMOs covering both, and the ranking below aggregates that combined view.

For platform-specific rankings, use the dedicated pages: <a href="/modality/cell-therapy">Cell Therapy CDMOs</a>, <a href="/modality/aav">AAV CDMOs</a>, <a href="/modality/lentiviral">Lentiviral Vector CDMOs</a>, <a href="/modality/adenoviral">Adenoviral Vector CDMOs</a>, <a href="/modality/gene-therapy">Gene Therapy CDMOs</a> (vectors only, no cell processing).

FDA inspection outcomes across these CDMOs: 45 NAI (no action), 45 VAI (voluntary action), 3 OAI (official action). Leading inspection & GMP sites: United States (76), UNITED KINGDOM (60), Austria (51), Germany (35), Denmark (35).

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

#	CDMO	Signal Score	Quality	FDA · GMP	Capacity	Programs
1	BMS Bristol Myers Squibb (CGT Mfg) Bothell, WA · Warren, NJ	90.8	97.0	6 insp · 2 GMP	—	583 programs
2	Novartis Basel, Switzerland	88.3	90.9	15 insp · 62 GMP	—	135 programs
3	COH City of Hope (T Cell Manufacturing) Duarte, CA	83.8	96.8	3 insp · 0 GMP	—	211 programs
4	TF Thermo Fisher Scientific Plainville, MA · Alachua, FL · Cambridge, MA	83.1	97.9	6 insp · 10 GMP	Available	2 programs
5	MK Merck KGaA / MilliporeSigma (CDMO) Darmstadt, DE · St. Louis, MO	81.8	98.6	2 insp · 2 GMP	—	22 programs
6	AG AGC Biologics Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP	80.6	99.9	2 insp · 23 GMP	Available	2 programs
7	TK Takeda Boston, MA · Zurich, CH	80.5	99.3	4 insp · 18 GMP	—	100 programs
8	BY Bayer (Cell Therapy Mfg) Berkeley, CA	79.2	86.9	8 insp · 17 GMP	—	126 programs
9	CS Cedars-Sinai Biomanufacturing Los Angeles, CA	78.9	100.0	1 insp · 0 GMP	—	34 programs
10	Lonza Basel, Switzerland	78.2	95.1	2 insp · 8 GMP	—	1 programs
11	OX Oxford Biomedica Oxford, United Kingdom	77.1	100.0	0 insp · 13 GMP	Available	7 programs
12	CI Cincinnati Children's Vector Production Facility Cincinnati, OH	75.2	100.0	1 insp · 0 GMP	—	1 programs
13	MB Miltenyi Biotec Bergisch Gladbach, Germany	74.6	100.0	0 insp · 2 GMP	—	8 programs
14	NR National Resilience San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA	73.4	97.7	1 insp · 0 GMP	Available	9 programs
15	RT ReiThera Rome, IT	71.1	100.0	0 insp · 4 GMP	—	1 programs
16	CR Charles River Laboratories Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD	91.7	98.7	8 insp · 11 GMP	Limited	0 programs
17	RP ReciBioPharm Keele, UK · Sodertalje, SE	88.0	100.0	0 insp · 3 GMP	—	0 programs
18	PB Pharmaron Biologics San Diego, CA · Shaoxing, China, Liverpool, UK, Ningbo China	86.9	100.0	3 insp · 0 GMP	Available	0 programs
19	AJ Ajinomoto Bio-Pharma Services San Diego, CA · Osaka, JP	85.6	100.0	0 insp · 1 GMP	—	0 programs
20	LB Lotte Biologics Incheon, KR · Syracuse, NY	83.7	100.0	1 insp · 0 GMP	—	0 programs
21	WB2 WuXi Biologics Shanghai, CN · Wuxi, CN	83.7	100.0	0 insp · 4 GMP	—	0 programs
22	KB KBI Biopharma Durham, NC · Boulder, CO	83.5	100.0	1 insp · 1 GMP	Limited	0 programs
23	FD FUJIFILM Diosynth Biotechnologies Research Triangle, NC · Holly Springs, NC · Hillerod, DK	83.5	100.0	0 insp · 23 GMP	Expanding	0 programs
24	MN Minaris Advanced Therapies Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP	83.5	100.0	1 insp · 6 GMP	Limited	0 programs
25	SC SCTbio Prague, Czech Republic	81.6	100.0	0 insp · 5 GMP	—	0 programs
26	EF Eurofins CDMO Planegg, DE · San Diego, CA	81.6	100.0	5 insp · 0 GMP	—	0 programs
27	BR BioReliance (Merck) Glasgow, UK · Rockville, MD	81.0	98.8	4 insp · 8 GMP	—	0 programs
28	NW Northway Biotech Vilnius, LT; Waltham (MA), USA	80.8	100.0	0 insp · 8 GMP	Available	0 programs
29	CF CELLforCURE (SEQENS) Les Ulis, FR	80.3	100.0	0 insp · 4 GMP	—	0 programs
30	RC RoslinCT Edinburgh, UK · Hopkinton, MA	80.2	98.8	1 insp · 1 GMP	Available	0 programs
31	SG Syngene International Bengaluru, India	79.7	95.9	2 insp · 0 GMP	—	0 programs
32	OB OmniaBio Hamilton, ON	79.5	100.0	0 insp · 2 GMP	—	0 programs
33	GS GenScript ProBio Piscataway, NJ · Nanjing, CN	79.5	100.0	—	Constrained	0 programs
34	SK SK pharmteco Dublin, Ireland. Rancho Cordova, CA. King of Prussia, PA. Houston, TX. Korea. France.	79.5	100.0	—	Available	0 programs
35	PG ProBioGen Berlin, DE	78.9	100.0	0 insp · 2 GMP	—	0 programs
36	XP eXmoor Pharma Bristol, United Kingdom	78.7	100.0	0 insp · 1 GMP	—	0 programs
37	AA Ascend Advanced Therapies London, United Kingdom	78.1	100.0	0 insp · 1 GMP	—	0 programs
38	NG NecstGen Leiden, NL	78.1	100.0	0 insp · 1 GMP	—	0 programs
39	ET Exothera Jumet, BE	78.1	100.0	0 insp · 4 GMP	—	0 programs
40	OR Ori Biotech London, UK	78.1	100.0	0 insp · 1 GMP	—	0 programs
41	CC CCRM Toronto, ON, Canada	78.1	100.0	5 insp · 0 GMP	—	0 programs
42	CE Celonic Basel, Switzerland	78.1	100.0	0 insp · 1 GMP	—	0 programs
43	AD Advent Bioservices London, United Kingdom	78.1	100.0	0 insp · 2 GMP	—	0 programs
44	GP Green Phoenix Labs San Diego, CA	78.1	100.0	0 insp · 1 GMP	—	0 programs
45	BV Biovian Turku, Finland	78.0	99.7	1 insp · 4 GMP	—	0 programs
46	AG2 August Bioservices San Carlos, CA	77.4	98.5	1 insp · 0 GMP	—	0 programs
47	BC Biocon Biologics Bangalore, India	77.1	96.1	4 insp · 2 GMP	—	0 programs
48	VG Viralgen Vector Core San Sebastián, Spain	76.8	100.0	0 insp · 4 GMP	Available	0 programs
49	SY Symbiosis Pharmaceutical Services Stirling, United Kingdom	76.8	100.0	1 insp · 9 GMP	—	0 programs
50	IP Intas Pharmaceuticals Ahmedabad, India	76.8	100.0	0 insp · 5 GMP	—	0 programs
51	CY Cell-Easy Toulouse, FR	76.8	100.0	0 insp · 2 GMP	—	0 programs
52	CN Cellin Technologies Luxembourg, LU	76.8	100.0	0 insp · 1 GMP	—	0 programs
53	HH HiTech Health London, United Kingdom	76.8	100.0	0 insp · 9 GMP	—	0 programs
54	LZ Lonza Biologics Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH	72.8	95.1	1 insp · 0 GMP	Limited	0 programs
55	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 Cell & Gene Therapy CDMO

Integrated vs point-solution CDMO

Ex vivo cell therapy programs benefit from CDMOs handling both vector and cell processing under one roof. Point-solution CDMOs specialize deeper but add tech-transfer complexity.

Regulatory record by process class

Cell therapy and viral vector inspections are separately scoped. Verify the CDMO's inspection record on the specific process class your program will use.

Chain-of-identity + cold chain

Autologous cell therapy demands per-patient scheduling, batch-of-one tracking, and cold-chain logistics that CDMOs vary meaningfully on. Confirm the CDMO's chain-of-identity software and cryopreservation posture.

Commercial track record

For late-stage programs, CDMOs with commercial-approved cell or gene therapy products on file carry demonstrable posture that ranking algorithms only partially capture.

Cell & Gene Therapy CDMOs — Frequently Asked Questions

Who are the top Cell & Gene Therapy CDMOs?

By CDMO Signal's independent Signal Score, the top-ranked Cell & Gene Therapy CDMOs include Bristol Myers Squibb (CGT Mfg), Novartis, City of Hope (T Cell Manufacturing). See the full ranked table above — scored on FDA, clinical, financial, and capacity data.

How many Cell & Gene Therapy CDMOs have FDA inspection records?

CDMO Signal tracks 28 Cell & Gene Therapy CDMOs with FDA inspection records and 288 EMA/MHRA GMP certificates across the group.

What should I look for in a cell and gene therapy CDMO?

Start with process class match — cell therapy vs vector vs both. For ex vivo programs benefit from integrated CDMOs. Verify inspection record on the specific process class, confirm capacity match to your patient volume, and prioritize CDMOs with commercial-scale posture for late-stage work.

How many cell and gene therapy CDMOs does CDMO Signal track?

109 CDMOs are tracked as cell or gene therapy manufacturers — the union of cell therapy, AAV, lentiviral, adenoviral, and gene therapy-tagged CDMOs. This is the broadest advanced-therapy candidate list on our platform.

Related modalities

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

Other Modalities

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