Commercial-Scale CAR-T CDMOs

← All CAR-T CDMOs Best Clean FDA History Commercial Scale

CDMOs tracked

Fully scored

With FDA records

FDA inspections

111

EMA/MHRA GMP certs

CAR-T CDMOs manufacture engineered T-cell products, combining viral-vector transduction, T-cell activation and expansion, and rapid release testing — usually as autologous, per-patient batches on tight vein-to-vein timelines.

Choosing a CAR-T CDMO depends on autologous vs allogeneic experience, in-house vs sourced vector, closed-system processing, and chain-of-identity logistics, alongside a clean regulatory record. The rankings below score each CDMO on FDA inspections, GMP certification, clinical activity, and capacity.

FDA inspection outcomes across these CDMOs: 14 NAI (no action), 16 VAI (voluntary action), 2 OAI (official action). Leading inspection & GMP sites: Austria (33), United States (29), Denmark (18), Germany (12), France (8).

Last updated 2026-06-24. Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.

#	CDMO	Signal Score	Quality	FDA · GMP	Capacity	Programs
1	CR Charles River Laboratories Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD	91.7	98.7	7 insp · 11 GMP	Limited	0 programs
2	BMS Bristol Myers Squibb (CGT Mfg) Bothell, WA · Warren, NJ	90.8	97.0	5 insp · 2 GMP	—	576 programs
3	Novartis Basel, Switzerland	88.3	90.9	14 insp · 50 GMP	—	134 programs
4	COH City of Hope (T Cell Manufacturing) Duarte, CA	83.8	96.8	3 insp · 0 GMP	—	207 programs
5	WB2 WuXi Biologics Shanghai, CN · Wuxi, CN	83.7	100.0	0 insp · 4 GMP	—	0 programs
6	MN Minaris Advanced Therapies Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP	83.5	100.0	1 insp · 6 GMP	Limited	0 programs
7	SC SCTbio Prague, Czech Republic	81.6	100.0	0 insp · 5 GMP	—	0 programs
8	AG AGC Biologics Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP	80.6	99.9	1 insp · 23 GMP	Available	2 programs
9	CF CELLforCURE (SEQENS) Les Ulis, FR	80.3	100.0	0 insp · 4 GMP	—	0 programs
10	RC RoslinCT Edinburgh, UK · Hopkinton, MA	80.2	98.8	1 insp · 1 GMP	Available	0 programs
11	OB OmniaBio Hamilton, ON	79.5	100.0	0 insp · 2 GMP	—	0 programs
12	GS GenScript ProBio Piscataway, NJ · Nanjing, CN	79.5	100.0	—	Constrained	0 programs
13	NV Novartis Contract Manufacturing Morris Plains, NJ · Stein, CH	79.1	90.9	—	Constrained	282 programs
14	OR Ori Biotech London, UK	78.1	100.0	0 insp · 1 GMP	—	0 programs
15	FH Fred Hutch Cell Therapy Lab Seattle, WA	76.4	—	—	—	450 programs
16	MB Miltenyi Biotec Bergisch Gladbach, Germany	74.6	100.0	0 insp · 2 GMP	—	8 programs

How we score CDMOs →

What to evaluate in a CAR-T CDMO

Vector supply

CAR-T needs a lentiviral or retroviral vector. Confirm whether the CDMO produces vector in-house or coordinates a supplier, and how that affects timelines and cost.

Autologous logistics & turnaround

Autologous CAR-T lives or dies on vein-to-vein time and chain-of-identity. Evaluate scheduling, apheresis handling, and cryo-logistics.

Closed, scalable processing

Closed and automated platforms reduce contamination risk and support parallel patient slots. Ask about cleanroom grade and concurrent-batch capacity.

Regulatory track record

Cross-check FDA 483 history and EMA/MHRA GMP coverage — both shown above and on each profile.

CAR-T CDMOs — Frequently Asked Questions

Who are the top CAR-T CDMOs?

By CDMO Signal's independent Signal Score, the top-ranked CAR-T CDMOs include Charles River Laboratories, Bristol Myers Squibb (CGT Mfg), Novartis. See the full ranked table above — scored on FDA, clinical, financial, and capacity data.

How many CAR-T CDMOs have FDA inspection records?

CDMO Signal tracks 7 CAR-T CDMOs with FDA inspection records and 111 EMA/MHRA GMP certificates across the group.

What should I look for in a CAR-T CDMO?

Confirm vector supply (in-house or coordinated), autologous logistics and vein-to-vein turnaround, closed-system scalable processing for parallel patients, and a clean FDA and EMA/MHRA record.

Do CAR-T CDMOs make their own viral vectors?

Some produce lentiviral or retroviral vector in-house; others coordinate an external vector CDMO. In-house vector can shorten timelines and de-risk supply. Check each profile's modality coverage above.

Related modalities

Cell Therapy CDMOs Lentiviral Vector CDMOs Gene Editing CDMOs

Other Modalities

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