Cell Therapy CDMOs with Clean FDA Inspection History

← All Cell Therapy CDMOs Best Clean FDA History Commercial Scale

CDMOs tracked

Fully scored

With FDA records

FDA inspections

136

EMA/MHRA GMP certs

Warning letters

Cell therapy CDMOs manufacture living products — CAR-T, TCR, NK, and stem-cell therapies — where the process is the product. Autologous programs add patient-scheduling and chain-of-identity demands that allogeneic, batch-based programs avoid.

The right cell therapy CDMO depends on autologous vs allogeneic experience, vector sourcing, closed-system processing, and cold-chain logistics. The rankings below score each CDMO on FDA inspections, GMP certification, clinical activity, and capacity.

FDA inspection outcomes across these CDMOs: 25 NAI (no action), 26 VAI (voluntary action), 1 OAI (official action). Leading inspection & GMP sites: United States (42), Germany (29), UNITED KINGDOM (22), Denmark (18), Ireland (16).

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	COH City of Hope (T Cell Manufacturing) Duarte, CA	83.8	96.8	3 insp · 0 GMP	—	207 programs
4	WB2 WuXi Biologics Shanghai, CN · Wuxi, CN	83.7	100.0	0 insp · 4 GMP	—	0 programs
5	MN Minaris Advanced Therapies Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP	83.5	100.0	1 insp · 6 GMP	Limited	0 programs
6	MK Merck KGaA / MilliporeSigma (CDMO) Darmstadt, DE · St. Louis, MO	81.8	98.6	2 insp · 2 GMP	—	22 programs
7	SC SCTbio Prague, Czech Republic	81.6	100.0	0 insp · 5 GMP	—	0 programs
8	EF Eurofins CDMO Planegg, DE · San Diego, CA	81.6	100.0	4 insp · 0 GMP	—	0 programs
9	AG AGC Biologics Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP	80.6	99.9	1 insp · 23 GMP	Available	2 programs
10	TK Takeda Boston, MA · Zurich, CH	80.5	99.3	3 insp · 18 GMP	—	100 programs
11	CF CELLforCURE (SEQENS) Les Ulis, FR	80.3	100.0	0 insp · 4 GMP	—	0 programs
12	RC RoslinCT Edinburgh, UK · Hopkinton, MA	80.2	98.8	1 insp · 1 GMP	Available	0 programs
13	SG Syngene International Bangalore, India	79.7	95.9	2 insp · 0 GMP	—	0 programs
14	OB OmniaBio Hamilton, ON	79.5	100.0	0 insp · 2 GMP	—	0 programs
15	GS GenScript ProBio Piscataway, NJ · Nanjing, CN	79.5	100.0	—	Constrained	0 programs
16	BY Bayer (Cell Therapy Mfg) Berkeley, CA	79.2	86.9	8 insp · 16 GMP	—	125 programs
17	CS Cedars-Sinai Biomanufacturing Los Angeles, CA	78.9	100.0	1 insp · 0 GMP	—	31 programs
18	XP eXmoor Pharma Bristol, UK	78.7	100.0	0 insp · 1 GMP	—	0 programs
19	Lonza Basel, Switzerland	78.2	95.1	2 insp · 8 GMP	—	1 programs
20	NG NecstGen Leiden, NL	78.1	100.0	0 insp · 1 GMP	—	0 programs
21	OR Ori Biotech London, UK	78.1	100.0	0 insp · 1 GMP	—	0 programs
22	CC CCRM Toronto, ON	78.1	100.0	5 insp · 0 GMP	—	0 programs
23	CE Celonic Basel, Switzerland	78.1	100.0	0 insp · 1 GMP	—	0 programs
24	GP Green Phoenix Labs San Diego, CA	78.1	100.0	0 insp · 1 GMP	—	0 programs
25	BC Biocon Biologics Bangalore, India	77.1	96.1	4 insp · 1 GMP	—	0 programs
26	SY Symbiosis Pharmaceutical Services Stirling, UK	76.8	100.0	1 insp · 9 GMP	—	0 programs
27	IP Intas Pharmaceuticals Ahmedabad, IN	76.8	100.0	0 insp · 5 GMP	—	0 programs
28	CY Cell-Easy Toulouse, FR	76.8	100.0	0 insp · 2 GMP	—	0 programs
29	CN Cellin Technologies Luxembourg, LU	76.8	100.0	0 insp · 1 GMP	—	0 programs
30	HH HiTech Health London, UK	76.8	100.0	0 insp · 9 GMP	—	0 programs
31	MB Miltenyi Biotec Bergisch Gladbach, Germany	74.6	100.0	0 insp · 2 GMP	—	8 programs
32	NR National Resilience San Diego, CA · Boston, MA · RTP, NC · Philadelphia, PA	73.4	97.7	1 insp · 0 GMP	Available	9 programs
33	LZ Lonza Biologics Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH	72.8	95.1	1 insp · 0 GMP	Limited	0 programs

How we score CDMOs →

What to evaluate in a Cell Therapy CDMO

Autologous vs allogeneic

Autologous needs per-patient scheduling, chain-of-identity, and short turnaround; allogeneic needs scalable batch processing and a master cell bank strategy. Pick a CDMO proven in your model.

Vector & raw materials

Most cell therapies need a viral vector. Confirm whether the CDMO makes vector in-house or coordinates an external supplier, and how that affects timelines.

Closed-system & cleanrooms

Closed, automated processing reduces contamination risk and labor. Ask about cleanroom grade, automation platforms, and parallel-suite capacity.

Cold chain & logistics

Cryopreservation and chain-of-custody are critical for living cells. Evaluate the CDMO's cold-chain and apheresis-to-infusion logistics.

Cell Therapy CDMOs — Frequently Asked Questions

Who are the top Cell Therapy CDMOs?

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

How many Cell Therapy CDMOs have FDA inspection records?

CDMO Signal tracks 18 Cell Therapy CDMOs with FDA inspection records and 136 EMA/MHRA GMP certificates across the group.

What should I look for in a cell therapy CDMO?

Match the CDMO to your model: autologous needs chain-of-identity and fast turnaround; allogeneic needs scalable batch processing. Confirm vector sourcing, closed-system processing, cold-chain logistics, and a clean FDA and EMA/MHRA record.

Do cell therapy CDMOs make their own viral vectors?

Some do in-house; others coordinate an external vector supplier. In-house vector can shorten timelines and simplify supply, but a strong external partner is common. Check each profile's modality coverage above.

Related modalities

Lentiviral Vector CDMOs CAR-T CDMOs Gene Editing CDMOs

Other Modalities

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