Best Cell & Gene Therapy CDMOs in Europe
59
CDMOs tracked
45
Fully scored
15
With FDA records
60
FDA inspections
270
EMA/MHRA GMP certs
2
Warning letters
For European-manufactured cell & gene therapy programs, Novartis, Merck KGaA / MilliporeSigma (CDMO), and AGC Biologics lead CDMO Signal's ranking of cell & gene therapy CDMOs with confirmed European manufacturing sites. Filtered from the global directory of 106 scored cell & gene therapy CDMOs to 8 with European facility presence. EU and UK manufacturing carry specific regulatory considerations for sponsors: EMA and MHRA GMP certification — which contribute directly to the Signal Score's Quality Compliance pillar — are typically required for material supplied to EU/UK trials or commercial markets, and Qualified Person (QP) release is a distinct process step that doesn't apply to US-only manufacturing. Rankings update as new inspection and certificate data enters the platform. Full methodology at cdmosignal.com/methodology.
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: 22 NAI (no action), 34 VAI (voluntary action), 4 OAI (official action). Leading inspection & GMP sites: UNITED KINGDOM (60), Austria (51), United States (48), Denmark (35), Germany (25).
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 |
MK
Merck KGaA / MilliporeSigma (CDMO)
Darmstadt, DE · St. Louis, MO
|
81.8 | 98.6 | 2 insp · 2 GMP | — | 22 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 |
MB
Miltenyi Biotec
Bergisch Gladbach, Germany
|
74.6 | 100.0 | 0 insp · 2 GMP | — | 8 programs |
| 8 |
RT
ReiThera
Rome, IT
|
71.1 | 100.0 | 0 insp · 4 GMP | — | 1 programs |
| 9 |
CR
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
|
91.7 | 98.7 | 8 insp · 11 GMP | Limited | 0 programs |
| 10 |
RP
ReciBioPharm
Keele, UK · Sodertalje, SE
|
88.0 | 100.0 | 0 insp · 3 GMP | — | 0 programs |
| 11 |
FD
FUJIFILM Diosynth Biotechnologies
Research Triangle, NC · Holly Springs, NC · Hillerod, DK
|
83.5 | 100.0 | 0 insp · 23 GMP | 0 programs | |
| 12 |
MN
Minaris Advanced Therapies
Philadelphia, PA · Allendale, NJ · Munich, DE · Yokohama, JP
|
83.5 | 100.0 | 1 insp · 6 GMP | Limited | 0 programs |
| 13 |
SC
SCTbio
Prague, Czech Republic
|
81.6 | 100.0 | 0 insp · 5 GMP | — | 0 programs |
| 14 |
EF
Eurofins CDMO
Planegg, DE · San Diego, CA
|
81.6 | 100.0 | 5 insp · 0 GMP | — | 0 programs |
| 15 |
BR
BioReliance (Merck)
Glasgow, UK · Rockville, MD
|
81.0 | 98.8 | 4 insp · 8 GMP | — | 0 programs |
| 16 |
CF
CELLforCURE (SEQENS)
Les Ulis, FR
|
80.3 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 17 |
RC
RoslinCT
Edinburgh, UK · Hopkinton, MA
|
80.2 | 98.8 | 1 insp · 1 GMP | Available | 0 programs |
| 18 |
SK
SK pharmteco
Dublin, Ireland. Rancho Cordova, CA. King of Prussia, PA. Houston, TX. Korea. France.
|
79.5 | 100.0 | — | Available | 0 programs |
| 19 |
PG
ProBioGen
Berlin, DE
|
78.9 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 20 |
XP
eXmoor Pharma
Bristol, United Kingdom
|
78.7 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 21 |
AA
Ascend Advanced Therapies
London, United Kingdom
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 22 |
NG
NecstGen
Leiden, NL
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 23 |
ET
Exothera
Jumet, BE
|
78.1 | 100.0 | 0 insp · 4 GMP | — | 0 programs |
| 24 |
OR
Ori Biotech
London, UK
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 25 |
CE
Celonic
Basel, Switzerland
|
78.1 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 26 |
AD
Advent Bioservices
London, United Kingdom
|
78.1 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 27 |
BV
Biovian
Turku, Finland
|
78.0 | 99.7 | 1 insp · 4 GMP | — | 0 programs |
| 28 |
VG
Viralgen Vector Core
San Sebastián, Spain
|
76.8 | 100.0 | 0 insp · 4 GMP | Available | 0 programs |
| 29 |
SY
Symbiosis Pharmaceutical Services
Stirling, United Kingdom
|
76.8 | 100.0 | 1 insp · 9 GMP | — | 0 programs |
| 30 |
CY
Cell-Easy
Toulouse, FR
|
76.8 | 100.0 | 0 insp · 2 GMP | — | 0 programs |
| 31 |
CN
Cellin Technologies
Luxembourg, LU
|
76.8 | 100.0 | 0 insp · 1 GMP | — | 0 programs |
| 32 |
HH
HiTech Health
London, United Kingdom
|
76.8 | 100.0 | 0 insp · 9 GMP | — | 0 programs |
| 33 |
Catalent
Bagsværd, Denmark (operating under Novo Holdings; legacy US operations headquartered in Somerset, NJ)
|
76.5 | 79.3 | 12 insp · 35 GMP | — | 0 programs |
| 34 |
CA
Catalent (Novo Holdings)
Harmans, MD · Gosselies, BE
|
75.1 | 79.3 | 1 insp · 0 GMP | Available | 0 programs |
| 35 |
CG
Cytiva (Mfg Services)
Marlborough, MA · Uppsala, SE
|
74.0 | — | — | — | 0 programs |
| 36 |
LZ
Lonza Biologics
Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
|
72.8 | 95.1 | 1 insp · 0 GMP | Limited | 0 programs |
| 37 |
RA
Recipharm Advanced Bio
Stockholm, Sweden (US operations: Watertown, MA; EU/global ATMP division of Recipharm AB)
|
63.0 | — | — | — | 0 programs |
| 38 |
AB
Asklepios BioPharmaceutical (AskBio)
Research Triangle, NC · San Sebastian, ES
|
59.7 | — | — | — | 10 programs |
| 39 |
CP
Cell and Gene Therapy Catapult
Stevenage, United Kingdom
|
59.0 | — | — | — | 0 programs |
| 40 |
EX
Excellos
La Rochelle, France
|
59.0 | — | — | — | 0 programs |
| 41 |
CZ
Cellex Cell Professionals
Cologne, Germany
|
59.0 | — | — | — | 0 programs |
| 42 |
AM
Anemocyte
Gerenzano, IT
|
59.0 | — | — | — | 0 programs |
| 43 |
DINAMIQS
Schlieren (Zurich), Switzerland
|
59.0 | — | — | Available | 0 programs |
| 44 |
CV
CEVEC Pharmaceuticals
Cologne, DE
|
56.5 | — | — | — | 0 programs |
| 45 |
CX
CellGenix
Freiburg, DE
|
56.5 | — | — | — | 0 programs |
| — |
3P Biopharmaceuticals (now 3PBIOVIAN)
Pamplona-Noáin, Spain
|
Profiled | — | — | — | 0 programs |
| — |
VIVEbiotech
San Sebastián, Spain
|
Profiled | — | — | — | 0 programs |
| — |
Roche / Genentech (Internal Manufacturing & CustomBiotech)
Basel, Switzerland
|
Profiled | — | — | — | 0 programs |
| — |
Coriolis Pharma
Martinsried (Munich), Germany
|
Profiled | — | — | — | 0 programs |
| — |
Spur Therapeutics
London, United Kingdom
|
Profiled | — | — | — | 0 programs |
| — |
Eppendorf BioBLU
Hamburg, Germany
|
Profiled | — | — | — | 0 programs |
| — |
Cellistic
Mont-Saint-Guibert, Belgium
|
Profiled | — | — | — | 0 programs |
| — |
NegotiumBio LLC & GmbH
Basel, Switzerland (GmbH) / US entity (LLC)
|
Profiled | — | — | — | 0 programs |
| — |
IDT Biologika GmbH
Dessau-Roßlau, Germany
|
Profiled | — | — | — | 0 programs |
| — |
Pharmaron Biologics (Liverpool)
Liverpool, United Kingdom
|
Profiled | — | — | — | 0 programs |
| — |
Fresenius Kabi
Bad Homburg, Germany
|
Profiled | — | — | — | 0 programs |
| — |
Genzyme (Sanofi)
Cambridge, MA (division of Sanofi, HQ: Paris, France)
|
Profiled | — | — | — | 0 programs |
| — |
Sanofi (Genzyme / Sanofi Manufacturing)
Paris, France
|
Profiled | — | — | — | 0 programs |
| — |
Novasep
Lyon, France
|
Profiled | — | — | — | 0 programs |
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.
EMA and MHRA regulatory considerations for European-manufactured programs
European manufacturing for biopharma programs typically requires EMA-recognized GMP certification (via the EudraGMDP database) for EU material and MHRA GMP certification for UK material — post-Brexit, these are separate credentials even for CDMOs operating in both. The Signal Score's Quality Compliance pillar weighs EMA + MHRA GMP certificate density directly, so European CDMOs with dense certification typically rank higher on this pillar. Sponsors should verify certificate coverage for the specific manufacturing activity (drug substance vs drug product, dosage form) at the specific facility being considered — GMP certificates are activity-scoped, not blanket.
QP release requirements and how they affect CDMO selection
Every batch of medicinal product supplied to the EU market must be released by a Qualified Person (QP) — a specific regulatory role with statutory responsibility. This adds a process step (and typically a specific QP-service arrangement) that US-only manufacturing does not require. CDMOs with European operations either have in-house QPs (typical for larger diversified players) or coordinate with external QP services. For sponsors running EU trials or supplying EU commercial markets, this is a non-negotiable requirement to plan for. Individual CDMO profile pages capture facility-level detail; QP arrangements specifically are usually confirmed at RFP stage rather than published.
Which European CDMOs also cover FDA (US) regulatory geography?
European CDMOs with US FDA inspection history — indicating US regulatory posture — are candidates for sponsors running programs in both jurisdictions. The Signal Score's Quality Compliance pillar includes FDA inspection classifications, so a European CDMO with a strong FDA record typically ranks higher on that pillar than a European-only competitor. Cross-check with the US region ranking — CDMOs appearing in both rankings have demonstrated regulatory posture across both jurisdictions, which reduces tech-transfer risk for global programs.
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 Novartis, Merck KGaA / MilliporeSigma (CDMO), AGC Biologics. 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 15 Cell & Gene Therapy CDMOs with FDA inspection records and 270 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.
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