Lonza
Basel, Switzerland
1 confirmed programs
· 1 sponsors
· Last scored 2026-04-29
73.8
Signal Score
✓ FDA Inspections (2)
✓ Clinical Trials (1)
○ SEC Filings
✓ Press (20)
✓ EMA GMP (3)
✓ MHRA GMP (5)
Quick Facts: Lonza
- Signal Score
- 73.8/100 (as of 2026-04-29)
- Quality Compliance
- 82.6/100
- Headquarters
- Basel, Switzerland
- Modalities
- AAV, Lentiviral, Cell Therapy, mRNA
- Active Programs
- 1 confirmed from ClinicalTrials.gov across 1 sponsors
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Lonza
Largest CGT CDMO globally by program count.
Signal Score & Pillar Breakdown
Quality Compliance
82.6
FDA Inspections2 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-09-29)
EMA GMP Certificates3 on record
MHRA GMP Certificates5 on record
Operations
50.0
1 active programs across 1 sponsors
Modalities: Lentiviral, AAV, Cell Therapy, mRNA
Source: ClinicalTrials.gov
1 active programs across 1 sponsors · Modalities: Lentiviral, AAV, Cell Therapy, mRNA
Programs
1
Sponsors1
ModalitiesAAV, Lentiviral, Cell Therapy, mRNA
1 active programs across 1 sponsors
Modalities: Lentiviral, AAV, Cell Therapy, mRNA
Source: ClinicalTrials.gov facility matching
Source: ClinicalTrials.gov · Retrieved May 27, 2026
Financial Stability
75.0
Publicly traded — financial transparency
M&A activity detected (3 articles)
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Publicly traded — financial transparency
M&A activity detected (3 articles)
Capacity
87.0
Multi-site operations (4 manufacturing sites)
Broad modality coverage (4 modalities)
Facility expansion news detected
Strong partnership activity (5 articles)
Regulatory milestones (17 articles)
Sites: Houston, TX, Walkersville, MD, Geleen, Netherlands, Portsmouth, NH
Source: SEC EDGAR, press monitoring, company profiles
4 manufacturing sites
Recent Press20 articles
Multi-site operations (4 manufacturing sites)
Broad modality coverage (4 modalities)
Facility expansion news detected
Strong partnership activity (5 articles)
Regulatory milestones (17 articles)
Lonza FDA Inspection History
2025-09
2025-08
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-29 | Vacaville, California | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2025-08-22 | Tampa, Florida | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved May 27, 2026
Lonza FDA 483 Findings 9 observations · 2025-08-22 → 2025-08-22 ?
By subsystem
By severity
- 5 — Critical: 1
- 3 — Moderate: 2
- 2 — Minor: 6
- Repeat observations: 0
Most severe findings
-
Computer control of master formula records
"Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel."
-
In-process materials characteristics testing
"In-process materials are not tested for identity, strength, quality and purity and approved or rejected by the quality control unit during the production process and after storage for long periods."
-
Scientifically sound laboratory controls
"Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity."
Lonza EMA GMP Compliance 3 certificates
2025-04
2025-02
2022-12
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| NCF-01/2025-GAL | Lonza Biologics Porrino S.L. | Spain | 2025-04-07 | COMPLIANT |
| NL/H 25/2055564A | Lonza Netherlands B.V. | Netherlands | 2025-02-20 | COMPLIANT |
| NL/H 22/2044124B | Lonza Netherlands B.V. | Netherlands | 2022-12-01 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved May 27, 2026
Lonza MHRA GMP Compliance 5 certificates
2025-12
2025-12
2016-02
2014-04
2010-06
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK MIA(IMP) 18606 Insp GMP/IMP 18606/11099-0019[I] | LONZA BIOLOGICS PLC | SLOUGH SL1 4DX | 2025-12-08 | COMPLIANT |
| UK MIA 18606 Insp GMP/IMP 18606/11099-0019[H] | LONZA BIOLOGICS PLC | SLOUGH SL1 4DX | 2025-12-08 | COMPLIANT |
| UK GMP 43108 Insp GMP 43108/9937079-0003[H] | LONZA BIOLOGICS TUAS PTE LIMITED | SG-637377 | 2016-02-22 | COMPLIANT |
| UK GMP 18606 Insp GMP 18606/835874-0005[H] | LONZA BIOLOGICS PLC | WOKINGHAM RG41 5TU | 2014-04-29 | COMPLIANT |
| UK GMP 18601 Insp GMP 18601/11093-0002[H] | LONZA BIOLOGICS | 03801 | 2010-06-14 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved May 27, 2026
Clinical Activity 1 studies
Source: ClinicalTrials.gov · Retrieved May 27, 2026
Recent News 20 articles
STARLIMS Completes Acquisition Of MODA® Platform From Lonza To Expand End To End Digital Manufacturing And Quality Capabilities - BioPharma APAC
STARLIMS Completes Acquisition Of MODA® Platform From Lonza To Expand End To End Digital Manufacturing And Quality Capabilities BioPharma APAC
Lonza Group Stock (CH0013841017): Dividend Ex-Date Set for May 13, 2026 - AD HOC NEWS
Lonza Group Stock (CH0013841017): Dividend Ex-Date Set for May 13, 2026 AD HOC NEWS
CDMO Injectable Drugs Market Set to Boom Rapidly by 2033 |Lonza Group, Thermo Fisher Scientific, Catalent, Inc. - openPR.com
CDMO Injectable Drugs Market Set to Boom Rapidly by 2033 |Lonza Group, Thermo Fisher Scientific, Catalent, Inc. openPR.com
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing strong enough to unlock new - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing strong enough to unlock new AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing now the real growth engine? - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing now the real growth engine? AD HOC NEWS
Lonza Group AG stock (CH0013841017): Why biocontracting stability now outweighs cell therapy uncerta - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Why biocontracting stability now outweighs cell therapy uncerta AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract model resilient enough for new growth - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract model resilient enough for new growth AD HOC NEWS
Lonza Group AG stock (CH0013841017): Why biopharma contract manufacturing now matters more for U.S. - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Why biopharma contract manufacturing now matters more for U.S. AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing strong enough to unlock new - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing strong enough to unlock new AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract expertise strong enough to unlock new - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract expertise strong enough to unlock new AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract demand strong enough to drive sustained g - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract demand strong enough to drive sustained g AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract focus strong enough to unlock new ups - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract focus strong enough to unlock new ups AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract edge strong enough to unlock new upsi - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract edge strong enough to unlock new upsi AD HOC NEWS
Lonza Group AG stock (CH0013841017): Why biopharma contract manufacturing now matters more for U.S. - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Why biopharma contract manufacturing now matters more for U.S. AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract strength enough for steady U.S. inves - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract strength enough for steady U.S. inves AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract dominance strong enough to unlock new - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is its biopharma contract dominance strong enough to unlock new AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract demand strong enough to drive sustained u - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract demand strong enough to drive sustained u AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing strong enough to unlock new - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing strong enough to unlock new AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing strong enough to unlock new - AD HOC NEWS
Lonza Group AG stock (CH0013841017): Is biopharma contract manufacturing strong enough to unlock new AD HOC NEWS
Lonza AG Opens a New Bioprocessing Laboratory in Singapore - ChemAnalyst
Lonza AG Opens a New Bioprocessing Laboratory in Singapore ChemAnalyst
Frequently Asked Questions About Lonza
How many FDA inspections does Lonza have on record?
CDMO Signal tracks 2 FDA inspections for Lonza, sourced from the FDA inspection database. See the full inspection history above.
Has Lonza received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Lonza.
Does Lonza hold EMA or MHRA GMP certificates?
CDMO Signal tracks 3 EMA and 5 MHRA GMP certificates for Lonza.
How many clinical programs is Lonza linked to?
Lonza is associated with 1 clinical trial in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Lonza's CDMO Signal Score?
Lonza has a Signal Score of 74/100, based on quality, operations, financial stability, and capacity data.
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