Lonza Biologics
Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
1 confirmed programs
· 1 sponsors
· Last scored 2026-04-29
68.6
Signal Score
✓ FDA Inspections (3)
✓ Clinical Trials (1)
○ SEC Filings
✓ Press (20)
✓ EMA GMP (3)
✓ MHRA GMP (5)
Quick Facts: Lonza Biologics
- Signal Score
- 68.6/100 (as of 2026-04-29)
- Quality Compliance
- 83.2/100
- Headquarters
- Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
- Modalities
- AAV, Lentiviral, Cell Therapy, mRNA, Monoclonal Antibody, Recombinant Protein
- 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 Biologics
Pure-play CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
83.2
FDA Inspections3 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2026-02-06)
EMA GMP Certificates3 on record
MHRA GMP Certificates5 on record
Operations
50.0
1 active programs across 1 sponsors
Modalities: Cell Therapy, AAV, Recombinant Protein, Lentiviral, Monoclonal Antibody, mRNA
Source: ClinicalTrials.gov
1 active programs across 1 sponsors · Modalities: Cell Therapy, AAV, Recombinant Protein, Lentiviral, Monoclonal Antibody, mRNA
Programs
1
Sponsors1
ModalitiesAAV, Lentiviral, Cell Therapy, mRNA, Monoclonal Antibody, Recombinant Protein
1 active programs across 1 sponsors
Modalities: Cell Therapy, AAV, Recombinant Protein, Lentiviral, Monoclonal Antibody, mRNA
Source: ClinicalTrials.gov facility matching
Source: ClinicalTrials.gov · Retrieved Jul 04, 2026
Financial Stability
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity
75.0
Multi-site operations (4 manufacturing sites)
Broad modality coverage (6 modalities)
Sites: Houston, TX, Portsmouth, NH, Geleen, NL, Basel, CH
Source: SEC EDGAR, press monitoring, company profiles
4 manufacturing sites
StatusLimited
Multi-site operations (4 manufacturing sites)
Broad modality coverage (6 modalities)
Sites: Houston, TX, Portsmouth, NH, Geleen, NL, Basel, CH
Recent Press20 articles
Multi-site operations (4 manufacturing sites)
Broad modality coverage (6 modalities)
Lonza Biologics FDA Inspection History
2026-02
2025-09
2025-08
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-02-06 | Portsmouth, New Hampshire | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 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 Jul 04, 2026
Lonza Biologics 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 Biologics 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 Jul 04, 2026
Lonza Biologics 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 Jul 04, 2026
Clinical Activity 1 studies
Source: ClinicalTrials.gov · Retrieved Jul 04, 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 Biologics
How many FDA inspections does Lonza Biologics have on record?
CDMO Signal tracks 3 FDA inspections for Lonza Biologics, sourced from the FDA inspection database. See the full inspection history above.
Has Lonza Biologics received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Lonza Biologics.
Does Lonza Biologics hold EMA or MHRA GMP certificates?
CDMO Signal tracks 3 EMA and 5 MHRA GMP certificates for Lonza Biologics.
How many clinical programs is Lonza Biologics linked to?
Lonza Biologics is associated with 1 clinical trial in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Lonza Biologics's CDMO Signal Score?
Lonza Biologics has a Signal Score of 69/100, based on quality, operations, financial stability, and capacity data.
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