Lonza Biologics

Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
AAV Lentiviral Cell Therapy mRNA
1 confirmed programs · 1 sponsors · Last scored 2026-04-02
73.8
Signal Score
✓ FDA Inspections (1) ✓ Clinical Trials (1) ○ SEC Filings ✓ Press (20) ✓ EMA GMP (3) ✓ MHRA GMP (4)

Quick Facts: Lonza Biologics

Signal Score
73.8/100 (as of 2026-04-02)
Quality Compliance
98.0/100
Headquarters
Houston, TX · Portsmouth, NH · Geleen, NL · Basel, CH
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

Signal Score & Pillar Breakdown

Quality Compliance 98.0
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2026-02-06)
EMA GMP Certificates3 on record
MHRA GMP Certificates4 on record
Operations 50.0
1 active programs across 1 sponsors
Modalities: AAV, mRNA, Cell Therapy, Lentiviral
Source: ClinicalTrials.gov
1 active programs across 1 sponsors · Modalities: AAV, mRNA, Cell Therapy, Lentiviral
Programs 1
Sponsors1
ModalitiesAAV, Lentiviral, Cell Therapy, mRNA
1 active programs across 1 sponsors
Modalities: AAV, mRNA, Cell Therapy, Lentiviral
Source: ClinicalTrials.gov facility matching
NCT04809766 Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment... PHASE1 Terminated
Source: ClinicalTrials.gov · Retrieved Apr 05, 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 (4 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 (4 modalities)
Sites: Houston, TX, Portsmouth, NH, Geleen, NL, Basel, CH
Recent Press20 articles
Multi-site operations (4 manufacturing sites)
Broad modality coverage (4 modalities)

FDA Inspection History

2026-02
NAI VAI OAI
Date Site Type Observations Classification
2026-02-06 Portsmouth, New Hampshire Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Apr 05, 2026

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 Apr 05, 2026

MHRA GMP Compliance 4 certificates

2025-12
2025-12
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 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 Apr 05, 2026

Clinical Activity 1 studies

NCT04809766 Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic... PHASE1 Terminated
Source: ClinicalTrials.gov · Retrieved Apr 05, 2026

Recent News 20 articles

partnership 2026-04-02
ImmuneOncia Therapeutics and Lonza collaborate to manufacture Danburstotug - Manufacturing Chemist
ImmuneOncia Therapeutics and Lonza collaborate to manufacture Danburstotug  Manufacturing Chemist
Source →
general 2026-03-31
Lonza links up with Torqur on bimiralisib manufacturing - The Pharma Letter
Lonza links up with Torqur on bimiralisib manufacturing  The Pharma Letter
Source →
general 2026-03-31
Lonza’s Board Renewal: Enhanced Governance Strengthening a Strong CDMO Investment Rationale - Bitget
Lonza’s Board Renewal: Enhanced Governance Strengthening a Strong CDMO Investment Rationale  Bitget
Source →
general 2026-03-31
Lonza Expands Bioprocessing Capabilities With Media Development Lab In Singapore - BioPharma APAC
Lonza Expands Bioprocessing Capabilities With Media Development Lab In Singapore  BioPharma APAC
Source →
general 2026-03-30
Lonza Group AG Stock: A Key Player in Biopharma Contract Manufacturing for North American Investors - AD HOC NEWS
Lonza Group AG Stock: A Key Player in Biopharma Contract Manufacturing for North American Investors  ad-hoc-news.de
Source →
general 2026-03-30
ImmuneOncia, Lonza Sign Manufacturing Pact for Late‑Stage Antibody Program - Contract Pharma
ImmuneOncia, Lonza Sign Manufacturing Pact for Late‑Stage Antibody Program  Contract Pharma
Source →
general 2026-03-30
Lonza Group AG Stock: Leading CDMO in Biopharma with Strong Growth Outlook for North American Invest - ad-hoc-news.de
Lonza Group AG Stock: Leading CDMO in Biopharma with Strong Growth Outlook for North American Invest  ad-hoc-news.de
Source →
general 2026-03-30
Lonza Group AG Stock: A Key Player in Biopharma Contract Manufacturing for North American Investors - AD HOC NEWS
Lonza Group AG Stock: A Key Player in Biopharma Contract Manufacturing for North American Investors  AD HOC NEWS
Source →
general 2026-03-30
Lonza Group AG Stock: Leading CDMO in Biopharma with Strong Growth Outlook for North American Invest - AD HOC NEWS
Lonza Group AG Stock: Leading CDMO in Biopharma with Strong Growth Outlook for North American Invest  AD HOC NEWS
Source →
facility_expansion 2026-03-28
StarLIMS: MODA Platform Acquisition From Lonza To Expand Manufacturing And Quality Control Capabilities - Pulse 2.0
StarLIMS: MODA Platform Acquisition From Lonza To Expand Manufacturing And Quality Control Capabilities  Pulse 2.0
Source →
general 2026-03-28
Lonza Group AG Stock: A Key Player in Biopharma Manufacturing for North American Investors - AD HOC NEWS
Lonza Group AG Stock: A Key Player in Biopharma Manufacturing for North American Investors  ad-hoc-news.de
Source →
general 2026-03-28
Lonza Group AG Stock: A Key Player in Biopharma Manufacturing for North American Investors - AD HOC NEWS
Lonza Group AG Stock: A Key Player in Biopharma Manufacturing for North American Investors  AD HOC NEWS
Source →
general 2026-03-27
Lonza Media Development Lab Set Up in Singapore - Genetic Engineering and Biotechnology News
Lonza Media Development Lab Set Up in Singapore  genengnews.com
Source →
general 2026-03-27
Lonza opens Media Development Lab in Singapore for cell culture media optimisation - BioSpectrum Asia
Lonza opens Media Development Lab in Singapore for cell culture media optimisation  BioSpectrum Asia
Source →
general 2026-03-27
Lonza Launches Media Development Lab In Singapore To Strengthen Scalable Bioprocessing - biospectrumasia.com
Lonza Launches Media Development Lab In Singapore To Strengthen Scalable Bioprocessing  biospectrumasia.com
Source →
regulatory 2026-03-27
Lonza launches Singapore Media Development Lab to cut biomanufacturing risk - Indian Pharma Post
Lonza launches Singapore Media Development Lab to cut biomanufacturing risk  Indian Pharma Post
Source →
general 2026-03-26
Lonza Group AG stock slips amid broader Swiss market weakness on SIX Swiss Exchange - AD HOC NEWS
Lonza Group AG stock slips amid broader Swiss market weakness on SIX Swiss Exchange  AD HOC NEWS
Source →
general 2026-03-26
BRIEF—Lonza launches new development lab in Singapore - The Pharma Letter
BRIEF—Lonza launches new development lab in Singapore  The Pharma Letter
Source →
general 2026-03-26
Lonza, Genetix Bio Extend Commercial Mfg. Pact for ZYNTEGLO - Contract Pharma
Lonza, Genetix Bio Extend Commercial Mfg. Pact for ZYNTEGLO  Contract Pharma
Source →
general 2026-03-25
Platform from Lonza, Expanding Deeper Into Manufacturing Operations & Quality Control - Business Wire
Platform from Lonza, Expanding Deeper Into Manufacturing Operations & Quality Control  Business Wire
Source →
Represent this organization? Contact us to verify or update this profile.
See all CDMOs in:
AAV CDMOs → Lentiviral CDMOs → Cell Therapy CDMOs → mRNA CDMOs →

Similar CDMOs

Lonza
Basel, Switzerland
Signal Score: 78.6
AAV, Lentiviral, Cell Therapy, mRNA
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
Signal Score: 92.2
CAR-T, Cell Therapy, Gene Editing, Plasmid, AAV, Lentiviral
ReciBioPharm
Keele, UK · Sodertalje, SE
Signal Score: 88.0
AAV, Lentiviral, Plasmid, mRNA
AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
Signal Score: 80.2
CAR-T, Cell Therapy, AAV, Lentiviral
NecstGen
Leiden, NL
Signal Score: 78.1
AAV, Lentiviral, Cell Therapy