Novartis Contract Manufacturing
Morris Plains, NJ · Stein, CH
Hybrid — also manufactures internal programs
413 confirmed programs
· 116 sponsors
· Last scored 2026-03-15
66.3
Signal Score
✓ FDA Inspections (8)
✓ Clinical Trials (278)
✓ SEC Filings (28)
✓ Press (1)
Quick Facts: Novartis Contract Manufacturing
- Signal Score
- 66.3/100 (as of 2026-03-15)
- Quality Compliance
- 60.0/100
- Headquarters
- Morris Plains, NJ · Stein, CH
- Modalities
- CAR-T
- Active CGT Programs
- 413 confirmed from ClinicalTrials.gov across 116 sponsors
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CGT manufacturing intelligence platform
Signal Score & Pillar Breakdown
Quality Compliance
60.0
FDA Inspections8 on record
Warning Letters0
Last InspectionOfficial Action Indicated (OAI) (2025-09-16)
Operations
86.9
413 active programs across 116 sponsors
Modalities: CAR-T
275 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
413 active programs across 116 sponsors · Modalities: CAR-T · 275 programs in advanced phases (Phase 2/3)
Programs
413
Sponsors116
ModalitiesCAR-T
413 active programs across 116 sponsors
Modalities: CAR-T
275 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT07421167
A Study to Assess the Tolerability of Ianalumab (VAY736) With...
PHASE2
Not Yet Recruiting
NCT07468071
Rollover Study for Participants Who Have Been Treated With...
PHASE1/PHASE2
Not Yet Recruiting
View all 278 programs →
Source: ClinicalTrials.gov · Retrieved Mar 20, 2026
Financial Stability
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
28 SEC filings with CGT mentions on record
SEC Filings28 with CGT mentions
Private company
Financial assessment: 60.0/100
Capacity
58.0
2 CGT manufacturing sites
Sites: Morris Plains, NJ, Stein, CH
Source: SEC EDGAR, press monitoring, company profiles
2 CGT manufacturing sites
StatusConstrained
2 CGT manufacturing sites
Sites: Morris Plains, NJ, Stein, CH
Recent Press1 articles
2 CGT manufacturing sites
FDA Inspection History
2025-09
2025-06
2025-03
2024-11
2024-08
2024-08
2024-07
2024-06
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-16 | Selaqui | Drug Quality Assurance | No | Official Action Indicated (OAI) |
| 2025-06-25 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2025-03-03 | East Hanover, New Jersey | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-11-19 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-08-29 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-08-08 | Morris Plains, New Jersey | Human Cellular, Tissue, and Gene Therapies | Yes | Voluntary Action Indicated (VAI) |
| 2024-07-12 | Ahmedabad | Bioresearch Monitoring | No | No Action Indicated (NAI) |
| 2024-06-27 | East Hanover, New Jersey | Bioresearch Monitoring | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Mar 20, 2026
Clinical Activity 278 studies
NCT07448610
ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy...
PHASE4
Not Yet Recruiting
NCT07421167
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's...
PHASE2
Not Yet Recruiting
NCT07468071
Rollover Study for Participants Who Have Been Treated With and Are...
PHASE1/PHASE2
Not Yet Recruiting
NCT07039422
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and...
PHASE2
Recruiting
NCT07378969
A Non-Interventional Study PASS to Characterize Secondary Malignancies of...
NA
Not Yet Recruiting
NCT07006727
Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing...
PHASE1
Recruiting
NCT06855277
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants...
PHASE3
Recruiting
NCT07048197
A Study to Assess Safety, Cellular Kinetics and Exploratory Efficacy of...
PHASE1/PHASE2
Recruiting
NCT07029555
An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis
PHASE1
Recruiting
NCT06910813
DFT383 in Pediatric Participants With Nephropathic Cystinosis
PHASE1/PHASE2
Recruiting
NCT06711887
Phase III Extension Study of Efficacy and Safety of Ianalumab With or...
PHASE3
Recruiting
NCT06704269
Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in...
PHASE1/PHASE2
Recruiting
NCT06868290
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe...
PHASE2
Recruiting
NCT06617793
An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of...
PHASE1/PHASE2
Recruiting
NCT06665256
Phase 2 Study of Rapcabtagene Autoleucel in Myositis
PHASE2
Recruiting
NCT06675864
Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease...
PHASE1/PHASE2
Recruiting
NCT06439082
A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg)...
PHASE3
Recruiting
NCT06562192
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast...
PHASE1
Recruiting
NCT06470048
A Clinical Study to Evaluate Ianalumab in Participants With Diffuse...
PHASE2
Recruiting
NCT06376253
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
PHASE1
Terminated
+ 258 more studies
Source: ClinicalTrials.gov · Retrieved Mar 20, 2026
Financial Intelligence
"We face a challenge to attract and retain top talent in several areas, including biology, immunology, chemistry, clinical development, drug manufacturing, data, digital and IT, including AI, oncology, and advanced therapy platforms (i.e., gene and cell therapy, radioligand therapy, and xRNA)."
"In addition, we manufacture and sell a number of sterile products, biologic products, and products that involve advanced therapy platforms, such as gene and cell therapy, radioligand therapy, and xRNA, or require a supply of highly specialized raw materials, such as cell lines, tissue samples, bacteria, viral strains, and radioisotopes."
"The T315I mutation causes resistance to most available TKI therapies, and, as a result, patients with this mutation would otherwise have limited treatment options
•
Zolgensma
(onasemnogene abeparvovec)/
Itvisma
(onasemnogene abeparvovec-brve) is a one-time gene therapy designed to address the genetic root cause of spinal muscular atrophy (SMA) by replacing the function of the missing or nonworking SMN1 gene."
"“The SMA disease landscape has dramatically changed over the last
six years, when the first gene therapy was approved."
"Novartis has an exclusive, worldwide license with Nationwide Children's Hospital to both the intravenous
and intrathecal delivery of adeno-associated virus 9 (AAV9) gene replacement therapy for the treatment of all types of SMA; an exclusive,
worldwide license from REGENXBIO for any recombinant AAV vector in its intellectual property portfolio for the
in vivo
gene replacement
therapy treatment of SMA in humans; an exclusive, worldwide licensing agreement with Généthon for
in vivo
delivery
of AAV"
"We face a challenge to attract and retain top talent in several areas, including biology, immunology, chemistry, clinical development, drug manufacturing, data, digital and IT, oncology, and advanced therapy platforms (i.e., gene and cell therapy, radioligand therapy and xRNA) and to maintain and strengthen our employer reputation."
"In addition, we manufacture and sell a number of sterile products, biologic products and products that involve advanced therapy platforms, such as gene and cell therapy, radioligand therapy, and xRNA, all of which are particularly complex and involve highly specialized manufacturing technologies."
"In addition, we manufacture and sell a number of sterile products, biologic products, and products that involve advanced therapy platforms, such as gene and cell therapy, radioligand therapy, and xRNA, all of which are particularly complex and involve highly specialized manufacturing technologies."
"OAV101 IT is the first investigational
gene therapy to provide clinical benefit in treatment-naïve patients with SMA aged two
and older with a positive risk benefit profile"
"7
The results from the
Phase III STEER study add to the clinical data and emerging real-world evidence for the use
of one-time gene therapy to treat SMA."
"About
OAV101 IT
Intrathecal onasemnogene abeparvovec (OAV101 IT) is an investigational,
one-time gene therapy for patients with spinal muscular atrophy (SMA)."
Source: SEC EDGAR · Retrieved Mar 20, 2026
Recent News 1 articles
Novartis Announces New Radioligand Therapy Manufacturing Facility In Denton, Texas - Bioprocess Online
Novartis Announces New Radioligand Therapy Manufacturing Facility In Denton, Texas Bioprocess Online
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