Cedars-Sinai Biomanufacturing

Los Angeles, CA

National Center

Cell Therapy Gene Editing

32 confirmed programs · 18 sponsors · Last scored 2026-04-29

79.1

Signal Score

✓ FDA Inspections (1) ✓ Clinical Trials (32) ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Cedars-Sinai Biomanufacturing

Signal Score: 79.1/100 (as of 2026-04-29)
Quality Compliance: 100.0/100
Headquarters: Los Angeles, CA
Modalities: Cell Therapy, Gene Editing
Active Programs: 32 confirmed from ClinicalTrials.gov across 18 sponsors
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By: CDMO Signal — independent CDMO intelligence platform

About Cedars-Sinai Biomanufacturing

CDMO.

Signal Score & Pillar Breakdown

Quality Compliance

FDA Inspections1 on record

Warning Letters0

Last InspectionNo Action Indicated (NAI) (2025-03-14)

Operations

32 active programs across 18 sponsors · Modalities: Cell Therapy, Gene Editing · 14 programs in advanced phases (Phase 2/3)

Programs 32

Sponsors18

ModalitiesCell Therapy, Gene Editing

32 active programs across 18 sponsors

Modalities: Cell Therapy, Gene Editing

14 programs in advanced phases (Phase 2/3)

Source: ClinicalTrials.gov facility matching

NCT06208878 A Long-term Follow-up Study of Subjects Who Received CRISPR... NA Enrolling By Invitation

NCT05781152 Clinical, Imaging, and Endoscopic Outcomes of Children Newly... PHASE4 Recruiting

NCT05819359 Efficacy, Safety, Tolerability, Pharmacodynamics, and... PHASE2 Active Not Recruiting

NCT05487599 A Clinical Trial of PR001 (LY3884961) in Patients With... PHASE1/PHASE2 Recruiting

NCT05306457 CNS10-NPC-GDNF Delivered to the Motor Cortex for ALS PHASE1 Active Not Recruiting

NCT05098132 Study of STK-012 Alone and With Other Treatments in Patients... PHASE1/PHASE2 Recruiting

NCT04284293 CNS10-NPC for the Treatment of RP PHASE1 Active Not Recruiting

NCT04681131 CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC PHASE2 Completed

NCT04669899 Study of JTX-8064, as Monotherapy and in Combination With a... PHASE1/PHASE2 Completed

NCT03751709 Blinatumomab Plus HLA-Mismatched Cellular Therapy for... PHASE1 Completed

View all 32 programs →

Source: ClinicalTrials.gov · Retrieved Jul 04, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Parent company: Cedars-Sinai Medical Center

Financial assessment: 68.0/100

Capacity

1 manufacturing site

1 manufacturing site: Los Angeles, CA

Modalities: Cell Therapy, Gene Editing

Capacity assessment: 58.0/100

Cedars-Sinai Biomanufacturing FDA Inspection History

2025-03

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-03-14	West Hollywood, California	Blood and Blood Products	No	No Action Indicated (NAI)

Source: FDA Data Dashboard · Retrieved Jul 04, 2026

Clinical Activity 32 studies

NCT06208878 A Long-term Follow-up Study of Subjects Who Received CRISPR CAR T Cellular Therapies NA Enrolling By Invitation NCT05781152 Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With... PHASE4 Recruiting NCT05819359 Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of... PHASE2 Active Not Recruiting NCT05487599 A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral... PHASE1/PHASE2 Recruiting NCT05306457 CNS10-NPC-GDNF Delivered to the Motor Cortex for ALS PHASE1 Active Not Recruiting NCT05098132 Study of STK-012 Alone and With Other Treatments in Patients With Advanced... PHASE1/PHASE2 Recruiting NCT04284293 CNS10-NPC for the Treatment of RP PHASE1 Active Not Recruiting NCT04681131 CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC PHASE2 Completed NCT04669899 Study of JTX-8064, as Monotherapy and in Combination With a PD-1 Inhibitor,... PHASE1/PHASE2 Completed NCT03751709 Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL PHASE1 Completed NCT04224558 Stem Cell Transplantation in Crohn's Disease PHASE1/PHASE2 Recruiting NCT04035434 A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or... PHASE1/PHASE2 Terminated NCT04048577 A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week... PHASE4 Unknown NCT03859388 Longitudinal Changes in Donor-Derived Cell-Free DNA With Tocilizumab... NA Active Not Recruiting NCT03508609 Safety and Potential Bioactivity of CLBS16 in Patients With Coronary... PHASE2 Completed NCT03145298 ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy PHASE1 Completed NCT02943850 CNS10-NPC-GDNF for the Treatment of ALS PHASE1 Completed NCT02684006 A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell... PHASE3 Completed NCT02574390 Answer ALS: Individualized Initiative for ALS Discovery NA Completed NCT02534376 Cellular Effect of Cholesterol-Lowering Prior to Prostate Removal EARLY_PHASE1 Completed

+ 12 more studies

Source: ClinicalTrials.gov · Retrieved Jul 04, 2026

Frequently Asked Questions About Cedars-Sinai Biomanufacturing

How many FDA inspections does Cedars-Sinai Biomanufacturing have on record?

CDMO Signal tracks 1 FDA inspection for Cedars-Sinai Biomanufacturing, sourced from the FDA inspection database. See the full inspection history above.

Has Cedars-Sinai Biomanufacturing received an FDA warning letter?

CDMO Signal has no FDA warning letters on record for Cedars-Sinai Biomanufacturing.

How many clinical programs is Cedars-Sinai Biomanufacturing linked to?

Cedars-Sinai Biomanufacturing is associated with 32 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.

What is Cedars-Sinai Biomanufacturing's CDMO Signal Score?

Cedars-Sinai Biomanufacturing has a Signal Score of 79/100, based on quality, operations, financial stability, and capacity data.

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