AGC Biologics

Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
CAR-T Cell Therapy AAV Lentiviral
2 confirmed programs · 1 sponsors · Last scored 2026-04-02
80.2
Signal Score
✓ FDA Inspections (1) ✓ Clinical Trials (2) ○ SEC Filings ✓ Press (7) ✓ EMA GMP (15) ○ MHRA GMP

Quick Facts: AGC Biologics

Signal Score
80.2/100 (as of 2026-04-02)
Quality Compliance
99.9/100
Headquarters
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
Modalities
CAR-T, Cell Therapy, AAV, Lentiviral
Active Programs
2 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 99.9
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-04-18)
EMA GMP Certificates15 on record
Operations 60.0
2 active programs across 1 sponsors
Modalities: Cell Therapy, Lentiviral, CAR-T, AAV
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
2 active programs across 1 sponsors · Modalities: Cell Therapy, Lentiviral, CAR-T, AAV · 2 programs in advanced phases (Phase 2/3)
Programs 2
Sponsors1
ModalitiesCAR-T, Cell Therapy, AAV, Lentiviral
2 active programs across 1 sponsors
Modalities: Cell Therapy, Lentiviral, CAR-T, AAV
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
NCT04097301 Study of CAR T-cell Therapy in Acute Myeloid Leukemia and... PHASE1/PHASE2 Terminated
NCT00483509 Study of NGR-hTNF in Combination With Doxorubicin in Patients... PHASE2 Completed
Source: ClinicalTrials.gov · Retrieved Apr 05, 2026
Financial Stability 75.0
Strong parent backing: AGC Inc. (Japan)
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Strong parent backing: AGC Inc. (Japan)
Capacity 76.0
3 manufacturing sites
Broad modality coverage (4 modalities)
Active facility expansion (2 articles)
Sites: Longmont, CO, Milan, Italy, Chiba, Japan
Source: SEC EDGAR, press monitoring, company profiles
3 manufacturing sites
StatusAvailable
3 manufacturing sites
Broad modality coverage (4 modalities)
Active facility expansion (2 articles)
Sites: Longmont, CO, Milan, Italy, Chiba, Japan
Recent Press7 articles
3 manufacturing sites
Broad modality coverage (4 modalities)
Active facility expansion (2 articles)

FDA Inspection History

2025-04
NAI VAI OAI
Date Site Type Observations Classification
2025-04-18 Bothell, Washington Blood and Blood Products No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Apr 05, 2026

EMA GMP Compliance 15 certificates

2025-10
2025-05
2025-05
2025-03
2025-03
2024-08
2024-08
2023-06
2023-06
2023-06
2023-06
2022-02
2021-04
2021-04
2021-04
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
IT/54/H/2026 AGC Biologics S.p.A. Italy 2025-10-23 COMPLIANT
DK H 10001274 AGC Biologics A/S Denmark 2025-05-13 COMPLIANT
DK IMP 10001275 AGC Biologics A/S Denmark 2025-05-13 COMPLIANT
DE_BW_01_GMP_2025_0203 AGC Biologics GmbH Germany 2025-03-13 COMPLIANT
DE_BW_01_GMP_2025_0077 AGC Biologics GmbH Germany 2025-03-13 COMPLIANT
DK H 10001033 AGC Biologics A/S Denmark 2024-08-22 COMPLIANT
DK IMP 10001034 AGC Biologics A/S Denmark 2024-08-22 COMPLIANT
DK H 10000841 AGC Biologics A/S Denmark 2023-06-29 COMPLIANT
DK API-H 10000840 AGC Biologics A/S Denmark 2023-06-29 COMPLIANT
DK H 10000842 AGC Biologics A/S Denmark 2023-06-29 COMPLIANT
DK IMP 10000843 AGC Biologics A/S Denmark 2023-06-29 COMPLIANT
DE_BW_01_GMP_2022_0053 AGC Biologics GmbH Germany 2022-02-23 COMPLIANT
DK H 10000195 AGC Biologics A/S Denmark 2021-04-22 COMPLIANT
DK IMP 10000196 AGC Biologics A/S Denmark 2021-04-22 COMPLIANT
DK API-H 10000194 AGC Biologics A/S Denmark 2021-04-22 COMPLIANT
Source: EMA EudraGMDP · Retrieved Apr 05, 2026

Recent News 7 articles

facility_expansion 2026-03-10
AGC Biologics Expands Capacity at Berkeley, California Facility | Libero Quotidiano.it - Libero Quotidiano
AGC Biologics Expands Capacity at Berkeley, California Facility | Libero Quotidiano.it  liberoquotidiano.it
Source →
facility_expansion 2026-03-10
AGC Biologics Expands Capacity at Berkeley, California Facility | Libero Quotidiano.it - Libero Quotidiano
AGC Biologics Expands Capacity at Berkeley, California Facility | Libero Quotidiano.it  Libero Quotidiano
Source →
general 2026-03-02
Continuous Manufacturing Market Trends and Global Forecasts, 2035 Featuring Key Players - AbbVie, Abzena, AGC Biologics, Boehringer Ingelheim, Corden Pharma, Glatt, Kaneka, Phlow, and Wuxi Biologics - Yahoo Finance UK
Continuous Manufacturing Market Trends and Global Forecasts, 2035 Featuring Key Players - AbbVie, Abzena, AGC Biologics, Boehringer Ingelheim, Corden Pharma, Glatt, Kaneka, Phlow, and Wuxi Biologics  Yahoo Finance UK
Source →
general 2026-03-02
Continuous Manufacturing Market Trends and Global Forecasts, 2035 Featuring Key Players - AbbVie, Abzena, AGC Biologics, Boehringer Ingelheim, Corden Pharma, Glatt, Kaneka, Phlow, and Wuxi Biologics - Yahoo Finance
Continuous Manufacturing Market Trends and Global Forecasts, 2035 Featuring Key Players - AbbVie, Abzena, AGC Biologics, Boehringer Ingelheim, Corden Pharma, Glatt, Kaneka, Phlow, and Wuxi Biologics  Yahoo Finance
Source →
general 2026-02-03
AGC Biologics Seattle Site Now Certified to Manufacture Biologics for Largest Pharmaceutical Market in South America - The Joplin Globe
AGC Biologics Seattle Site Now Certified to Manufacture Biologics for Largest Pharmaceutical Market in South America  The Joplin Globe
Source →
general 2026-02-03
AGC Biologics Seattle Site Now Certified to Manufacture Biologics for Largest Pharmaceutical Market in South America - Business Wire
AGC Biologics Seattle Site Now Certified to Manufacture Biologics for Largest Pharmaceutical Market in South America  Business Wire
Source →
regulatory 2026-02-03
AGC Biologics Seattle Site Receives Anvisa GMP Certification - Contract Pharma
AGC Biologics Seattle Site Receives Anvisa GMP Certification  Contract Pharma
Source →
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