AGC Biologics

Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
CAR-T Cell Therapy AAV Lentiviral ADC Monoclonal Antibody Recombinant Protein
2 confirmed programs · 1 sponsors · Last scored 2026-04-29
79.9
Signal Score
✓ FDA Inspections (1) ✓ Clinical Trials (2) ○ SEC Filings ✓ Press (19) ✓ EMA GMP (23) ○ MHRA GMP

Quick Facts: AGC Biologics

Signal Score
79.9/100 (as of 2026-04-29)
Quality Compliance
98.6/100
Headquarters
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
Modalities
CAR-T, Cell Therapy, AAV, Lentiviral, ADC, Monoclonal Antibody, Recombinant Protein
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

About AGC Biologics

3 approved commercial cell therapies.

Signal Score & Pillar Breakdown

Quality Compliance 98.6
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-04-18)
EMA GMP Certificates23 on record
Operations 60.0
2 active programs across 1 sponsors
Modalities: Cell Therapy, AAV, Recombinant Protein, CAR-T, Lentiviral, ADC, Monoclonal Antibody
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
2 active programs across 1 sponsors · Modalities: Cell Therapy, AAV, Recombinant Protein, CAR-T, Lentiviral, ADC, Monoclonal Antibody · 2 programs in advanced phases (Phase 2/3)
Programs 2
Sponsors1
ModalitiesCAR-T, Cell Therapy, AAV, Lentiviral, ADC, Monoclonal Antibody, Recombinant Protein
2 active programs across 1 sponsors
Modalities: Cell Therapy, AAV, Recombinant Protein, CAR-T, Lentiviral, ADC, Monoclonal Antibody
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 Jul 04, 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 77.0
3 manufacturing sites
Broad modality coverage (7 modalities)
Facility expansion news detected
Strong partnership activity (3 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 (7 modalities)
Facility expansion news detected
Strong partnership activity (3 articles)
Sites: Longmont, CO, Milan, Italy, Chiba, Japan
Recent Press19 articles
3 manufacturing sites
Broad modality coverage (7 modalities)
Facility expansion news detected
Strong partnership activity (3 articles)

AGC Biologics 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 Jul 04, 2026

AGC Biologics EMA GMP Compliance 23 certificates

2026-05
2026-02
2026-02
2026-02
2026-02
2026-02
2026-02
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
2021-04
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
IT/123/H/2026 Agc Biologics S.p.A. Italy 2026-05-14 COMPLIANT
DK IMP 10001472 AGC Biologics A/S Denmark 2026-02-19 COMPLIANT
DK H 10001471 AGC Biologics A/S Denmark 2026-02-19 COMPLIANT
DK H 10001485 AGC Biologics A/S Denmark 2026-02-19 COMPLIANT
DK API-H 10001475 AGC Biologics A/S Denmark 2026-02-19 COMPLIANT
DK H 10001473 AGC Biologics A/S Denmark 2026-02-19 COMPLIANT
DK IMP 10001474 AGC Biologics A/S Denmark 2026-02-19 COMPLIANT
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
DK H 10000244 AGC Biologics A/S Denmark 2021-04-22 COMPLIANT
Source: EMA EudraGMDP · Retrieved Jul 04, 2026

Recent News 19 articles

general 2026-05-06
Novelty Nobility Expands AGC Biologics Deal to Take Product Candidate Through GMP Manufacturing - Genetic Engineering and Biotechnology News
Novelty Nobility Expands AGC Biologics Deal to Take Product Candidate Through GMP Manufacturing  Genetic Engineering and Biotechnology News
Source →
general 2026-05-04
Novelty Nobility Taps AGC Biologics to Further Develop Bispecific Drug Candidate - BioSpace
Novelty Nobility Taps AGC Biologics to Further Develop Bispecific Drug Candidate  BioSpace
Source →
general 2026-05-04
Novelty Nobility Taps AGC Biologics to Further Develop Bispecific Drug Candidate - GlobeNewswire
Novelty Nobility Taps AGC Biologics to Further Develop Bispecific Drug Candidate  GlobeNewswire
Source →
facility_expansion 2026-05-04
Novelty Nobility Expands Manufacturing Pact With AGC Biologics in Japan - Contract Pharma
Novelty Nobility Expands Manufacturing Pact With AGC Biologics in Japan  Contract Pharma
Source →
general 2026-05-04
AGC Biologics Expands Deal With Novelty Nobility For Antibody Production - Bernama
AGC Biologics Expands Deal With Novelty Nobility For Antibody Production  Bernama
Source →
regulatory 2026-05-04
Novelty Nobility Taps AGC Biologics to Further Develop Bispecific Drug Candidate - Indovizka.com
Novelty Nobility Taps AGC Biologics to Further Develop Bispecific Drug Candidate  Indovizka.com
Source →
general 2026-04-28
AGC Biologics Honoured For Leadership In Regulatory, Quality Compliance - Bernama
AGC Biologics Honoured For Leadership In Regulatory, Quality Compliance  Bernama
Source →
partnership 2026-04-28
AGC Biologics Wins 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance - riauone.com
AGC Biologics Wins 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance  riauone.com
Source →
general 2026-04-28
AGC Biologics Honoured For Leadership In Regulatory, Quality Compliance - Bernama
AGC Biologics Honoured For Leadership In Regulatory, Quality Compliance  Bernama
Source →
partnership 2026-04-27
AGC Biologics Wins 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance - GlobeNewswire
AGC Biologics Wins 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance  GlobeNewswire
Source →
partnership 2026-04-27
AGC Biologics Wins 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance - FinancialContent
AGC Biologics Wins 2026 Fierce Outsourcing Award for Leadership in Regulatory and Quality Compliance  FinancialContent
Source →
general 2026-04-15
AGC Biologics to expand CDMO capabilities in Japan with new $350M Yokohama site - megaproject.com
AGC Biologics to expand CDMO capabilities in Japan with new $350M Yokohama site  megaproject.com
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  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 →

Frequently Asked Questions About AGC Biologics

How many FDA inspections does AGC Biologics have on record?
CDMO Signal tracks 1 FDA inspection for AGC Biologics, sourced from the FDA inspection database. See the full inspection history above.
Has AGC Biologics received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for AGC Biologics.
Does AGC Biologics hold EMA or MHRA GMP certificates?
CDMO Signal tracks 23 EMA GMP certificates for AGC Biologics.
How many clinical programs is AGC Biologics linked to?
AGC Biologics is associated with 2 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is AGC Biologics's CDMO Signal Score?
AGC Biologics has a Signal Score of 80/100, based on quality, operations, financial stability, and capacity data.
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CAR-T CDMOs → Cell Therapy CDMOs → AAV CDMOs → Lentiviral CDMOs → ADC CDMOs → Recombinant Protein CDMOs →

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