Ajinomoto Bio-Pharma Services
San Diego, CA · Osaka, JP
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
85.6
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
✓ Press (11)
○ EMA GMP
✓ MHRA GMP (1)
Quick Facts: Ajinomoto Bio-Pharma Services
- Signal Score
- 85.6/100 (as of 2026-04-29)
- Quality Compliance
- 100.0/100 — No FDA inspection records found for this manufacturer
- Headquarters
- San Diego, CA · Osaka, JP
- Modalities
- Oligonucleotide, Biologics, AAV
- Active Programs
- No ClinicalTrials.gov matches confirmed — 6 partnership announcements in press
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Ajinomoto Bio-Pharma Services
Acquired Forge Biologics. Expanding into CGT.
Signal Score & Pillar Breakdown
Quality Compliance
100.0
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Source: FDA Data Dashboard
No FDA inspection records found for this manufacturer · Quality score requires FDA inspection data
FDA InspectionsNo US records on file
MHRA GMP Certificates1 on record
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer. 6 partnership announcements found in press monitoring.
Programs
— no verified data
Sponsors— no verified data
ModalitiesOligonucleotide, Biologics, AAV
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Partnership Announcements (from press monitoring)
Financial Stability
75.0
Strong parent backing: Ajinomoto Co. (2802.T)
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Strong parent backing: Ajinomoto Co. (2802.T)
Capacity
71.0
2 manufacturing sites
Strong partnership activity (6 articles)
Regulatory milestones (4 articles)
Sites: San Diego, CA, Osaka, Japan
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
Recent Press11 articles
2 manufacturing sites
Strong partnership activity (6 articles)
Regulatory milestones (4 articles)
FDA 483 Findings 14 observations · 2025-09-17 → 2025-10-14 ?
By subsystem
By severity
- 3 — Moderate: 2
- 2 — Minor: 12
- Repeat observations: 0
Most severe findings
-
Lack of or inadequate procedures
"Procedures for corrective and preventive action have not been established."
-
Process preventive controls - Appropriate (Adequate)
"Your written process preventive control, monitoring and verification procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control."
-
Label to bear a unique device identifier
"The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830."
MHRA GMP Compliance 1 certificates
2014-06
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 33833 Insp GMP 33833/586518-0001[H] | AJINOMOTO ALTHEA INCORPORATED | 92121-1205 | 2014-06-19 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved May 20, 2026
Recent News 11 articles
Piramal Pharma Solutions partners with Ajinomoto Bio-Pharma Services to support ADC development and manufacturing - BioSpectrum India
Piramal Pharma Solutions partners with Ajinomoto Bio-Pharma Services to support ADC development and manufacturing BioSpectrum India
Piramal Pharma Solutions partners with Ajinomoto Bio-Pharma Services to support ADC development and manufacturing - BioSpectrum India
Piramal Pharma Solutions partners with Ajinomoto Bio-Pharma Services to support ADC development and manufacturing BioSpectrum India
Piramal Pharma, Ajinomoto Bio-Pharma collaborate to accelerate ADC development - Indian Pharma Post
Piramal Pharma, Ajinomoto Bio-Pharma collaborate to accelerate ADC development Indian Pharma Post
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing - Yahoo Finance
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing Yahoo Finance
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing - PA Media
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing PA Media
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing - acrofan.com
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing acrofan.com
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing - digitalmore.co
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing digitalmore.co
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing - PR Newswire
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and Manufacturing PR Newswire
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and... - lokmattimes.com
Piramal Pharma Solutions and Ajinomoto Bio-Pharma Services Collaborate to Support ADC Development and... lokmattimes.com
Piramal Pharma Solutions und Ajinomoto Bio-Pharma Services arbeiten zusammen, um die Entwicklung und Herstellung von ADCs zu unterstützen - PR Newswire
Piramal Pharma Solutions und Ajinomoto Bio-Pharma Services arbeiten zusammen, um die Entwicklung und Herstellung von ADCs zu unterstützen PR Newswire
Piramal Pharma, Ajinomoto Bio-Pharma collaborate to accelerate ADC development - Indian Pharma Post
Piramal Pharma, Ajinomoto Bio-Pharma collaborate to accelerate ADC development Indian Pharma Post
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