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.
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

  • Documentation & Records 6 (42.9%)
  • Other 4 (28.6%)
  • Equipment & Facilities 2 (14.3%)
  • CAPA 2 (14.3%)

By severity

  • 3 — Moderate: 2
  • 2 — Minor: 12
  • Repeat observations: 0

Most severe findings

  • Moderate (3) CAPA 2025-10-14 21 CFR 820.100(a)
    Lack of or inadequate procedures

    "Procedures for corrective and preventive action have not been established."

  • Moderate (3) CAPA 2025-09-17 21 CFR 117.135(c)(1)
    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."

  • Minor (2) Other 2025-10-14 21 CFR 801.20(a)
    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

regulatory 2026-04-18
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
regulatory 2026-04-18
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
regulatory 2026-04-17
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
partnership 2026-04-16
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
partnership 2026-04-16
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
partnership 2026-04-16
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
partnership 2026-04-16
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
partnership 2026-04-16
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
partnership 2026-04-16
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
general 2026-04-16
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
regulatory 2026-04-16
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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