GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services)
Osaka, Japan
Program data pending ClinicalTrials.gov matching
57.5
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
✓ Press (11)
○ EMA GMP
✓ MHRA GMP (1)
Quick Facts: GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services)
- Signal Score
- 57.5/100
- Quality Compliance
- Assessment pending
- Headquarters
- Osaka, Japan
- Modalities
- Oligonucleotide, Custom DNA/RNA Synthesis
- 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 GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services)
Auto-created by AI matchmaker. Data verification pending.
Signal Score & Pillar Breakdown
Quality Compliance
—
No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.
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, Custom DNA/RNA Synthesis
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
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity
55.0
Manufacturing site information being gathered
Modalities: Oligonucleotide, Custom DNA/RNA Synthesis
Capacity assessment: 55.0/100
Source: SEC EDGAR, press monitoring, company profiles
Profile-based capacity assessment
Recent Press11 articles
Manufacturing site information being gathered
Modalities: Oligonucleotide, Custom DNA/RNA Synthesis
Capacity assessment: 55.0/100
GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services) 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."
GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services) 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 Aug 22, 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
Frequently Asked Questions About GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services)
Does GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services) hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 MHRA GMP certificate for GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services).
What is GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services)'s CDMO Signal Score?
GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services) has a Signal Score of 58/100, based on quality, operations, financial stability, and capacity data.
Evaluating GeneDesign, Inc. (now part of Ajinomoto Bio-Pharma Services) for a manufacturing program?
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