How We Score
The Signal Score is a composite assessment of a CDMO's ability to deliver quality CGT products reliably. Every score is grounded in verifiable public data — never surveys, never self-reported metrics. CDMOs cannot pay to influence their score.
Composite Score (0–100)
Each CDMO receives a weighted composite across four pillars. Scores recalculate as new data arrives — typically daily for FDA actions, weekly for operational and capacity signals.
Quality Compliance 35%
- FDA 483 observations (count, severity, recency)
- Warning letters (3-year lookback)
- Inspection classifications (NAI/VAI/OAI)
- Data integrity findings (heavily penalized)
- Consecutive clean inspection streaks
Operations 25%
- Active CGT program count
- Sponsor diversity (concentration risk)
- Modality breadth and specialization
- Phase advancement ratio
- Clinical trial phase distribution
Financial Stability 20%
- Public vs. private status
- Parent company financial health
- CGT segment revenue (SEC filings)
- M&A stability
- Regulatory risk (BIOSECURE Act)
Capacity Intelligence 20%
- Facility count and coverage
- Expansion announcements
- Press release patterns
- SEC capacity investment mentions
- Modality breadth as indicator
Data Sources
ClinicalTrials.gov — 30,000+ CGT studies cross-referenced to identify CDMO manufacturing relationships.
SEC EDGAR — 10-K, 10-Q, 8-K filings for public CDMO parents. CGT revenue, facility investments, risk factors.
Press Monitoring — Partnerships, expansions, leadership changes, regulatory milestones. Categorized and scored.
How Often Is Data Updated?
| Source | Frequency | Last Refresh |
|---|---|---|
| FDA Inspections | Daily (weekdays) | 2026-03-16 |
| FDA Warning Letters | Daily (weekdays) | 2026-03-17 |
| ClinicalTrials.gov | Weekly (Mon & Thu) | 2026-03-16 |
| SEC EDGAR Filings | Weekly (Mon & Thu) | 2026-03-16 |
| Press Monitoring | Daily | 2026-03-17 |
What We Don't Score
Self-reported capabilities, survey data, marketing materials, paid directory listings. If it can't be independently verified, it doesn't enter the model.
Score Statuses
Scored — Full composite across all pillars. Requires quality or operational pillar data and sufficient signals for a composite score.
Partial — Scored on 2-3 pillars. Typically missing financial or capacity data. Score shown as "Partial" on CDMO profiles.
Profiled — CDMO profile with modalities and basic data. Scoring data is being gathered.
CDMO Types
Pure CDMO — Dedicated contract manufacturers whose primary business is manufacturing for sponsors.
Hybrid — Companies with both internal pipelines and contract manufacturing arms (e.g., Novartis, Oxford Biomedica).
Platform — Technology platform providers that enable or automate manufacturing (e.g., Cellares, MaxCyte).
Reagent/Material Supplier — GMP reagent, media, or materials suppliers critical to CGT manufacturing.
National Center — Government-backed or non-profit manufacturing centers (e.g., Cell and Gene Therapy Catapult, CCRM).