How We Score
The Signal Score is a composite assessment of a CDMO's ability to deliver quality therapeutic 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 EMA, operational, and capacity signals.
Quality Compliance 35%
- FDA 483 observations weighted by subsystem and severity (data integrity = 6×, serious findings = 3×, minor procedural = 0.4×)
- Repeat observations (same site, same regulation within 36 months) weighted 2×
- Warning letters (3-year lookback)
- Inspection classifications (NAI/VAI/OAI)
- Consecutive clean inspection streaks
- EMA GMP certificates (active count, compliance status)
- EMA non-compliance statements (equivalent to OAI)
- MHRA GMP certificates (UK post-Brexit regulatory data)
- FDA + EMA + MHRA blended when multiple exist (weighted by record count)
Operations 25%
- Active 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
- 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
FDA 483 Citation Subsystems & Severity
The Quality Compliance pillar weights every FDA 483 observation by what kind of issue it is (subsystem) and how serious it is (severity 1–5). Source: FDA's public 483 Citations API. We display FDA's verbatim text on every CDMO profile — we do not paraphrase.
Subsystems — citations land in one of nine buckets via deterministic keyword matching on FDA's published descriptions:
Data Integrity — records, audit trails, ALCOA, electronic records, computer system validation.
Environmental Monitoring — aseptic processing, sterility, particulates, cleanroom controls.
Process Validation — qualification, IQ/OQ/PQ, media fills, cleaning validation.
CAPA — investigations, root cause, deviations, OOS handling.
Laboratory Controls — testing, stability, analytical methods, reference standards.
Equipment & Facilities — calibration, maintenance, utilities, HVAC, water systems.
Documentation & Records — SOPs, batch records, written procedures.
Personnel & Training — competency, gowning, supervision.
Other — citations not matching the eight buckets above (typically device or food regulatory citations).
Severity 1–5 uses a rules-as-floor model. Each subsystem has a deterministic floor (data integrity = 5, environmental monitoring and process validation = 4, CAPA and laboratory controls = 3, the rest = 2). For citations where the floor is below 4 and the inspector's description is long enough to merit nuance, we additionally consult Anthropic's Claude with a tight rubric. Final score is the higher of rules and LLM — Claude can promote, never demote. Tiers in the UI: 5 — Critical, 4 — Serious, 3 — Moderate, 2 — Minor, 1 — Trivial.
Validation — the rubric was tested against a 30-citation manual sample with 93% within-±1 agreement and zero LLM bias. The audit harness reruns whenever the prompt or weight table changes.
Repeat observations — flagged when the same site was previously cited for the same regulation under the same subsystem within the prior 36 months. Repeats are weighted 2× because they signal that prior CAPA failed.
Data Sources
EMA EudraGMDP — GMP certificates, non-compliance statements, and manufacturing authorizations across all EU/EEA member states.
MHRA GMDP — UK GMP certificates and non-compliance statements. Post-Brexit, UK regulatory data is separate from EudraGMDP.
ClinicalTrials.gov — 30,000+ clinical studies cross-referenced to identify CDMO manufacturing relationships.
SEC EDGAR — 10-K, 10-Q, 8-K filings for public CDMO parents. Segment 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) | 2026-05-18 |
| FDA Warning Letters | Daily (weekdays) | 2026-05-20 |
| EMA GMP Certificates | Weekly (Mon & Thu) | — |
| MHRA GMP Certificates | Manual (periodic) | — |
| ClinicalTrials.gov | Weekly (Mon & Thu) | 2026-05-18 |
| SEC EDGAR Filings | Weekly (Mon & Thu) | 2026-05-18 |
| Press Monitoring | Daily | 2026-05-20 |
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 biopharma manufacturing.
National Center — Government-backed or non-profit manufacturing centers (e.g., Cell and Gene Therapy Catapult, CCRM).