AGC Biologics vs Catalent: CDMO Comparison

Side-by-side comparison of AGC Biologics and Catalent on independent FDA inspections, EMA and MHRA GMP certificates, clinical-program activity, and CDMO Signal Score. Data sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.

AGC Biologics → 80.6
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
Signal Score
81/100
Quality (FDA + GMP)
100/100
FDA inspections
1
— NAI / VAI / OAI
0 / 1 / 0
FDA warning letters
0
EMA GMP certificates (active)
22
MHRA GMP certificates (compliant)
0
Clinical programs (matched)
2
Capacity
Available
Modalities
CAR-T, Cell Therapy, AAV, Lentiviral
Catalent → 76.5
Somerset, NJ (now Novo Holdings)
Signal Score
76/100
Quality (FDA + GMP)
79/100
FDA inspections
10
— NAI / VAI / OAI
3 / 6 / 1
FDA warning letters
2
EMA GMP certificates (active)
14
MHRA GMP certificates (compliant)
16
Clinical programs (matched)
0
Capacity
—
Modalities
AAV, CAR-T, Lentiviral, Plasmid DNA
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Sourced from FDA, EMA EudraGMDP, MHRA GMDP, and ClinicalTrials.gov.