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169
CDMOs tracked
30,292
Clinical studies
909
Regulatory records
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94%
81.8
First CDMO site approved for commercial ADC manufacturing in the US, with 15+ years of conjugation experience. 22 matched clinical programs and 2 EMA GMP certificates demonstrate deep ADC track record.
✓ 2 FDA inspections with clean record
✓ 22 matched clinical programs
✓ 2 EMA GMP certificates
⚠ Both FDA inspections resulted in VAI — minor observations, no enforcement action
91%
78.6
End-to-end ADC solution from pre-clinical through commercial scale. Holds 3 EMA GMP certificates and 4 MHRA GMP certificates. 92 press articles indicate significant market activity and expanding capacity.
✓ 3 EMA GMP certificates
✓ 4 MHRA GMP certificates
✓ Expanding ADC capacity
⚠ 9 FDA 483 citations on record — review specifics for relevance to ADC operations
87%
67.0
Purpose-built ADC bioconjugation facility with 500L conjugation train and $100M+ invested in ADC modalities. Recently acquired GSK Maryland facility to expand US manufacturing footprint.
✓ 88 press articles — high market activity
✓ 0 warning letters
✓ Purpose-built ADC bioconjugation facility
⚠ No FDA inspection data for ADC-specific site — regulatory track record not yet established