contract
Stability Testing Services and Drug Master File Maintenance for Antibody Drug Conjugate ADCT-701
- What it is: HHS’s Office of Acquisition Management Services awarded a firm-fixed-price contract to a single vendor to perform stability testing and maintain the Drug Master File for the antibody-drug conjugate ADCT-701.
- How it was awarded: Sole-source (not competed) under FAR 6.302-1 because the agency determined only one supplier could meet the requirements.
- Why this n…
Keywords
antibody drug conjugate
stability testing
drug master file maintenance
CMC regulatory support
cGMP compliance
biologics analytical testing
pharmaceutical quality control
FDA regulatory compliance
pharmaceutical stability studies
ADCT-701
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