Dante W Romanini

Senior Scientist at Amgen

Process Development


Experienced in drug substance process development for biologics, small molecules, and conjugates at all stages of the product lifecycle.  Past and current projects include first-in-human development, commercial process development, process characterization, and validation activities.  Wide variety of modalities including bispecific antibodies, antibody-drug conjugates, biosimilars, synthetic peptides, and other conjugated proteins.


Bioprocess development skills include fed batch and perfusion cell culture, multiple harvest techniques, lab and pilot-scale chromatograpy and filtration.  Previous tech transfers to numerous internal and external manufacturing sites in USA, Europe, and India.


Current research interests focus on modern site-specific conjugation technologies and manipulating protein aggregation behavior using solution additives.

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