Angelo Perani, Ph.D
is a recognized biologics and a CMC independent consultant with more than 25 years of experience spanning therapeutic antibody development, biosimilars, cell line development, process development, manufacturing strategy, regulatory affairs, and commercializatio
Prior to consulting, Angelo served as Chief Scientific Officer at NeuClone, where he led scientific and CMC activities for more than 20 biosimilar programs. He directed cell line development, process development, analytical comparability studies, manufacturing documentation, and regulatory strategies supporting submissions to the FDA, EMA, and TGA. He also played a key role in advancing NeuCeptin and NeuLara into Phase I clinical trials.
Earlier in his career, Angelo held senior scientific and leadership positions at Lonza Biologics, the Ludwig Institute for Cancer Research, and the Olivia Newton-John Cancer Research Institute, where he developed numerous stable mammalian cell lines and led biologics manufacturing operations. At Lonza, he contributed to the development of several commercially successful biologics, including programs associated withSoliris®, Erbitux®, Vectibix®, Arzerra®, and Orencia®.
In addition to his consulting activities, Angelo serves as an Independent Member of Institutional Biosafety Committees for CSL, Seqirus, and Jumar Bio, providing expert guidance on biotechnology governance and OGTR compliance. His expertise encompasses therapeutic antibodies, biosimilars, CMC strategy, cell line development, process development, technology transfer, manufacturing readiness, comparability studies, regulatory submissions, and biologics commercialization.
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