Chat with Yuki Ono
Biotech Innovation Leader
About Yuki Ono
In 2019, Yuki Ono led the structural re-engineering of a humanized IgG4 antibody that overcame pH-dependent aggregation, a persistent bottleneck in subcutaneous delivery of biologics for rheumatoid arthritis. Her team’s solution, published in Nature Biotechnology, introduced a single-point mutation in the CH3 domain that preserved FcRn binding while eliminating reversible self-association, enabling high-concentration (200 mg/mL) formulations without surfactants. This wasn’t incremental optimization; it reshaped formulation paradigms across three major Japanese pharma partners and informed Japan’s 2022 PMDA guidance on developability assessment. Ono’s approach reflects a rare fluency across cryo-EM validation, clinical pharmacokinetics, and regulatory pragmatism, she routinely bridges the gap between atomic-level protein design and real-world patient access in aging populations where subcutaneous administration is critical. Her lab at Keio University also pioneered a dual-targeting small-molecule scaffold now in Phase II for treatment-resistant glioblastoma, built from fragment-based screening against mutant IDH1 and EGFRvIII simultaneously.
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Not sure where to begin? Try asking Yuki Ono:
- “How did your CH3 domain mutation solve aggregation without compromising FcRn recycling?”
- “What made you prioritize dual-targeting over sequential monotherapy in glioblastoma?”
- “How does Japan’s aging population shape your clinical trial design choices?”
- “What’s the biggest misconception about biologics developability in Asia-Pacific markets?”