How To Deliver a High-Concentration Bispecific Antibody Tox Batch in 4 Months

Leon Tian, Director of US Project Management, ProBio, walked through the cell line development, high-concentration formulation, and purification workflow, delivering a bispecific antibody tox batch from a single selected clone in 4 to 5 months at CDMO Live Europe 2026.

Speed is always a top priority in biologic CMC development — but most of the time, speed trades against quality or regulatory confidence. What I want to show today is that this trade-off is not necessary.”

ProBio’s client brought a demanding brief: a bispecific antibody project requiring a high-concentration formulation of approximately 120 mg/mL, produced from a single selected clone, with a tox batch delivered in 4 to 5 months. Tian called it a “mission impossible” scenario, then spent the session methodically explaining how ProBio’s platform addresses each part of that challenge.

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