A Modular Platform Approach to Fast-Track Development of Complex Bispecific Antibodies

Bispecific antibodies (bsAbs) promise superior efficacy but face CMC hurdles—aggregation, mispairing, charge heterogeneity, and lower yields—that can extend timelines and costs. FUJIFILM Biotechnologies’ modular, bioinformatics‑led platform accelerates bsAb development by integrating upstream cell line development, downstream purification, and orthogonal analytics within the adaptable kojoX framework. A predict‑first screen (hydrophobic/charge patches, chemical liabilities, pI) guides platform fit and DSP triage. Upstream transfection toolboxes and chain balancing enables rapid DNA‑to‑research‑bank. Downstream, Protein A capture with charge‑ or affinity‑based polishing can be optimized via automated high‑throughput screening. Core analytics (SEC‑UPLC, CE‑SDS, icIEF, MS) ensure control. Case studies show robust assembly, high‑resolution variant clearance, and seamless translation to 2000 L cGMP.