First-In-Human: Reach Milestones Sooner With A Technology-Driven Approach To Early-Stage Biologic Development

For emerging biopharmaceutical companies, achieving pivotal early milestones such as IND clearance and first-in-human (FiH) trials is often the defining factor between securing the next round of funding and depleting valuable capital. Conventional upstream development models — reliant on iterative vector design, manual process optimization, and stepwise workflows—can extend timelines and introduce unnecessary risk, potentially slowing or even stalling high-potential programs.

This white paper highlights our Path to IND platform, an integrated approach that leverages next-generation technologies to accelerate biologics from discovery to clinical readiness without compromising quality or regulatory compliance. By combining AI- and machine learning–enabled vector design, advanced transposase systems, high-efficiency single-cell cloning, and intensified fed-batch process strategies, the platform streamlines development while enhancing performance. Sponsors can achieve titers up to 8 g/L and progress recombinant antibody programs to FiH studies in as little as 9 to 14 months.*

Inside, you’ll discover how AI-driven vector construction reduces weeks of traditional design work; how transposase and afucosylation technologies improve both speed and product quality; how high-throughput cloning delivers 93% efficiency with confirmed monoclonality for complex bispecific molecules; and how optimized fed-batch intensification has produced real-world titer gains of up to 60%.