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First-in-Human: Reach milestones sooner with a technology-driven approach to early-stage biologic development
White paper
For emerging biopharmaceutical drug developers, reaching critical early milestones like IND clearance and first-in-human (FiH) clinical trials can mean the difference between securing next-round funding and exhausting capital. Traditional upstream development approaches often extend timelines through trial-and-error vector design, manual optimization, and sequential workflows—increasing the risk of delays that can derail promising programs.
This white paper explores our Path to IND program, which integrates next-generation technologies to accelerate biologics from discovery to clinic while maintaining quality and regulatory compliance. By combining AI-driven vector design, advanced transposase technology, high-throughput clone selection, and intensified fed-batch processes, the platform delivers titer levels of up to 8 g/L and scales recombinant antibodies to FiH trials in just 9 to 14 months.*
Key insights:
- How AI/ML-enabled vector construction eliminates weeks of trial-and-error design work
- Why transposase and afucosylation technologies accelerate cell line development while improving product quality
- How high-throughput single-cell cloning achieved 93% efficiency with 100% monoclonality for complex bispecifics
- Real-world results showing 60% titer improvements through optimized fed-batch intensification
*Terms and Conditions: Titer levels provided are estimates based on third-party results and may vary depending on molecule type or other factors. Timelines from DNA to drug product and the start of clinical trials for all Path to IND™ for biologics options may vary depending on molecule type or other factors and are estimates to be finalized after third-party cell line development dates are available and confirmed. The 9-month timeline may incur additional risk.
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