The information you provide to the chat will be recorded to improve your experience and to contact you. Please read our privacy notice to see how we are processing and protecting your data. Click to view our Cookie Notice.
We'd love your feedback—take a quick survey to help us improve.
How can we help you today?
First in Human, faster: Reach milestones sooner with a technology-driven approach to early-stage biologic development
Discover how biopharma developers can leverage our accelerated platform to deliver titer levels of up to 8 g/L and scale recombinant antibodies to FiH trials in just 9 to 14 months.*
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 accelerated platform, which integrates next-generation technologies to streamline 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.*
Download this “First-in-Human, faster” white paper and discover:
- 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. Timeline from DNA to drug product and the start of clinical trials 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 8-month timeline will incur additional risk and is based on US-based sites only. Timeline for clinical trials is dependent on clinical trials being conducted in Australia or New Zealand.
Helpful resources
Fact sheet
Path to IND Delivers Phase I Clinical Trial Material, Fast
With Path to IND for biologics, we can deliver your large molecule drug substance for First-in-Human studies in as little as 8 months*. Learn more.
Webinar
Accelerating biologics: From final DNA to Phase I in under 9 months
Originally presented at BIO International 2025, this webinar explores how Path to IND helps biotech companies move from DNA to first-in-human Phase I clinical trials in as little as nine months.*
Case study
CHO cell culture process intensification for enhanced production of IgG mAbs
Download the case study to see how our scientists leveraged existing manufacturing platforms and facilities with CHO K1 cell lines to increase titer levels by 80% without compromising quality.